Trial Outcomes & Findings for The PEERLESS Study (NCT NCT05111613)
NCT ID: NCT05111613
Last Updated: 2025-11-13
Results Overview
The primary endpoint is a composite constructed as a hierarchical win ratio of the following 5 components: 1. All-cause mortality, or 2. Intracranial hemorrhage (ICH), or 3. Major bleeding per ISTH definition, or 4. Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy, or 5. ICU admission and ICU length-of-stay during the index hospitalization and following the index procedure. A win ratio larger than 1 indicates that patients who receive treatment with FlowTriever are more likely to have better outcomes as compared to subjects treated with CDT.
COMPLETED
NA
692 participants
Hospital discharge or at 7 days after the index procedure, whichever is sooner
2025-11-13
Participant Flow
Participant milestones
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
|
Non-Randomized Contraindication to Thrombolytics Cohort
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Overall Study
STARTED
|
276
|
142
|
274
|
|
Overall Study
COMPLETED
|
255
|
126
|
261
|
|
Overall Study
NOT COMPLETED
|
21
|
16
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subject reported ethnicity was unavailable in 25 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 26 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 20 subjects in the non-randomized cohort.
Baseline characteristics by cohort
| Measure |
Randomized Controlled Trial Cohort - FlowTriever Arm
n=274 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=276 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=142 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Total
n=692 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 13.0 • n=274 Participants
|
61.2 years
STANDARD_DEVIATION 14.8 • n=276 Participants
|
64.3 years
STANDARD_DEVIATION 13.9 • n=142 Participants
|
62.8 years
STANDARD_DEVIATION 14.0 • n=692 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=274 Participants
|
134 Participants
n=276 Participants
|
64 Participants
n=142 Participants
|
323 Participants
n=692 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=274 Participants
|
142 Participants
n=276 Participants
|
78 Participants
n=142 Participants
|
369 Participants
n=692 Participants
|
|
Race/Ethnicity, Customized
White
|
184 Participants
n=274 Participants
|
193 Participants
n=276 Participants
|
91 Participants
n=142 Participants
|
468 Participants
n=692 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
67 Participants
n=274 Participants
|
56 Participants
n=276 Participants
|
24 Participants
n=142 Participants
|
147 Participants
n=692 Participants
|
|
Race/Ethnicity, Customized
Other/multiple
|
3 Participants
n=274 Participants
|
7 Participants
n=276 Participants
|
4 Participants
n=142 Participants
|
14 Participants
n=692 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=274 Participants
|
0 Participants
n=276 Participants
|
2 Participants
n=142 Participants
|
2 Participants
n=692 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=274 Participants
|
3 Participants
n=276 Participants
|
1 Participants
n=142 Participants
|
4 Participants
n=692 Participants
|
|
Race/Ethnicity, Customized
Unavailable
|
20 Participants
n=274 Participants
|
17 Participants
n=276 Participants
|
20 Participants
n=142 Participants
|
57 Participants
n=692 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
13 Participants
n=249 Participants • Subject reported ethnicity was unavailable in 25 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 26 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 20 subjects in the non-randomized cohort.
|
27 Participants
n=250 Participants • Subject reported ethnicity was unavailable in 25 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 26 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 20 subjects in the non-randomized cohort.
|
21 Participants
n=122 Participants • Subject reported ethnicity was unavailable in 25 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 26 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 20 subjects in the non-randomized cohort.
|
61 Participants
n=621 Participants • Subject reported ethnicity was unavailable in 25 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 26 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 20 subjects in the non-randomized cohort.
|
|
Renal dysfunction (CrCL 30-60 mL/min)
|
43 Participants
n=274 Participants
|
45 Participants
n=276 Participants
|
33 Participants
n=142 Participants
|
121 Participants
n=692 Participants
|
|
Body Mass Index
|
34.5 kg/m^2
STANDARD_DEVIATION 8.6 • n=274 Participants • Data missing for one subject in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and one subject in the non-randomized cohort.
|
36.3 kg/m^2
STANDARD_DEVIATION 9.4 • n=275 Participants • Data missing for one subject in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and one subject in the non-randomized cohort.
|
32.0 kg/m^2
STANDARD_DEVIATION 6.7 • n=141 Participants • Data missing for one subject in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and one subject in the non-randomized cohort.
|
34.7 kg/m^2
STANDARD_DEVIATION 8.7 • n=690 Participants • Data missing for one subject in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and one subject in the non-randomized cohort.
|
|
History of cancer
|
56 Participants
n=274 Participants
|
56 Participants
n=276 Participants
|
51 Participants
n=142 Participants
|
163 Participants
n=692 Participants
|
|
Active cancer
|
13 Participants
n=274 Participants
|
17 Participants
n=276 Participants
|
39 Participants
n=142 Participants
|
69 Participants
n=692 Participants
|
|
Prior pulmonary embolism
|
41 Participants
n=274 Participants
|
31 Participants
n=276 Participants
|
12 Participants
n=142 Participants
|
84 Participants
n=692 Participants
|
|
History of pulmonary hypertension
|
6 Participants
n=274 Participants
|
5 Participants
n=276 Participants
|
7 Participants
n=142 Participants
|
18 Participants
n=692 Participants
|
|
Prior deep vein thrombosis
|
60 Participants
n=274 Participants
|
58 Participants
n=276 Participants
|
25 Participants
n=142 Participants
|
143 Participants
n=692 Participants
|
|
Concomitant deep vein thrombosis
|
178 Participants
n=274 Participants
|
168 Participants
n=276 Participants
|
90 Participants
n=142 Participants
|
436 Participants
n=692 Participants
|
|
History of bleeding
|
5 Participants
n=274 Participants
|
9 Participants
n=276 Participants
|
31 Participants
n=142 Participants
|
45 Participants
n=692 Participants
|
|
Active bleeding preprocedure
|
0 Participants
n=274 Participants
|
2 Participants
n=276 Participants
|
12 Participants
n=142 Participants
|
14 Participants
n=692 Participants
|
|
Anemia
|
21 Participants
n=274 Participants
|
27 Participants
n=276 Participants
|
47 Participants
n=142 Participants
|
95 Participants
n=692 Participants
|
|
History of renal disease
|
28 Participants
n=274 Participants
|
33 Participants
n=276 Participants
|
29 Participants
n=142 Participants
|
90 Participants
n=692 Participants
|
|
Recent surgery (within 3 weeks)
|
22 Participants
n=274 Participants
|
12 Participants
n=276 Participants
|
48 Participants
n=142 Participants
|
82 Participants
n=692 Participants
|
|
Recent trauma (within 3 weeks)
|
8 Participants
n=274 Participants
|
7 Participants
n=276 Participants
|
18 Participants
n=142 Participants
|
33 Participants
n=692 Participants
|
|
Prior cerebrovascular accident
|
7 Participants
n=274 Participants
|
8 Participants
n=276 Participants
|
17 Participants
n=142 Participants
|
32 Participants
n=692 Participants
|
|
Relative contraindication to thrombolytics
Total
|
12 Participants
n=274 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
11 Participants
n=276 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
23 Participants
n=550 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
|
Relative contraindication to thrombolytics
Anemia (hemoglobin <10 g/dL)
|
3 Participants
n=274 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
5 Participants
n=276 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
8 Participants
n=550 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
|
Relative contraindication to thrombolytics
Oral anticoagulation, except for aspirin
|
4 Participants
n=274 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
3 Participants
n=276 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
7 Participants
n=550 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
|
Relative contraindication to thrombolytics
Therapeutic LMWH within 24 hours
|
4 Participants
n=274 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
2 Participants
n=276 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
6 Participants
n=550 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
|
Relative contraindication to thrombolytics
Refractory hypertension (SBP >180 mmHg or DBP >110 mmHg on two confirmed measurements
|
1 Participants
n=274 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
2 Participants
n=276 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
3 Participants
n=550 Participants • Data for this Baseline Measure were only collected for participants in the Randomized Controlled Trial Cohorts and were not available for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort.
|
|
Absolute contraindication to thrombolytics
Total
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
142 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
142 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
|
Absolute contraindication to thrombolytics
Any other condition on the product label for use by local standard and investigator discretion
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
62 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
62 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
|
Absolute contraindication to thrombolytics
Recent (3 months) intracranial or intraspinal surgery or serious head trauma
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
32 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
32 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
|
Absolute contraindication to thrombolytics
Presence of intracranial conditions such as neoplasms, arteriovenous malformations, or aneurysms
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
24 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
24 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
|
Absolute contraindication to thrombolytics
Active internal bleeding, excluding menses
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
12 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
12 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
|
sPESI score
Score >=1
|
203 Participants
n=273 Participants • Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.
|
213 Participants
n=276 Participants • Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.
|
128 Participants
n=142 Participants • Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.
|
544 Participants
n=691 Participants • Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.
|
|
Absolute contraindication to thrombolytics
History of hemorrhagic stroke or stroke of unknown origin
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
10 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
10 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
|
Absolute contraindication to thrombolytics
Bleeding diathesis
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
10 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
10 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
|
Absolute contraindication to thrombolytics
Severe uncontrolled hypertension
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
5 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
5 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
|
Absolute contraindication to thrombolytics
Ischemic stroke in the previous 6 months
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
4 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
4 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
|
Absolute contraindication to thrombolytics
Aortic dissection
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
0 Participants
Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
2 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
2 Participants
n=142 Participants • Data for this Baseline Measure were only collected for participants in the Non-Randomized Absolute Contraindication to Thrombolytics Cohort and were not available for participants in the Randomized Controlled Trial Cohorts.
|
|
VTE-BLEED score
|
1.55 units on a scale
STANDARD_DEVIATION 1.30 • n=274 Participants
|
1.56 units on a scale
STANDARD_DEVIATION 1.31 • n=276 Participants
|
2.77 units on a scale
STANDARD_DEVIATION 1.78 • n=142 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 1.49 • n=692 Participants
|
|
VTE-BLEED score
Score >=2
|
68 Participants
n=274 Participants
|
77 Participants
n=276 Participants
|
81 Participants
n=142 Participants
|
226 Participants
n=692 Participants
|
|
VTE-BLEED score
Score <2
|
206 Participants
n=274 Participants
|
199 Participants
n=276 Participants
|
61 Participants
n=142 Participants
|
466 Participants
n=692 Participants
|
|
sPESI score
|
1.3 units on a scale
STANDARD_DEVIATION 1.1 • n=273 Participants • Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.
|
1.3 units on a scale
STANDARD_DEVIATION 1.1 • n=276 Participants • Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.
|
1.7 units on a scale
STANDARD_DEVIATION 1.1 • n=142 Participants • Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.
|
1.4 units on a scale
STANDARD_DEVIATION 1.1 • n=691 Participants • Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.
|
|
Most central PE location at screening
Main pulmonary artery
|
143 Participants
n=274 Participants
|
143 Participants
n=276 Participants
|
76 Participants
n=142 Participants
|
362 Participants
n=692 Participants
|
|
sPESI score
Score =0
|
70 Participants
n=273 Participants • Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.
|
63 Participants
n=276 Participants • Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.
|
14 Participants
n=142 Participants • Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.
|
147 Participants
n=691 Participants • Data unavailable in 1 subject in the Randomized Controlled Trial Cohort - FlowTriever Arm.
|
|
Intermediate risk PE
Intermediate-high-risk PE
|
256 Participants
n=274 Participants
|
265 Participants
n=276 Participants
|
128 Participants
n=142 Participants
|
649 Participants
n=692 Participants
|
|
Intermediate risk PE
Intermediate-low-risk PE
|
18 Participants
n=274 Participants
|
11 Participants
n=276 Participants
|
14 Participants
n=142 Participants
|
43 Participants
n=692 Participants
|
|
Duration of symptoms, days
|
2.9 days
STANDARD_DEVIATION 2.8 • n=274 Participants
|
3.5 days
STANDARD_DEVIATION 3.3 • n=276 Participants
|
2.8 days
STANDARD_DEVIATION 2.8 • n=142 Participants
|
3.1 days
STANDARD_DEVIATION 3.0 • n=692 Participants
|
|
Elevated cardiac troponin levels
|
256 Participants
n=274 Participants
|
265 Participants
n=276 Participants
|
128 Participants
n=142 Participants
|
649 Participants
n=692 Participants
|
|
Most central PE location at screening
Saddle
|
104 Participants
n=274 Participants
|
109 Participants
n=276 Participants
|
58 Participants
n=142 Participants
|
271 Participants
n=692 Participants
|
|
Most central PE location at screening
Lobar
|
27 Participants
n=274 Participants
|
24 Participants
n=276 Participants
|
8 Participants
n=142 Participants
|
59 Participants
n=692 Participants
|
|
Right bundle branch block
|
39 Participants
n=274 Participants
|
36 Participants
n=276 Participants
|
22 Participants
n=142 Participants
|
97 Participants
n=692 Participants
|
|
Heart rate, bpm
|
107.2 beats per minute
STANDARD_DEVIATION 17.1 • n=274 Participants
|
111.6 beats per minute
STANDARD_DEVIATION 20.2 • n=276 Participants
|
108.9 beats per minute
STANDARD_DEVIATION 17.2 • n=142 Participants
|
109.3 beats per minute
STANDARD_DEVIATION 18.5 • n=692 Participants
|
|
Respiratory rate, rpm
|
22.2 respirations per minute
STANDARD_DEVIATION 6.7 • n=274 Participants • Data unavailable for 1 subject in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 1 subject in the non-randomized cohort.
|
22.4 respirations per minute
STANDARD_DEVIATION 5.9 • n=275 Participants • Data unavailable for 1 subject in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 1 subject in the non-randomized cohort.
|
23.1 respirations per minute
STANDARD_DEVIATION 6.7 • n=141 Participants • Data unavailable for 1 subject in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 1 subject in the non-randomized cohort.
|
22.5 respirations per minute
STANDARD_DEVIATION 6.4 • n=690 Participants • Data unavailable for 1 subject in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 1 subject in the non-randomized cohort.
|
|
Systolic blood pressure at diagnosis, mmHg
|
134.0 mmHg
STANDARD_DEVIATION 22.4 • n=274 Participants • Data unavailable for 1 subject in the non-randomized cohort.
|
132.1 mmHg
STANDARD_DEVIATION 21.7 • n=276 Participants • Data unavailable for 1 subject in the non-randomized cohort.
|
127.7 mmHg
STANDARD_DEVIATION 23.7 • n=141 Participants • Data unavailable for 1 subject in the non-randomized cohort.
|
132.0 mmHg
STANDARD_DEVIATION 22.5 • n=691 Participants • Data unavailable for 1 subject in the non-randomized cohort.
|
|
Diastolic blood pressure at diagnosis, mmHg
|
83.8 mmHg
STANDARD_DEVIATION 14.7 • n=274 Participants • Data unavailable for 1 subject in the non-randomized cohort.
|
84.1 mmHg
STANDARD_DEVIATION 14.7 • n=276 Participants • Data unavailable for 1 subject in the non-randomized cohort.
|
80.0 mmHg
STANDARD_DEVIATION 14.6 • n=141 Participants • Data unavailable for 1 subject in the non-randomized cohort.
|
83.2 mmHg
STANDARD_DEVIATION 14.8 • n=691 Participants • Data unavailable for 1 subject in the non-randomized cohort.
|
|
mMRC dyspnea score
Score 0 - Dyspnea only with strenuous exercise
|
16 Participants
n=271 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
12 Participants
n=273 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
9 Participants
n=138 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
37 Participants
n=682 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
|
mMRC dyspnea score
Score 1 - Dyspnea when hurrying or walking up a slight hill
|
23 Participants
n=271 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
17 Participants
n=273 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
5 Participants
n=138 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
45 Participants
n=682 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
|
mMRC dyspnea score
Score 2 - Walks slower than people of same age due to dyspnea or has to stop for breath when walking
|
37 Participants
n=271 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
39 Participants
n=273 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
13 Participants
n=138 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
89 Participants
n=682 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
|
mMRC dyspnea score
Score 3 - Stops for breath after walking 100 yards (91 m) or after a few minutes
|
87 Participants
n=271 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
79 Participants
n=273 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
36 Participants
n=138 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
202 Participants
n=682 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
|
mMRC dyspnea score
Score 4 - Too dyspneic to leave house or breathless when dressing
|
108 Participants
n=271 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
126 Participants
n=273 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
75 Participants
n=138 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
309 Participants
n=682 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 4 subjects in the non-randomized cohort.
|
|
NYHA classification
Class I - No limitation of physical activity
|
26 Participants
n=272 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
19 Participants
n=273 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
13 Participants
n=139 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
58 Participants
n=684 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
|
NYHA classification
Class II - Slight limitation of physical activity
|
54 Participants
n=272 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
51 Participants
n=273 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
11 Participants
n=139 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
116 Participants
n=684 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
|
RV function on echocardiogram
Moderately reduced
|
42 Participants
n=178 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
41 Participants
n=171 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
19 Participants
n=80 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
102 Participants
n=429 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
|
NYHA classification
Class III - Marked limitation of physical activity
|
122 Participants
n=272 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
127 Participants
n=273 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
58 Participants
n=139 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
307 Participants
n=684 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
|
NYHA classification
Class IV - Unable to carry on any physical activity without discomfort
|
70 Participants
n=272 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
76 Participants
n=273 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
57 Participants
n=139 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
203 Participants
n=684 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 3 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
|
Modified Borg dyspnea score
|
3.12 units on a scale
STANDARD_DEVIATION 2.63 • n=274 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 7 subjects in the non-randomized cohort.
|
3.32 units on a scale
STANDARD_DEVIATION 2.58 • n=274 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 7 subjects in the non-randomized cohort.
|
3.93 units on a scale
STANDARD_DEVIATION 2.96 • n=135 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 7 subjects in the non-randomized cohort.
|
3.36 units on a scale
STANDARD_DEVIATION 2.69 • n=683 Participants • Data unavailable for 2 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 7 subjects in the non-randomized cohort.
|
|
RV/LV ratio (CTPA or echocardiogram)
|
1.27 ratio
STANDARD_DEVIATION 0.26 • n=262 Participants • Data unavailable for 12 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 16 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 14 subjects in the non-randomized cohort.
|
1.31 ratio
STANDARD_DEVIATION 0.27 • n=260 Participants • Data unavailable for 12 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 16 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 14 subjects in the non-randomized cohort.
|
1.31 ratio
STANDARD_DEVIATION 0.33 • n=128 Participants • Data unavailable for 12 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 16 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 14 subjects in the non-randomized cohort.
|
1.29 ratio
STANDARD_DEVIATION 0.28 • n=650 Participants • Data unavailable for 12 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 16 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 14 subjects in the non-randomized cohort.
|
|
RV function on echocardiogram
Normal
|
1 Participants
n=178 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
0 Participants
n=171 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
2 Participants
n=80 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
3 Participants
n=429 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
|
RV function on echocardiogram
Mildly reduced
|
13 Participants
n=178 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
11 Participants
n=171 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
3 Participants
n=80 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
27 Participants
n=429 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
|
RV function on echocardiogram
Severely reduced
|
122 Participants
n=178 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
119 Participants
n=171 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
56 Participants
n=80 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
297 Participants
n=429 Participants • Only subjects with RV function collected at both the Baseline and 24 Hour Visit are reported here, resulting in unavailable data for 96 subjects in the RCT FlowTriever cohort, 105 subjects in the RCT CDT cohort, and 62 subjects in the non-randomized cohort.
|
|
Parenteral anticoagulation use at baseline
UFH and/or LMWH: Total
|
261 Participants
n=274 Participants
|
267 Participants
n=276 Participants
|
135 Participants
n=142 Participants
|
663 Participants
n=692 Participants
|
|
Parenteral anticoagulation use at baseline
UFH and/or LMWH: UFH
|
221 Participants
n=274 Participants
|
236 Participants
n=276 Participants
|
120 Participants
n=142 Participants
|
577 Participants
n=692 Participants
|
|
Parenteral anticoagulation use at baseline
UFH and/or LMWH: LMWH
|
25 Participants
n=274 Participants
|
24 Participants
n=276 Participants
|
10 Participants
n=142 Participants
|
59 Participants
n=692 Participants
|
|
Parenteral anticoagulation use at baseline
UFH and/or LMWH: UFH and LMWH
|
15 Participants
n=274 Participants
|
7 Participants
n=276 Participants
|
5 Participants
n=142 Participants
|
27 Participants
n=692 Participants
|
|
Parenteral anticoagulation use at baseline
Another parenteral agent
|
0 Participants
n=274 Participants
|
1 Participants
n=276 Participants
|
0 Participants
n=142 Participants
|
1 Participants
n=692 Participants
|
|
Parenteral anticoagulation use at baseline
None
|
13 Participants
n=274 Participants
|
8 Participants
n=276 Participants
|
7 Participants
n=142 Participants
|
28 Participants
n=692 Participants
|
|
Time from study hospital presentation to treatment catheter insertion, hours
|
22.3 hours
STANDARD_DEVIATION 17.7 • n=271 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 5 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
24.9 hours
STANDARD_DEVIATION 19.7 • n=271 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 5 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
38.3 hours
STANDARD_DEVIATION 62.8 • n=139 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 5 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
26.6 hours
STANDARD_DEVIATION 33.4 • n=681 Participants • Data unavailable for 3 subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm, 5 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm, and 3 subjects in the non-randomized cohort.
|
|
mPAP, mmHg
|
30.0 mmHg
STANDARD_DEVIATION 7.6 • n=274 Participants • Data unavailable for 6 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 1 subject in the non-randomized cohort.
|
31.1 mmHg
STANDARD_DEVIATION 7.2 • n=270 Participants • Data unavailable for 6 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 1 subject in the non-randomized cohort.
|
29.7 mmHg
STANDARD_DEVIATION 7.5 • n=141 Participants • Data unavailable for 6 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 1 subject in the non-randomized cohort.
|
30.4 mmHg
STANDARD_DEVIATION 7.4 • n=685 Participants • Data unavailable for 6 subjects in the Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm and 1 subject in the non-randomized cohort.
|
PRIMARY outcome
Timeframe: Hospital discharge or at 7 days after the index procedure, whichever is soonerPopulation: Enrolled subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm and Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm were assessed for this Outcome Measure.
The primary endpoint is a composite constructed as a hierarchical win ratio of the following 5 components: 1. All-cause mortality, or 2. Intracranial hemorrhage (ICH), or 3. Major bleeding per ISTH definition, or 4. Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy, or 5. ICU admission and ICU length-of-stay during the index hospitalization and following the index procedure. A win ratio larger than 1 indicates that patients who receive treatment with FlowTriever are more likely to have better outcomes as compared to subjects treated with CDT.
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=276 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=274 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Primary Endpoint: Composite Clinical Endpoint Constructed as a 5-Component Win Ratio
|
10509 Number of Wins for the group
|
—
|
52693 Number of Wins for the group
|
SECONDARY outcome
Timeframe: Hospital discharge or at 7 days after the index procedure, whichever is soonerPopulation: Enrolled subjects in the Randomized Controlled Trial Cohort - FlowTriever Arm and Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm were assessed for this Outcome Measure.
This secondary endpoint is a composite constructed as a hierarchical win ratio of the following 4 components: * All-cause mortality, or * Intracranial hemorrhage (ICH), or * Major bleeding per ISTH definition, or * Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy A win ratio larger than 1 indicates that patients who receive treatment with FlowTriever are more likely to have better outcomes as compared to subjects treated with CDT.
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=276 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=274 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Composite Clinical Endpoint Constructed as a 4-Component Win Ratio
|
5912 Number of Wins for the group
|
—
|
7925 Number of Wins for the group
|
SECONDARY outcome
Timeframe: Hospital discharge or at 7 days after the index procedure, whichever is soonerPopulation: All enrolled subjects
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=276 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=142 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=274 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
All-cause Mortality
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge or at 7 days after the index procedure, whichever is soonerPopulation: All enrolled subjects with available outcome
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=275 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=142 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=274 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Intracranial Hemorrhage (ICH)
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge or at 7 days after the index procedure, whichever is soonerPopulation: All enrolled subjects
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=276 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=142 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=274 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Major Bleeding Per ISTH Definition
|
19 Participants
|
10 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge or at 7 days after the index procedure, whichever is soonerPopulation: All enrolled subjects
Clinical deterioration is defined as documented objective hemodynamic or respiratory worsening that is new (i.e. not present at the time of enrollment). Bailout therapy is an unplanned escalation of therapeutic measures, taken when the patient's condition has not improved or is not improving according to expectations.
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=276 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=142 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=274 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Clinical Deterioration Defined by Hemodynamic or Respiratory Worsening, and/or Escalation to a Bailout Therapy
|
15 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge or at 7 days after the index procedure, whichever is soonerPopulation: All enrolled subjects
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=276 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=142 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=274 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
ICU Admission During the Index Hospitalization and Following the Index Procedure
|
272 Participants
|
65 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge or at 7 days after the index procedure, whichever is soonerPopulation: All enrolled subjects with available outcome
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=272 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=65 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=114 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
ICU Length of Stay During the Index Hospitalization and Following the Index Procedure Among Subjects With ICU Admission.
ICU length of stay 0-24 hours
|
94 Participants
|
30 Participants
|
61 Participants
|
|
ICU Length of Stay During the Index Hospitalization and Following the Index Procedure Among Subjects With ICU Admission.
ICU length of stay >24 hours
|
178 Participants
|
35 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: 30 days from index procedurePopulation: All enrolled subjects with available outcome
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=240 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=127 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=251 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
All Cause Mortality
|
2 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days from index procedurePopulation: All enrolled subjects with available outcome
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=239 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=124 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=251 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
All-cause and PE-related Readmissions
PE-related readmission
|
2 Participants
|
1 Participants
|
0 Participants
|
|
All-cause and PE-related Readmissions
All-cause readmission
|
19 Participants
|
13 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Through the 30 day visitPopulation: All enrolled subjects with available outcome
Device-related SAEs included those adjudicated by the CEC to be related to the interventional device.
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=240 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=123 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=254 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Device-related Serious Adverse Events
|
12 Participants
|
9 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Through the 30 day visitPopulation: All enrolled subjects with available outcome
Drug-related SAEs included those adjudicated by the CEC to be related to anticoagulation and/or thrombolytics medication.
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=244 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=123 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=254 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Drug-related Serious Adverse Events
|
28 Participants
|
18 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Hospital discharge or at 7 days after the index procedure, whichever is soonerPopulation: All enrolled subjects with available outcome
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=275 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=142 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=274 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Clinically Relevant Non-Major (CRNM) and Minor Bleeding Events
Clinically relevant non-major (CRNM) bleeding events
|
9 Participants
|
6 Participants
|
7 Participants
|
|
Clinically Relevant Non-Major (CRNM) and Minor Bleeding Events
Minor bleeding events
|
1 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline to 24 hour visitPopulation: All enrolled subjects with available outcome
Assessments of change were made using the same imaging modality at baseline and at the 24-hour visit.
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=259 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=127 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=259 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Change in Right-ventricular/Left-ventricular (RV/LV) Ratio, as Measured by Echocardiography or CT
|
-0.30 ratio
Standard Deviation 0.26
|
-0.38 ratio
Standard Deviation 0.29
|
-0.32 ratio
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: At 24 hour visitPopulation: All enrolled subjects with available outcome
The mMRC score is reported on a 0-4 scale with lower scores representing less dyspnea.
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=250 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=130 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=259 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Modified Medical Research Council (mMRC) Dyspnea Score at 24 Hour Visit
Score 0 - Dyspnea only with strenuous exercise
|
77 Participants
|
40 Participants
|
80 Participants
|
|
Modified Medical Research Council (mMRC) Dyspnea Score at 24 Hour Visit
Score 1 - Dyspnea when hurrying or walking up a slight hill
|
54 Participants
|
35 Participants
|
83 Participants
|
|
Modified Medical Research Council (mMRC) Dyspnea Score at 24 Hour Visit
Score 2 - Walks slower than people of the same age due to dyspnea or stops for breath when walking
|
53 Participants
|
29 Participants
|
61 Participants
|
|
Modified Medical Research Council (mMRC) Dyspnea Score at 24 Hour Visit
Score 3 - Stops for breath after walking 100 yards (91 m) or after a few minutes
|
44 Participants
|
21 Participants
|
27 Participants
|
|
Modified Medical Research Council (mMRC) Dyspnea Score at 24 Hour Visit
Score 4 - Too dyspneic to leave house or breathless when dressing
|
22 Participants
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: At 30 day visitPopulation: All enrolled subjects with available outcome
The mMRC score is reported on a 0-4 scale with lower scores representing less dyspnea.
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=254 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=121 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=258 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Modified Medical Research Council (mMRC) Dyspnea Score at 30 Day Visit
Score 0 - Dyspnea only with strenuous exercise
|
138 Participants
|
60 Participants
|
137 Participants
|
|
Modified Medical Research Council (mMRC) Dyspnea Score at 30 Day Visit
Score 1 - Dyspnea when hurrying or walking up a slight hill
|
63 Participants
|
33 Participants
|
74 Participants
|
|
Modified Medical Research Council (mMRC) Dyspnea Score at 30 Day Visit
Score 2 - Walks slower than people of the same age due to dyspnea or stops for breath when walking
|
27 Participants
|
17 Participants
|
28 Participants
|
|
Modified Medical Research Council (mMRC) Dyspnea Score at 30 Day Visit
Score 3 - Stops for breath after walking 100 yards (91 m) or after a few minutes
|
23 Participants
|
6 Participants
|
14 Participants
|
|
Modified Medical Research Council (mMRC) Dyspnea Score at 30 Day Visit
Score 4 - Too dyspneic to leave house or breathless when dressing
|
3 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Through 30 days post-procedurePopulation: All enrolled subjects
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=276 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=142 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=274 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Length of Total Hospital Stay
|
5.3 hospital overnights
Standard Deviation 3.9
|
7.8 hospital overnights
Standard Deviation 7.4
|
4.5 hospital overnights
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Through 30 days post-procedurePopulation: All enrolled subjects
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=276 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=142 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=274 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Length of Post-index-procedure Hospital Stay
|
4.0 days
Standard Deviation 3.71
|
5.4 days
Standard Deviation 5.80
|
3.2 days
Standard Deviation 2.72
|
SECONDARY outcome
Timeframe: At 30 day visitPopulation: All enrolled subjects with available outcome
The Pulmonary Embolism Quality of Life (PEmb-QOL) questionnaire is used to assess the quality of life in patients with pulmonary embolism (PE). It is a disease-specific tool designed to evaluate the impact of PE on various aspects of a patient's life, including daily activities, work, social life, and emotional well-being, and is reported on a 0-100 scale with lower scores representing better quality of life.
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=253 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=123 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=260 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Pulmonary Embolism Quality of Life (PEmb-QOL) Score at 30 Day Visit
|
20.42 score on a scale
Standard Deviation 19.95
|
23.50 score on a scale
Standard Deviation 21.75
|
19.33 score on a scale
Standard Deviation 18.91
|
SECONDARY outcome
Timeframe: At 30 day visitPopulation: All enrolled subjects with available outcome
Each of the five dimensions comprising the EQ-5D-5L descriptive system (mobility, self-care, usual activates, pain/discomfort, anxiety/depression) are graded from 1 (no problems) to 5 (extreme problems). A descriptive health state is defined by combining each level for 5 dimensions into a 5-digit code (e.g., 12345) which is then mapped to the health state index score based on a country-specific value set. Health state index scores range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health).
Outcome measures
| Measure |
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=255 Participants
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=123 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - FlowTriever Arm
n=259 Participants
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
EQ-5D-5L Quality of Life Score at 30 Day Visit
|
0.817 score on a scale
Standard Deviation 0.237
|
0.742 score on a scale
Standard Deviation 0.284
|
0.829 score on a scale
Standard Deviation 0.218
|
Adverse Events
Randomized Controlled Trial Cohort - FlowTriever Arm
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
Serious adverse events
| Measure |
Randomized Controlled Trial Cohort - FlowTriever Arm
n=274 participants at risk
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=276 participants at risk
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=142 participants at risk
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.73%
2/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Hypotension
|
0.73%
2/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
1.1%
3/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Syncope
|
0.73%
2/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Abdominal wall haematoma
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Cerebral haemorrhage
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Haematoma
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Cerebrovascular accident
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
1.4%
2/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Heparin-induced thrombocytopenia
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Postmenopausal haemorrhage
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Pulmonary embolism
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
1.4%
4/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Chest wall haematoma
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Presyncope
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Embolic stroke
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Gangrene
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Haematoma muscle
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
2.6%
7/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
2.5%
7/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
1.1%
3/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Injury, poisoning and procedural complications
Catheter site haematoma
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Injury, poisoning and procedural complications
Orbital haemorrhage
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Injury, poisoning and procedural complications
Postoperative wound infection
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
3.5%
5/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
2.1%
3/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Dyspnoea
|
0.73%
2/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Cardiac arrest
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
1.4%
2/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
1.4%
2/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
3/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.72%
2/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
1.4%
2/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
1.1%
3/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
1.4%
2/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Haematochezia
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Melaena
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
General disorders
Chest pain
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.72%
2/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Mesenteric neoplasm
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Infections and infestations
Bacteraemia
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Infections and infestations
Diverticulitis
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Infections and infestations
Septic shock
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
1.4%
2/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Renal and urinary disorders
Haematuria
|
1.1%
3/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.72%
2/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.72%
2/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Renal and urinary disorders
Renal transplant failure
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Investigations
Haemoglobin decreased
|
0.73%
2/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.72%
2/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
General disorders
Alcohol withdrawal syndrome
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
General disorders
Death
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
General disorders
Generalised oedema
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
General disorders
Oedema peripheral
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.72%
2/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.72%
2/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Surgical and medical procedures
Catheter directed thrombolysis
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Surgical and medical procedures
Thrombectomy
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Surgical and medical procedures
Arterial puncture
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Surgical and medical procedures
Lung assist device therapy
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Musculoskeletal and connective tissue disorders
Osteorrhagia
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
Other adverse events
| Measure |
Randomized Controlled Trial Cohort - FlowTriever Arm
n=274 participants at risk
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
n=276 participants at risk
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system).
|
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
n=142 participants at risk
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
2.2%
6/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
1.1%
3/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.73%
2/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.73%
2/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Non-small cell lung cancer
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.72%
2/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Bradycardia
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Cardiogenic shock
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.72%
2/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Ascites
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Colitis
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Infections and infestations
Pneumonia
|
0.73%
2/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Infections and infestations
Urinary tract infection
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Infections and infestations
Infection
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Haematoma
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Orthostatic hypotension
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Cerebrovascular accident
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
General disorders
Swelling face
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Vascular disorders
Epistaxis
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
General disorders
Necrosis
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
General disorders
Oedema peripheral
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Investigations
Right ventricular systolic pressure decreased
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Investigations
Respiratory rate increased
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Investigations
Transaminases increased
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Psychiatric disorders
Mental status changes
|
0.36%
1/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.72%
2/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.70%
1/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic uterine cancer
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/274 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.36%
1/276 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
0.00%
0/142 • Adverse events collected from time of enrollment through 30 Day visit or study exit, if exited early. For European subjects, reporting began after signing informed consent, while US subjects reporting began after the study device entered the vasculature. The All-Cause Mortality field reports all deaths reported through study exit and from vital status tracing after exit (including cases of sponsor awareness after exit), differing slightly from the 30-day all-cause mortality secondary endpoint.
All CEC adjudicated events (all SAEs and non-serious AEs potentially related to a primary/secondary endpoint reported prior to study exit) as well as non-adjudicated events known from vital status tracing in subjects lost to follow-up are listed here. Mortality status is known at the earlier of study exit or day 30 for everyone except 2 RCT subjects lost to follow-up. The all-cause mortality rate excluding these subjects is 1.1% (3/273) for the FlowTriever arm and 0.7% (2/275) for the CDT arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60