Trial Outcomes & Findings for FlowTriever Pulmonary Embolectomy Clinical Study (NCT NCT02692586)
NCT ID: NCT02692586
Last Updated: 2021-05-24
Results Overview
Change in RV/LV ratio from baseline to 48 hours
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
Baseline to 48 hours
Results posted on
2021-05-24
Participant Flow
Participant milestones
| Measure |
FlowTriever System
FlowTriever System
|
|---|---|
|
Overall Study
STARTED
|
106
|
|
Overall Study
COMPLETED
|
103
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
FlowTriever System
FlowTriever System
|
|---|---|
|
Overall Study
Death from undiagnosed breast cancer through 30-day follow-up
|
1
|
|
Overall Study
Received adjunctive thrombolytics
|
2
|
Baseline Characteristics
FlowTriever Pulmonary Embolectomy Clinical Study
Baseline characteristics by cohort
| Measure |
FlowTriever System
n=104 Participants
FlowTriever System
|
|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Pre-procedural RV/LV ratio
|
1.56 ratio
STANDARD_DEVIATION 0.34 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 48 hoursPopulation: Patients with symptomatic, computed tomography-documented PE and RV/LV ratios ≥ 0.9 treated with the FlowTriever System that were not administered thrombolytic agents during the index procedure (n = 104)
Change in RV/LV ratio from baseline to 48 hours
Outcome measures
| Measure |
FlowTriever System
n=104 Participants
Patients treated with the FlowTriever System
|
|---|---|
|
Change in RV/LV Ratio
|
0.38 RV/LV ratio
Standard Error 0.03
|
PRIMARY outcome
Timeframe: Within 48 hoursPopulation: Patients with symptomatic, computed tomography-documented PE and RV/LV ratios ≥ 0.9 treated with the FlowTriever System that were not administered thrombolytic agents during the index procedure (n = 104)
Device-related death, major bleeding, and treatment related AEs
Outcome measures
| Measure |
FlowTriever System
n=104 Participants
Patients treated with the FlowTriever System
|
|---|---|
|
Number of Participants With Major Adverse Events
Participants experiencing MAEs
|
4 Participants
|
|
Number of Participants With Major Adverse Events
Participants not experiencing MAEs
|
100 Participants
|
Adverse Events
FlowTriever System
Serious events: 14 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
FlowTriever System
n=106 participants at risk
FlowTriever System
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.94%
1/106 • Number of events 2 • 30 +/- 3 days
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Cardiac disorders
Coronary artery stenosis
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Cardiac disorders
Myocardial ischaemia
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Gastrointestinal disorders
Ileus
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
General disorders
Catheter site hematoma
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Infections and infestations
Pneumonia
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Infections and infestations
Respiratory tract infection
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Infections and infestations
Sepsis
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Injury, poisoning and procedural complications
Postoperative renal failure
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Metabolism and nutrition disorders
Acute respiratory failure
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Metabolism and nutrition disorders
Respiratory failure
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
2/106 • Number of events 2 • 30 +/- 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.94%
1/106 • Number of events 1 • 30 +/- 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
1.9%
2/106 • Number of events 2 • 30 +/- 3 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place