Trial Outcomes & Findings for ClotTriever Outcomes (CLOUT) Registry (NCT NCT03575364)

Last Updated: 2025-08-26

Results Overview

The primary safety endpoint is the proportion of participants with Major Adverse Events (MAE). MAEs are defined as a composite endpoint triggered when any of four categories of events occurred through 30 days after the index procedure, as observed in the Primary Safety Cohort (the composite endpoints were not observed for the Full Analysis Population: * All-cause mortality * Major bleeding * New symptomatic pulmonary embolism (PE) documented by computed tomography pulmonary angiography (CTPA) * Rethrombosis of a target vessel segment (TVS)

Recruitment status

COMPLETED

Target enrollment

499 participants

Primary outcome timeframe

30 days

Results posted on

2025-08-26

Participant Flow

All patients presenting to the hospital/emergency department with proximal lower extremity deep vein thrombosis (DVT) and meeting all eligibility requirements for enrollment in the CLOUT study.

The first 91 subjects with unilateral acute or subacute DVT of less than or equal to 6 weeks' duration without recent (≤ 3 month) history of venous intervention were enrolled in the Primary Analysis Population. Once the Primary Analysis Population was fully accrued, subjects meeting the study criteria continued to be enrolled and were evaluated as part of the Full Analysis Population.

Participant milestones

Participant milestones
Measure	Full Analysis Population The Full Analysis Population consists of 499 subjects with proximal lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination.
Overall Study STARTED	499
Overall Study Primary Analysis Population	91
Overall Study Primary Safety Cohort	76
Overall Study Primary Effectiveness Cohort	89
Overall Study Full Analysis Population	499
Overall Study COMPLETED	285
Overall Study NOT COMPLETED	214

Reasons for withdrawal

Reasons for withdrawal
Measure	Full Analysis Population The Full Analysis Population consists of 499 subjects with proximal lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination.
Overall Study Death	45
Overall Study Lost to Follow-up	114
Overall Study Withdrawal by Subject	21
Overall Study Physician Decision	11
Overall Study Subject Refused Follow-up	13
Overall Study Hospital Administration decision, Research department closed	6
Overall Study Patient moved out of the state	1
Overall Study Patient no longer has insurance, will not return to clinic.	1
Overall Study Patient is lost to follow up	1
Overall Study Patient was unable to get to the clinic due to health problems and transportation difficulties	1

Baseline Characteristics

Fewer participants were analyzed due to missing baseline height data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Full Analysis Population n=499 Participants The Full Analysis Population consists of 499 subjects with proximal lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination.
Age, Continuous	61.85 years n=499 Participants
Sex: Female, Male Female	252 Participants n=499 Participants
Sex: Female, Male Male	247 Participants n=499 Participants
Race/Ethnicity, Customized American Indian or Alaska	4 Participants n=499 Participants
Race/Ethnicity, Customized Asian	3 Participants n=499 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=499 Participants
Race/Ethnicity, Customized Black or African American	101 Participants n=499 Participants
Race/Ethnicity, Customized White	374 Participants n=499 Participants
Race/Ethnicity, Customized More than one race	2 Participants n=499 Participants
Race/Ethnicity, Customized Other	4 Participants n=499 Participants
Race/Ethnicity, Customized Unknown or Missing	11 Participants n=499 Participants
Height (cm)	170.20 cm n=492 Participants • Fewer participants were analyzed due to missing baseline height data.
Weight (kg)	88.50 kg n=498 Participants • Fewer participants were analyzed due to missing baseline weight data.
BMI (kg/m^2)	30.203 kg/m^2 n=492 Participants • Baseline BMI data were missing for 7 subjects .

PRIMARY outcome

Timeframe: 30 days

Population: The Primary Analysis Population is a subset of the Full Analysis Population, comprising the first 91 subjects with unilateral acute or subacute DVT of less than or equal to 6 weeks duration without recent (≤ 3 month) history of venous intervention. The Primary Safety Cohort are the 76 subjects in the Primary Analysis Population who had evaluable data for the primary safety endpoint.

Outcome measures

Outcome measures
Measure	Primary Safety Cohort n=76 Participants Subjects from the Primary Analysis Population who had evaluable data for the primary safety endpoint.
Primary Safety Endpoint: Proportion Participants With Major Adverse Events	15 Participants

SECONDARY outcome

Timeframe: Index Procedure (approximately 0.5 hours on day 0)

Population: The Primary Analysis Population is a subset of the Full Analysis Population is the first 91 subjects with unilateral acute or subacute DVT of less than or equal to 6 weeks duration without recent (≤ 3 months) history of venous intervention. The Primary Effectiveness Cohort are the 89 subjects in the Primary Analysis Population with core laboratory-documented intraluminal thrombus at pre- and post- index procedure who have at least one target venous segment (TVS) treated with the study device.

Complete or near complete (≥75%) removal of venous thrombus from the TVS, as determined by the percent reduction in the Marder score for those segments. When more than one venous segment is treated, the change in Marder score is calculated as the total score for the treated segments prior to intervention with the study device (baseline score) minus the total score after treatment with the study device but before treatment with any adjunctive devices or pharmacologic agents (post-treatment score), divided by the baseline score.

Outcome measures

Outcome measures
Measure	Primary Safety Cohort n=89 Participants Subjects from the Primary Analysis Population who had evaluable data for the primary safety endpoint.
Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus	68 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Index Procedure (approximately 0.5 hours on day 0)

Population: The Full Analysis Population consists of 499 subjects with proximal lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination.

Outcome measures

Outcome measures
Measure	Primary Safety Cohort n=486 Participants Subjects from the Primary Analysis Population who had evaluable data for the primary safety endpoint.
Primary Effectiveness Endpoint (Full Analysis Population): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus	443 Participants

Adverse Events

Full Analysis Population

Serious events: 120 serious events

Other events: 76 other events

Deaths: 45 deaths

Serious adverse events

Serious adverse events
Measure	Full Analysis Population n=499 participants at risk The Full Analysis Population consists of 499 subjects with proximal lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination.
Vascular disorders Deep vein thrombosis	13.6% 68/499 • Number of events 68 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Vascular disorders Pulmonary embolism	2.2% 11/499 • Number of events 11 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Vascular disorders Cerebrovascular accident	0.60% 3/499 • Number of events 3 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Vascular disorders Blood loss anaemia	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Vascular disorders Embolism venous	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Vascular disorders Extrinsic iliac vein compression	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Vascular disorders Post thrombotic syndrome	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Vascular disorders Spontaneous haematoma	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Vascular disorders Vascular stent occlusion	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IV	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage IV	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteosarcoma	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.0% 5/499 • Number of events 5 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.40% 2/499 • Number of events 2 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Respiratory, thoracic and mediastinal disorders Malignant neoplasm of pleura metastatic	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Cardiac disorders Cardiac arrest	0.40% 2/499 • Number of events 2 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Cardiac disorders Atrial fibrillation	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Cardiac disorders Atrioventricular block	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Cardiac disorders Cardiac failure	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Cardiac disorders Cardiac failure congestive	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Cardiac disorders Myocardial infarction	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Cardiac disorders Pulseless electrical activity	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
General disorders Death	1.4% 7/499 • Number of events 7 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
General disorders Vascular stent stenosis	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Infections and infestations Septic shock	0.60% 3/499 • Number of events 3 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Infections and infestations Meningitis	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Infections and infestations Sepsis	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Infections and infestations Spinal cord infection	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.80% 4/499 • Number of events 4 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Gastrointestinal disorders Pancreatic carcinoma	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Blood and lymphatic system disorders Anaemia	0.40% 2/499 • Number of events 2 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.40% 2/499 • Number of events 2 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Injury, poisoning and procedural complications Spinal cord injury cervical	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Investigations Haemoglobin decreased	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Metabolism and nutrition disorders Dehydration	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
Renal and urinary disorders Acute kidney injury	0.20% 1/499 • Number of events 1 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).

Other adverse events

Other adverse events
Measure	Full Analysis Population n=499 participants at risk The Full Analysis Population consists of 499 subjects with proximal lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination.
Vascular disorders Deep vein thrombosis	15.2% 76/499 • Number of events 76 • All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit. This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit. Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).

Additional Information

Ashleigh Willson

Inari Medical

Phone: 925-330-3446

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place