N/A
Completed N=499
ClotTriever Outcomes (CLOUT) Registry
Deep Vein Thrombosis Leg · DVT · Chronic DVT of Lower Extremity · Acute DVT of Lower Extremity
Source: ClinicalTrials.gov NCT03575364 ↗
Enrolled (actual)
499
Serious AEs
24.1%
Results posted
Aug 2025
Primary outcomePrimary: Primary Safety Endpoint: Proportion Participants With Major Adverse Events — 15 Participants
Summary
Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint: Proportion Participants With Major Adverse Events |
15 | — |
| SECONDARY Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus |
68 | — |
Eligibility Criteria
Inclusion Criteria
- Proximal lower extremity DVT involving the femoral, common femoral, iliac veins, or inferior vena cava (IVC), alone or in combination.
- Willing and able to provide informed consent.
Exclusion Criteria
- Prior venous stent in the target venous segment
- IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins
- IVC filter in place at the time of the planned index procedure
- Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used
- Life expectancy less than 1 year
- Chronic non-ambulatory status
- Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically-managed throughout the study period
- Unavailability of a lower extremity venous access site
Data sourced from ClinicalTrials.gov (NCT03575364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.