DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
NCT05701917 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-05-01
Summary
This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit.
Conditions
- Venous Thromboembolism
- Deep Venous Thrombosis
- Post-Thrombotic Syndrome
Interventions
- DEVICE
-
ClotTriever System
Mechanical thrombectomy
- DRUG
-
Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Anticoagulants are a group of medications that decrease your blood's ability to clot.
Sponsors & Collaborators
-
Inari Medical
lead INDUSTRY
Principal Investigators
-
Steven Abramowitz, MD · MedStar Health Research Institution
-
Xhorlina Marko, MD · Henry Ford Health
-
Stephen Black, MD · St Thomas' Hospital (UK)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-06
- Primary Completion
- 2026-06-30
- Completion
- 2027-01-15
- FDA Device
- Yes
Countries
- United States
- Austria
- Finland
- Germany
- Switzerland
- United Kingdom
Study Locations
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