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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05701917 on ClinicalTrials.gov