DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis

Description

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

Study Overview

Study Details

Study overview

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.

DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis

DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis

Condition
Venous Thromboembolism
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Honor Health, Scottsdale, Arizona, United States, 85258

Orange

UCI Medical Center, Orange, California, United States, 92868

Orange

Vascular and Interventional Specialists of Orange County, Orange, California, United States, 92868

Denver

University Of Colorado, Denver, Colorado, United States, 80045

New Haven

Yale University, New Haven, Connecticut, United States, 06520

Washington

MedStar Health Research Institution, Washington, District of Columbia, United States, 20010

Bradenton

Manatee Memorial Hospital, Bradenton, Florida, United States, 34208

Lakeland

Lakeland Vascular Institute, Lakeland, Florida, United States, 33805

Largo

HCA Florida Largo Hospital, Largo, Florida, United States, 33770

Sarasota

Sarasota Memorial Hospital, Sarasota, Florida, United States, 34239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Inari Medical,

    Steven Abramowitz, MD, PRINCIPAL_INVESTIGATOR, MedStar Health Research Institution

    Xhorlina Marko, MD, PRINCIPAL_INVESTIGATOR, Henry Ford Health

    Stephen Black, MD, PRINCIPAL_INVESTIGATOR, St Thomas' Hospital (UK)

    Study Record Dates

    2025-10-31