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

Not Applicable

Recruiting

• Conditions: Venous Thromboembolism; Deep Venous Thrombosis; Post-Thrombotic Syndrome
• Interventions: Device: ClotTriever System

• Registration Number: NCT05701917
• Lead Sponsor: Inari Medical

Brief 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.

Detailed Description

The study will compare the clinical outcomes of patients treated with 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 symptomatic unilateral iliofemoral DVT. Up to 300 subjects will be enrolled and randomized. All subjects who sign informed consent and who meet all of the inclusion criteria and none of the exclusion criteria will be randomized (1:1, ClotTriever Intervention Arm or Conservative Medical Management Arm).

Study Timeline

• Study Start: 2023-01-06
• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-06-30
• Study Completion: 2027-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	ClotTriever System	Interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm).

Primary Outcome Measures

Name	Time	Method
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:	180 Days (+-14 Days)	1. Occurrence of treatment failure or therapy escalation; 2. Assessment of PTS severity, as defined by the Villalta scale

Secondary Outcome Measures

Name	Time	Method
Assessment of PTS Severity:	180 Days (+-14 Days)	a. Assessment of PTS severity, as defined by the Villalta scale
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:	10 Days (+- 3 Days)	1. Vessel compressibility assessed by duplex ultrasound; 2. Pain as assessed by the NPRS; 3. An improvement of edema as assessed by leg calf circumference measurements

Trial Locations

Locations (56)

Honor Health; 🇺🇸 Scottsdale, Arizona, United States

Pima Heart and Vascular; 🇺🇸 Tucson, Arizona, United States

UCI Medical Center; 🇺🇸 Orange, California, United States

Vascular and Interventional Specialists of Orange County; 🇺🇸 Orange, California, United States

University Of Colorado; 🇺🇸 Denver, Colorado, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

MedStar Health Research Institution; 🇺🇸 Washington, District of Columbia, United States

Manatee Memorial Hospital; 🇺🇸 Bradenton, Florida, United States

Lakeland Vascular Institute; 🇺🇸 Lakeland, Florida, United States

HCA Florida Largo Hospital; 🇺🇸 Largo, Florida, United States

Sarasota Memorial Hospital; 🇺🇸 Sarasota, Florida, United States

Memorial Health University Medical Center; 🇺🇸 Savannah, Georgia, United States

Community Healthcare System; 🇺🇸 Munster, Indiana, United States

St. Elizabeth Edgewood; 🇺🇸 Edgewood, Kentucky, United States

McLaren Healthcare; 🇺🇸 Bay City, Michigan, United States

Henry Ford Health; 🇺🇸 Detroit, Michigan, United States

University of Missouri; 🇺🇸 Columbia, Missouri, United States

Saint Luke's Hospital of Kansas City; 🇺🇸 Kansas City, Missouri, United States

St. Louis University; 🇺🇸 Saint Louis, Missouri, United States

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States

Holy Name Medical Center; 🇺🇸 Teaneck, New Jersey, United States

Northwell Health; 🇺🇸 Bay Shore, New York, United States

NYP-Brooklyn Methodist; 🇺🇸 Brooklyn, New York, United States

SUNY, The University at Buffalo; 🇺🇸 Buffalo, New York, United States

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Mission Health; 🇺🇸 Asheville, North Carolina, United States

Mercy Health - The Heart Institute; 🇺🇸 Cincinnati, Ohio, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Saint Francis Hospital; 🇺🇸 Tulsa, Oklahoma, United States

Allegheny St. Vincent Hospital; 🇺🇸 Erie, Pennsylvania, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Allegheny General Health Research Network; 🇺🇸 Pittsburgh, Pennsylvania, United States

Prisma Health Upstate; 🇺🇸 Greenville, South Carolina, United States

Spartanburg Medical Center; 🇺🇸 Spartanburg, South Carolina, United States

Lexington Medical Center; 🇺🇸 West Columbia, South Carolina, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Clements University Hospital (UTSW); 🇺🇸 Dallas, Texas, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

Providence Sacred Heart Med Center; 🇺🇸 Spokane, Washington, United States

Aurora St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Baden-Würtemberg, Germany

MVZ CCB Frankfurt und Main-Taunus GbR; 🇩🇪 Frankfurt, Hessen, Germany

Klinikum Hochsauerland GmbH; 🇩🇪 Arnsberg, Nordrhein-Westfalen, Germany

Universität Leipzig; 🇩🇪 Leipzig, Sachsen, Germany

Universitätsklinikum Augsburg; 🇩🇪 Augsburg, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Kantonsspital Baden; 🇨🇭 Baden, Switzerland

Inselspital, Universitätsspital Bern; 🇨🇭 Bern, Switzerland

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland

GSST London/St Thomas; 🇬🇧 London, United Kingdom

Imperial College; 🇬🇧 London, United Kingdom

Freeman Hospital Newcastle upon Tyne; 🇬🇧 Newcastle upon Tyne, United Kingdom

Oxford - John Radcliffe; 🇬🇧 Oxford, United Kingdom