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

NCT05701917 | Recruiting FDA Device

• 1 other identifier: 22-001
• Study Type: interventional
• Target: 300
• Locations: 6 countries
• Sites: 64

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.

Conditions

Deep Venous Thrombosis; Post-Thrombotic Syndrome; Venous Thromboembolism

Keywords

Venous Thromboembolism; Deep Venous Thrombosis; Post-Thrombotic Syndrome; Anticoagulation; Percutaneous Mechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:

  1. Occurrence of treatment failure or therapy escalation 2. Assessment of PTS severity, as defined by the Villalta scale

  180 Days (+-14 Days)

Secondary Outcomes (2)

• Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:

  10 Days (+- 3 Days)

• Assessment of PTS Severity:

  180 Days (+-14 Days)

Study Arms (2)

Interventional

ACTIVE COMPARATOR

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

Device: ClotTriever System

Conservative Medical Management

ACTIVE COMPARATOR

Conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm).

Drug: Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.

Interventions

Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. DRUG

Anticoagulants are a group of medications that decrease your blood's ability to clot.

Conservative Medical Management

ClotTriever System DEVICE

Mechanical thrombectomy

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Proximal lower extremity unilateral DVT involving at least the common femoral, external iliac, or common iliac veins, alone or in combination
• Symptom onset within 12 weeks of enrollment in the study
• Significant symptoms, as defined by a Villalta score \> 9
• Willing and able to provide informed consent

You may not qualify if:

• Bilateral iliofemoral DVT
• 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 enrollment
• Limb-threatening circulatory compromise (e.g., phlegmasia)
• Clot in transit including IVC thrombus presenting as extension of \>2cm into the IVC from the CIV
• Symptomatic PE with right heart strain where the physician judges that a DVT intervention is inappropriate at this time.
• Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement
• Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
• Severe allergy to iodinated contrast agents that cannot be mitigated
• Hemoglobin \< 8.0 g/dL, INR \> 1.7 before warfarin was started, or platelets \< 50,000/µl which cannot be corrected prior to enrollment
• Severe renal impairment (estimated GFR \< 30 ml/min) in patients who are not yet on dialysis
• Inability to provide therapeutic anticoagulation per Investigator discretion
• Uncontrolled severe hypertension on repeated readings (systolic \> 180mmHg or diastolic \> 105mmHg)
• Recently (\< 30 days) had DVT interventional procedure

Sponsors & Collaborators

• Inari Medical: lead

Study Sites (64)

Honor Health

Scottsdale, Arizona, 85258, United States

RECRUITING

Pima Heart and Vascular

Tucson, Arizona, 85704, United States

RECRUITING

UCI Medical Center

Orange, California, 92868, United States

RECRUITING

Vascular and Interventional Specialists of Orange County

Orange, California, 92868, United States

RECRUITING

Huntington Health

Pasadena, California, 91105, United States

RECRUITING

University Of Colorado

Denver, Colorado, 80045, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

MedStar Health Research Institution

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

TERMINATED

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

RECRUITING

Lakeland Vascular Institute

Lakeland, Florida, 33805, United States

TERMINATED

HCA Florida Largo Hospital

Largo, Florida, 33770, United States

RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

BayCare Health System

Tampa, Florida, 33607, United States

RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

TERMINATED

Community Healthcare System

Munster, Indiana, 46321, United States

TERMINATED

St. Elizabeth Edgewood

Edgewood, Kentucky, 41017, United States

TERMINATED

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

McLaren Healthcare

Bay City, Michigan, 48708, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

MyMichigan Medical Center

Midland, Michigan, 48670, United States

RECRUITING

University of Missouri

Columbia, Missouri, 65212, United States

RECRUITING

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64131, United States

TERMINATED

St. Louis University

St Louis, Missouri, 63104, United States

RECRUITING

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

RECRUITING

Cooper University Hospital

Camden, New Jersey, 08103, United States

RECRUITING

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

TERMINATED

Northwell Health

Bay Shore, New York, 11706, United States

RECRUITING

NYP-Brooklyn Methodist

Brooklyn, New York, 11215, United States

RECRUITING

SUNY, The University at Buffalo

Buffalo, New York, 14203, United States

TERMINATED

NYU Langone Medical Center

New York, New York, 10016, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Mission Health

Asheville, North Carolina, 28801, United States

TERMINATED

Mercy Health - The Heart Institute

Cincinnati, Ohio, 45211, United States

TERMINATED

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Saint Francis Hospital

Tulsa, Oklahoma, 74136, United States

RECRUITING

Allegheny St. Vincent Hospital

Erie, Pennsylvania, 16544, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Allegheny General Health Research Network

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Prisma Health Upstate

Greenville, South Carolina, 29615, United States

TERMINATED

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

RECRUITING

Lexington Medical Center

West Columbia, South Carolina, 29169, United States

TERMINATED

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Clements University Hospital (UTSW)

Dallas, Texas, 75390, United States

RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

Providence Sacred Heart Med Center

Spokane, Washington, 99204, United States

TERMINATED

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

TERMINATED

Vienna General Hospital (AKH Wien)

Vienna, Austria

RECRUITING

Helsinki University Hospital

Helsinki, Finland

RECRUITING

Universitätsklinikum Tübingen

Tübingen, Baden-Würtemberg, 72076, Germany

RECRUITING

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt am Main, Hesse, 60389, Germany

RECRUITING

Klinikum Hochsauerland GmbH

Arnsberg, North Rhine-Westphalia, 59759, Germany

RECRUITING

Universität Leipzig

Leipzig, Saxony, 04109, Germany

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

TERMINATED

Universitätsklinikum Augsburg

Augsburg, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, Germany

RECRUITING

Kantonsspital Baden

Baden, Switzerland

RECRUITING

Inselspital, Universitätsspital Bern

Bern, Switzerland

RECRUITING

Luzerner Kantonsspital

Lucerne, Switzerland

RECRUITING

GSST London/St Thomas

London, United Kingdom

RECRUITING

Imperial College

London, United Kingdom

RECRUITING

Freeman Hospital Newcastle upon Tyne

Newcastle upon Tyne, United Kingdom

RECRUITING

Oxford - John Radcliffe

Oxford, United Kingdom

RECRUITING

Related Publications (2)

• Abramowitz SD, Marko X, D'Souza D, Noor S, Pereira K, Silver MJ, Rosenberg SP, Markovitz CD, Tu T, Weinberg I, Black S. Rationale and design of the DEFIANCE study: A randomized controlled trial of mechanical thrombectomy versus anticoagulation alone for iliofemoral deep vein thrombosis. Am Heart J. 2025 Mar;281:92-102. doi: 10.1016/j.ahj.2024.10.016. Epub 2024 Nov 3.

  PMID: 39491572 RESULT

• Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.

  PMID: 39968829 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Postthrombotic Syndrome

Interventions

Warfarin; Rivaroxaban; apixaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Venous Insufficiency

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Officials

• Steven Abramowitz, MD

  MedStar Health Research Institution

  PRINCIPAL INVESTIGATOR

• Xhorlina Marko, MD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

• Stephen Black, MD

  St Thomas' Hospital (UK)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Wilhelmi

CONTACT

602-578-0738; kevin.wilhelmi@stryker.com

Sara Willis

CONTACT

sara.willis@stryker.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 27, 2023
• Study Start: January 6, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7); CH (3); AU (1); GB (4); FI (1); US (48)