Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05701917

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

Sponsor: Inari Medical

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2023-01-06

Completion Date

2027-01-15

Last Updated

2026-03-31

Healthy Volunteers

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.

Inclusion Criteria * 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 Exclusion Criteria * 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 * Subject is participating in another study that may interfere with this study * Life expectancy \< 6 months or chronic non-ambulatory status * Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period * Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (e.g., contraindication to use of ClotTriever per local approved labeling, compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments) * Subject has previously completed or withdrawn from this study * Patient unwilling or unable to conduct the follow up visits per protocol

Locations (64)

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

Huntington Health

Pasadena, California, United States

University Of Colorado

Denver, Colorado, United States

Yale University

New Haven, Connecticut, United States

MedStar Health Research Institution

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

Manatee Memorial Hospital

Bradenton, Florida, United States

Baptist Health Research Institute

Jacksonville, 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

BayCare Health System

Tampa, 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

University of Maryland

Baltimore, Maryland, United States

McLaren Healthcare

Bay City, Michigan, United States

Henry Ford Health

Detroit, Michigan, United States

MyMichigan Medical Center

Midland, 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

St Louis, Missouri, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, 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

Rhode Island Hospital

Providence, Rhode Island, 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

Vienna General Hospital (AKH Wien)

Vienna, Austria

Helsinki University Hospital

Helsinki, Finland

Universitätsklinikum Tübingen

Tübingen, Baden-Würtemberg, Germany

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt am Main, Hesse, Germany

Klinikum Hochsauerland GmbH

Arnsberg, North Rhine-Westphalia, Germany

Universität Leipzig

Leipzig, Saxony, Germany

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Universitätsklinikum Augsburg

Augsburg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Kantonsspital Baden

Baden, Switzerland

Inselspital, Universitätsspital Bern

Bern, Switzerland

Luzerner Kantonsspital

Lucerne, 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