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NCT05701917NARecruiting

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

Inari Medical

Start Date

1/6/2023

Completion Date

7/31/2028

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. Approximately 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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

ClotTriever System

DRUG

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

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Conditions

Venous ThromboembolismDeep Venous ThrombosisPost-Thrombotic Syndrome

Locations

Honor Health

Scottsdale, Arizona 85258

United States

Pima Heart and Vascular

Tucson, Arizona 85704

United States

UCI Medical Center

Orange, California 92868

United States

Vascular and Interventional Specialists of Orange County

Orange, California 92868

United States

Huntington Health

Pasadena, California 91105

United States

University Of Colorado

Denver, Colorado 80045

United States

Yale University

New Haven, Connecticut 06520

United States

MedStar Health Research Institution

Washington D.C., District of Columbia 20010

United States

Manatee Memorial Hospital

Bradenton, Florida 34208

United States

Baptist Health Research Institute

Jacksonville, Florida 32207

United States

Lakeland Vascular Institute

Lakeland, Florida 33805

United States

HCA Florida Largo Hospital

Largo, Florida 33770

United States

Sarasota Memorial Hospital

Sarasota, Florida 34239

United States

BayCare Health System

Tampa, Florida 33607

United States

Memorial Health University Medical Center

Savannah, Georgia 31404

United States

Community Healthcare System

Munster, Indiana 46321

United States

St. Elizabeth Edgewood

Edgewood, Kentucky 41017

United States

University of Maryland

Baltimore, Maryland 21201

United States

McLaren Healthcare

Bay City, Michigan 48708

United States

Henry Ford Health

Detroit, Michigan 48202

United States

MyMichigan Medical Center

Midland, Michigan 48670

United States

University of Missouri

Columbia, Missouri 65212

United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri 64131

United States

St. Louis University

St Louis, Missouri 63104

United States

University Medical Center of Southern Nevada

Las Vegas, Nevada 89102

United States

Cooper University Hospital

Camden, New Jersey 08103

United States

Holy Name Medical Center

Teaneck, New Jersey 07666

United States

Northwell Health

Bay Shore, New York 11706

United States

NYP-Brooklyn Methodist

Brooklyn, New York 11215

United States

SUNY, The University at Buffalo

Buffalo, New York 14203

United States

NYU Langone Medical Center

New York, New York 10016

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

Mission Health

Asheville, North Carolina 28801

United States

Mercy Health - The Heart Institute

Cincinnati, Ohio 45211

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Saint Francis Hospital

Tulsa, Oklahoma 74136

United States

Allegheny St. Vincent Hospital

Erie, Pennsylvania 16544

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Allegheny General Health Research Network

Pittsburgh, Pennsylvania 15212

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

Prisma Health Upstate

Greenville, South Carolina 29615

United States

Spartanburg Medical Center

Spartanburg, South Carolina 29303

United States

Lexington Medical Center

West Columbia, South Carolina 29169

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Clements University Hospital (UTSW)

Dallas, Texas 75390

United States

Sentara Norfolk General Hospital

Norfolk, Virginia 23507

United States

Providence Sacred Heart Med Center

Spokane, Washington 99204

United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin 53215

United States

Vienna General Hospital (AKH Wien)

Vienna,

Austria

Helsinki University Hospital

Helsinki,

Finland

Universitätsklinikum Tübingen

Tübingen, Baden-Würtemberg 72076

Germany

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt am Main, Hesse 60389

Germany

Klinikum Hochsauerland GmbH

Arnsberg, North Rhine-Westphalia 59759

Germany

Universität Leipzig

Leipzig, Saxony 04109

Germany

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin 10117

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