DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
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
Interventions
ClotTriever System
Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Conditions
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