DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
- Conditions
- Venous ThromboembolismDeep Venous ThrombosisPost-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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
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
🇨ðŸ‡Baden, Switzerland
Inselspital, Universitätsspital Bern
🇨ðŸ‡Bern, Switzerland
Luzerner Kantonsspital
🇨ðŸ‡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