DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis
Status: Recruiting
Location: See all (60) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Honor Health
RECRUITING
Scottsdale
Pima Heart and Vascular
RECRUITING
Tucson
California
UCI Medical Center
RECRUITING
Orange
Vascular and Interventional Specialists of Orange County
RECRUITING
Orange
Colorado
University Of Colorado
RECRUITING
Denver
Connecticut
Yale University
RECRUITING
New Haven
Washington, D.c.
MedStar Health Research Institution
RECRUITING
Washington D.c.
Florida
Manatee Memorial Hospital
TERMINATED
Bradenton
Lakeland Vascular Institute
TERMINATED
Lakeland
HCA Florida Largo Hospital
RECRUITING
Largo
Sarasota Memorial Hospital
RECRUITING
Sarasota
BayCare Health System
RECRUITING
Tampa
Georgia
Memorial Health University Medical Center
TERMINATED
Savannah
Indiana
Community Healthcare System
TERMINATED
Munster
Kentucky
St. Elizabeth Edgewood
RECRUITING
Edgewood
Maryland
University of Maryland
RECRUITING
Baltimore
Michigan
McLaren Healthcare
RECRUITING
Bay City
Henry Ford Health
RECRUITING
Detroit
MyMichigan Medical Center
RECRUITING
Midland
Missouri
University of Missouri
RECRUITING
Columbia
Saint Luke's Hospital of Kansas City
TERMINATED
Kansas City
St. Louis University
RECRUITING
St Louis
North Carolina
Mission Health
TERMINATED
Asheville
New Jersey
Cooper University Hospital
RECRUITING
Camden
Holy Name Medical Center
SUSPENDED
Teaneck
Nevada
University Medical Center of Southern Nevada
RECRUITING
Las Vegas
New York
Northwell Health
RECRUITING
Bay Shore
NYP-Brooklyn Methodist
RECRUITING
Brooklyn
SUNY, The University at Buffalo
RECRUITING
Buffalo
Columbia University Irving Medical Center
RECRUITING
New York
NYU Langone Medical Center
RECRUITING
New York
Ohio
Mercy Health - The Heart Institute
TERMINATED
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Oklahoma
Saint Francis Hospital
RECRUITING
Tulsa
Pennsylvania
Allegheny St. Vincent Hospital
RECRUITING
Erie
Thomas Jefferson University
RECRUITING
Philadelphia
Allegheny General Health Research Network
RECRUITING
Pittsburgh
South Carolina
Prisma Health Upstate
TERMINATED
Greenville
Spartanburg Medical Center
RECRUITING
Spartanburg
Lexington Medical Center
RECRUITING
West Columbia
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Clements University Hospital (UTSW)
RECRUITING
Dallas
Virginia
Sentara Norfolk General Hospital
RECRUITING
Norfolk
Washington
Providence Sacred Heart Med Center
RECRUITING
Spokane
Wisconsin
Aurora St. Luke's Medical Center
TERMINATED
Milwaukee
Other Locations
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Germany
Klinikum Hochsauerland GmbH
RECRUITING
Arnsberg
Universitätsklinikum Augsburg
RECRUITING
Augsburg
Charité - Universitätsmedizin Berlin
TERMINATED
Berlin
MVZ CCB Frankfurt und Main-Taunus GbR
RECRUITING
Frankfurt Am Main
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Universität Leipzig
RECRUITING
Leipzig
Universitätsklinikum Tübingen
RECRUITING
Tübingen
Switzerland
Kantonsspital Baden
RECRUITING
Baden
Inselspital, Universitätsspital Bern
RECRUITING
Bern
Luzerner Kantonsspital
RECRUITING
Lucerne
United Kingdom
GSST London/St Thomas
RECRUITING
London
Imperial College
RECRUITING
London
Freeman Hospital Newcastle upon Tyne
RECRUITING
Newcastle Upon Tyne
Oxford - John Radcliffe
RECRUITING
Oxford
Contact Information
Primary
Christine Wills
christine.wills@inarimedical.com
6027992920
Backup
Paul Dalecke
paul.dalecke@inarimedical.com
6154271835
Time Frame
Start Date: 2023-01-06
Estimated Completion Date: 2027-01-15
Participants
Target number of participants: 300
Treatments
Active_comparator: Interventional
Interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm).
Active_comparator: Conservative Medical Management
Conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm).
Related Therapeutic Areas
Sponsors
Leads: Inari Medical