Actively Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Led by Inari Medical · Updated on 2026-05-01
300
Participants Needed
64
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Proximal lower extremity unilateral DVT involving at least the common femoral, external iliac, or common iliac veins
- Symptom onset within 12 weeks of enrollment
- Significant symptoms defined by a Villalta score greater than 9
- Willing and able to provide informed consent
You will not qualify if you...
- Bilateral iliofemoral DVT
- Prior venous stent in the target venous segment
- Congenital anomalies of the inferior vena cava (IVC) or iliac veins such as aplasia or hypoplasia
- IVC filter present at enrollment
- Limb-threatening circulatory compromise (e.g., phlegmasia)
- Clot in transit including IVC thrombus extending more than 2cm into the IVC from the common iliac vein
- Symptomatic pulmonary embolism with right heart strain considered inappropriate for DVT intervention
- Medical or technical reasons preventing intervention as judged by a physician
- Severe allergy or low platelet count related to heparin
- Severe allergy to iodinated contrast agents that cannot be managed
- Hemoglobin less than 8.0 g/dL, INR above 1.7 before warfarin initiation, or platelets below 50,000/µl that cannot be corrected
- Severe renal impairment (eGFR less than 30 ml/min) in non-dialysis patients
- Inability to receive therapeutic anticoagulation as decided by the investigator
- Uncontrolled severe hypertension (systolic > 180 mmHg or diastolic > 105 mmHg)
- Recent (within 30 days) DVT interventional procedure
- Participation in another interfering study
- Life expectancy under 6 months or chronic non-ambulatory status
- Known hypercoagulable states that cannot be medically managed during the study
- Any condition deemed by the investigator to make participation unsafe or unsuitable
- Previous completion or withdrawal from this study
- Unwillingness or inability to attend follow-up visits as required
AI-Screening
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Trial Site Locations
Total: 64 locations
1
Honor Health
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Pima Heart and Vascular
Tucson, Arizona, United States, 85704
Actively Recruiting
3
UCI Medical Center
Orange, California, United States, 92868
Actively Recruiting
4
Vascular and Interventional Specialists of Orange County
Orange, California, United States, 92868
Actively Recruiting
5
Huntington Health
Pasadena, California, United States, 91105
Actively Recruiting
6
University Of Colorado
Denver, Colorado, United States, 80045
Actively Recruiting
7
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
8
MedStar Health Research Institution
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
9
Manatee Memorial Hospital
Bradenton, Florida, United States, 34208
Terminated
10
Baptist Health Research Institute
Jacksonville, Florida, United States, 32207
Actively Recruiting
11
Lakeland Vascular Institute
Lakeland, Florida, United States, 33805
Terminated
12
HCA Florida Largo Hospital
Largo, Florida, United States, 33770
Actively Recruiting
13
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Actively Recruiting
14
BayCare Health System
Tampa, Florida, United States, 33607
Actively Recruiting
15
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Terminated
16
Community Healthcare System
Munster, Indiana, United States, 46321
Terminated
17
St. Elizabeth Edgewood
Edgewood, Kentucky, United States, 41017
Terminated
18
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
19
McLaren Healthcare
Bay City, Michigan, United States, 48708
Actively Recruiting
20
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
21
MyMichigan Medical Center
Midland, Michigan, United States, 48670
Actively Recruiting
22
University of Missouri
Columbia, Missouri, United States, 65212
Actively Recruiting
23
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64131
Terminated
24
St. Louis University
St Louis, Missouri, United States, 63104
Actively Recruiting
25
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Actively Recruiting
26
Cooper University Hospital
Camden, New Jersey, United States, 08103
Actively Recruiting
27
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
Terminated
28
Northwell Health
Bay Shore, New York, United States, 11706
Actively Recruiting
29
NYP-Brooklyn Methodist
Brooklyn, New York, United States, 11215
Actively Recruiting
30
SUNY, The University at Buffalo
Buffalo, New York, United States, 14203
Terminated
31
NYU Langone Medical Center
New York, New York, United States, 10016
Actively Recruiting
32
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
33
Mission Health
Asheville, North Carolina, United States, 28801
Terminated
34
Mercy Health - The Heart Institute
Cincinnati, Ohio, United States, 45211
Terminated
35
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
36
Saint Francis Hospital
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
37
Allegheny St. Vincent Hospital
Erie, Pennsylvania, United States, 16544
Actively Recruiting
38
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
39
Allegheny General Health Research Network
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
40
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
41
Prisma Health Upstate
Greenville, South Carolina, United States, 29615
Terminated
42
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
43
Lexington Medical Center
West Columbia, South Carolina, United States, 29169
Terminated
44
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
45
Clements University Hospital (UTSW)
Dallas, Texas, United States, 75390
Actively Recruiting
46
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
47
Providence Sacred Heart Med Center
Spokane, Washington, United States, 99204
Terminated
48
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Terminated
49
Vienna General Hospital (AKH Wien)
Vienna, Austria
Actively Recruiting
50
Helsinki University Hospital
Helsinki, Finland
Actively Recruiting
51
Universitätsklinikum Tübingen
Tübingen, Baden-Würtemberg, Germany, 72076
Actively Recruiting
52
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt am Main, Hesse, Germany, 60389
Actively Recruiting
53
Klinikum Hochsauerland GmbH
Arnsberg, North Rhine-Westphalia, Germany, 59759
Actively Recruiting
54
Universität Leipzig
Leipzig, Saxony, Germany, 04109
Actively Recruiting
55
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 10117
Terminated
56
Universitätsklinikum Augsburg
Augsburg, Germany
Actively Recruiting
57
Universitätsklinikum Heidelberg
Heidelberg, Germany
Actively Recruiting
58
Kantonsspital Baden
Baden, Switzerland
Actively Recruiting
59
Inselspital, Universitätsspital Bern
Bern, Switzerland
Actively Recruiting
60
Luzerner Kantonsspital
Lucerne, Switzerland
Actively Recruiting
61
GSST London/St Thomas
London, United Kingdom
Actively Recruiting
62
Imperial College
London, United Kingdom
Actively Recruiting
63
Freeman Hospital Newcastle upon Tyne
Newcastle upon Tyne, United Kingdom
Actively Recruiting
64
Oxford - John Radcliffe
Oxford, United Kingdom
Actively Recruiting
Research Team
K
Kevin Wilhelmi
CONTACT
S
Sara Willis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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