Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05701917

DEFIANCE - ClotTriever Thrombectomy System versus Anticoagulation Alone for Treating Deep Vein Thrombosis

Led by Inari Medical · Updated on 2026-05-29

300

Participants Needed

64

Research Sites

28 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating treatments for symptomatic unilateral iliofemoral deep vein thrombosis (DVT), comparing the ClotTriever System, a mechanical thrombectomy device, to standard anticoagulation therapy. This prospective, multicenter, randomized controlled trial aims to understand which approach better achieves and maintains vessel openness, tracking clinical outcomes and patient details through six months. About 300 participants will be enrolled and randomly assigned to one of the two treatment groups. Participants in the ClotTriever Intervention Arm will receive the mechanical thrombectomy procedure using the ClotTriever System. Those in the Conservative Medical Management Arm will receive anticoagulation therapy alone, including approved drugs such as Heparin, Coumadin, Rivaroxaban, or Apixaban. The study involves two main treatment approaches, with monitoring continuing through the six-month follow-up period to assess treatment effects and safety. During the study, participants will undergo assessments to collect data on demographics, comorbidities, DVT diagnosis, and treatment details. Clinical outcomes will be measured at intervals up to 180 days, focusing on a composite clinical endpoint using a win ratio method and evaluating post-thrombotic syndrome severity. Follow-up visits will monitor health status, treatment adherence, and any complications. The total duration of participation will extend through the six-month post-treatment period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Proximal lower extremity unilateral deep vein thrombosis involving the common femoral, external iliac, or common iliac veins
  • Symptom onset within 12 weeks before enrollment
  • Significant symptoms with a Villalta score greater than 9
  • Willing and able to provide informed consent
Not Eligible

You will not qualify if you...

  • Bilateral iliofemoral deep vein thrombosis
  • Prior venous stent in the target venous segment
  • Congenital anatomic anomalies of the inferior vena cava or iliac veins such as IVC aplasia or hypoplasia
  • Presence of an IVC filter at enrollment
  • Limb-threatening circulatory compromise (e.g., phlegmasia)
  • Clot in transit including IVC thrombus extending more than 2 cm into the IVC from the common iliac vein
  • Symptomatic pulmonary embolism with right heart strain judged unsuitable for DVT intervention
  • Medical or technical reasons preventing intervention as judged by physician
  • Severe allergy or thrombocytopenia related to heparin
  • Severe allergy to iodinated contrast agents that cannot be managed
  • Hemoglobin less than 8.0 g/dL, INR over 1.7 before warfarin started, or platelets less than 50,000/µl that cannot be corrected
  • Severe renal impairment with estimated GFR less than 30 ml/min in non-dialysis patients
  • Inability to receive therapeutic anticoagulation
  • Uncontrolled severe hypertension (systolic > 180 mmHg or diastolic > 105 mmHg)
  • Recent DVT interventional procedure within 30 days
  • Participation in another interfering study
  • Life expectancy less than 6 months or non-ambulatory status
  • Unmanageable hypercoagulable states
  • Conditions judged by investigator to contraindicate participation or affect assessments
  • Previous completion or withdrawal from this study
  • Unwillingness or inability to follow up per protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 12 weeks or as determined by treatment needs

Participants in the ClotTriever Intervention Arm receive mechanical thrombectomy using the ClotTriever System to restore vessel patency. Participants in the Conservative Medical Management Arm receive anticoagulation therapy to manage deep vein thrombosis.

1 procedure visit plus regular follow-up visits during treatment

Follow-up

Duration - Up to 180 days (+-14 days)

Participants are monitored for clinical outcomes and severity of post-thrombotic syndrome after treatment completion.

Follow-up visits at approximately 10 days and 180 days post-treatment

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

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Research Team

K

Kevin Wilhelmi

S

Sara Willis

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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Published Research Related To This Trial

Rationale and design of the DEFIANCE study: A randomized controlled trial of mechanical thrombectomy versus anticoagulation alone for iliofemoral deep vein thrombosis.

Steven D Abramowitz, Xhorlina Marko, Donna D'Souza...

https://pubmed.ncbi.nlm.nih.gov/39491572