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

May 27, 2026 updated by: Inari Medical

DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria
        • Recruiting
        • Vienna General Hospital (AKH Wien)
        • Contact:
          • Oliver Schlager, Dr. med
  • Finland
      • Helsinki, Finland
        • Recruiting
        • Helsinki University Hospital
        • Contact:
          • Matti Laine, MD, PhD
  • Germany
      • Augsburg, Germany
        • Recruiting
        • Universitätsklinikum Augsburg
        • Contact:
          • Christian Scheurig-Münkler, PD Dr.
      • Heidelberg, Germany
        • Recruiting
        • Universitätsklinikum Heidelberg
        • Contact:
          • Christian Erbel, Prof. Dr.
    • Baden-Würtemberg
      • Tübingen, Baden-Würtemberg, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen
        • Contact:
          • Gerd Grözinger, Dr. med.
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60389
        • Recruiting
        • MVZ CCB Frankfurt und Main-Taunus GbR
        • Contact:
          • Michael Piorkowski, Dr. med.
    • North Rhine-Westphalia
      • Arnsberg, North Rhine-Westphalia, Germany, 59759
        • Recruiting
        • Klinikum Hochsauerland GmbH
        • Contact:
          • Michael Lichtenberg, MD
    • Saxony
      • Leipzig, Saxony, Germany, 04109
        • Recruiting
        • Universität Leipzig
        • Contact:
          • Andrej Schmidt, Prof Dr med
    • State of Berlin
      • Berlin, State of Berlin, Germany, 10117
        • Terminated
        • Charité - Universitätsmedizin Berlin
  • Switzerland
      • Baden, Switzerland
        • Recruiting
        • Kantonsspital Baden
        • Contact:
          • Michael Kostrzewa, Dr.
      • Bern, Switzerland
        • Recruiting
        • Inselspital, Universitätsspital Bern
        • Contact:
          • Marc Schindewolf, Dr. med.
      • Lucerne, Switzerland
        • Recruiting
        • Luzerner Kantonsspital
        • Contact:
          • Thorsten Grumann, Dr. med.
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Imperial College
        • Contact:
          • Alun H Davies, Prof.
      • London, United Kingdom
        • Recruiting
        • GSST London/St Thomas
        • Contact:
          • Taha Khan, Mr
      • Newcastle upon Tyne, United Kingdom
        • Recruiting
        • Freeman Hospital Newcastle upon Tyne
        • Contact:
          • Sandip Nandhra, Dr.
      • Oxford, United Kingdom
        • Recruiting
        • Oxford - John Radcliffe
        • Contact:
          • Andrew Wigham, Dr
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honor Health
        • Contact:
          • Venkataramanan Gangadharan, MD
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Pima Heart and Vascular
        • Contact:
          • Joseph Sabat, MD
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • UCI Medical Center
        • Contact:
          • Anthony H Chau, MD
      • Orange, California, United States, 92868
        • Recruiting
        • Vascular and Interventional Specialists of Orange County
        • Contact:
          • Theodore Bryan, MD
      • Pasadena, California, United States, 91105
        • Recruiting
        • Huntington Health
        • Contact:
          • Theodore Teruya, MD
    • Colorado
      • Denver, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
          • Jonathan D Lindquist, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
          • Hamid R Mojibian, MD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Health Research Institution
        • Contact:
          • Saher S Sabri, MD
    • Florida
      • Bradenton, Florida, United States, 34208
        • Terminated
        • Manatee Memorial Hospital
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Health Research Institute
        • Contact:
          • Bharat Gummadi, MD
      • Lakeland, Florida, United States, 33805
        • Terminated
        • Lakeland Vascular Institute
      • Largo, Florida, United States, 33770
        • Recruiting
        • HCA Florida Largo Hospital
        • Contact:
          • Jesse Klein, DO
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Hospital
        • Contact:
          • Juan C Camacho-Vasquez, MD
      • Tampa, Florida, United States, 33607
        • Recruiting
        • BayCare Health System
        • Contact:
          • Nicholas Turman, MD
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Terminated
        • Memorial Health University Medical Center
    • Indiana
      • Munster, Indiana, United States, 46321
        • Terminated
        • Community Healthcare System
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Terminated
        • St. Elizabeth Edgewood
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Contact:
          • Khanjan Nagarsheth, MD
    • Michigan
      • Bay City, Michigan, United States, 48708
        • Recruiting
        • McLaren Healthcare
        • Contact:
          • Nicolas Mouawad, MD
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Contact:
          • Scott Kaatz, MD
      • Midland, Michigan, United States, 48670
        • Recruiting
        • MyMichigan Medical Center
        • Contact:
          • Contantinos Constantinou, MD
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri
        • Contact:
          • Ambarish Bhat, MD
      • Kansas City, Missouri, United States, 64131
        • Terminated
        • Saint Luke's Hospital of Kansas City
      • St Louis, Missouri, United States, 63104
        • Recruiting
        • St. Louis University
        • Contact:
          • Keith Pereira, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • University Medical Center of Southern Nevada
        • Contact:
          • Ryan Rimer, MD
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper University Hospital
        • Contact:
          • Laurel Hastings, MD
      • Teaneck, New Jersey, United States, 07666
        • Terminated
        • Holy Name Medical Center
    • New York
      • Bay Shore, New York, United States, 11706
        • Recruiting
        • Northwell Health
        • Contact:
          • Jonathan A Schor, MD
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • NYP-Brooklyn Methodist
        • Contact:
          • Rajesh K Malik, MD
      • Buffalo, New York, United States, 14203
        • Terminated
        • SUNY, The University at Buffalo
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
          • Edvard Skripochnik, MD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Medical Center
        • Contact:
          • Katherine Teter, MD
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Terminated
        • Mission Health
    • Ohio
      • Cincinnati, Ohio, United States, 45211
        • Terminated
        • Mercy Health - The Heart Institute
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Aravinda Nanjundappa, MD
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Saint Francis Hospital
        • Contact:
          • Tucker J Harrison, DO
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16544
        • Recruiting
        • Allegheny St. Vincent Hospital
        • Contact:
          • Orestis Pappas, MD
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Contact:
          • Robert W Ford, MD
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Health Research Network
        • Contact:
          • Abdullah A Shaikh, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
          • John Lee, MD
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Terminated
        • Prisma Health Upstate
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Contact:
          • Brian J Brown, MD
      • West Columbia, South Carolina, United States, 29169
        • Terminated
        • Lexington Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Mark D Iafrati, MD
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • Clements University Hospital (UTSW)
        • Contact:
          • Michael C Siah, MD
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Hospital
        • Contact:
          • David J Dexter, MD
    • Washington
      • Spokane, Washington, United States, 99204
        • Terminated
        • Providence Sacred Heart Med Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Terminated
        • Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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

Exclusion Criteria

  • Bilateral iliofemoral DVT
  • Prior venous stent in the target venous segment
  • IVC aplasia/hypoplasia or other congenital anatomic anomalies of the IVC or iliac veins
  • IVC filter in place at the time of enrollment
  • Limb-threatening circulatory compromise (e.g., phlegmasia)
  • Clot in transit including IVC thrombus presenting as extension of >2cm into the IVC from the CIV
  • Symptomatic PE with right heart strain where the physician judges that a DVT intervention is inappropriate at this time.
  • Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement
  • Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
  • Severe allergy to iodinated contrast agents that cannot be mitigated
  • Hemoglobin < 8.0 g/dL, INR > 1.7 before warfarin was started, or platelets < 50,000/µl which cannot be corrected prior to enrollment
  • Severe renal impairment (estimated GFR < 30 ml/min) in patients who are not yet on dialysis
  • Inability to provide therapeutic anticoagulation per Investigator discretion
  • Uncontrolled severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105mmHg)
  • Recently (< 30 days) had DVT interventional procedure
  • Subject is participating in another study that may interfere with this study
  • Life expectancy < 6 months or chronic non-ambulatory status
  • Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period
  • Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (e.g., contraindication to use of ClotTriever per local approved labeling, compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments)
  • Subject has previously completed or withdrawn from this study
  • Patient unwilling or unable to conduct the follow up visits per protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interventional
Interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm).
Device: ClotTriever System
Mechanical thrombectomy
Active Comparator: Conservative Medical Management
Conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm).
Drug: Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Anticoagulants are a group of medications that decrease your blood's ability to clot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:
Time Frame: 180 Days (+-14 Days)
  1. Occurrence of treatment failure or therapy escalation
  2. Assessment of PTS severity, as defined by the Villalta scale
180 Days (+-14 Days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:
Time Frame: 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
10 Days (+- 3 Days)
Assessment of PTS Severity:
Time Frame: 180 Days (+-14 Days)
a. Assessment of PTS severity, as defined by the Villalta scale
180 Days (+-14 Days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inari Medical

Investigators

  • Principal Investigator: Steven Abramowitz, MD, MedStar Health Research Institution
  • Principal Investigator: Stephen Black, MD, St Thomas' Hospital (UK)
  • Principal Investigator: Xhorlina Marko, MD, Henry Ford Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

January 15, 2027

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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