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Venous ThromboembolismDEFIANCENCT05701917

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

A study testing ClotTriever System and Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. in people with Venous Thromboembolism and Deep Venous Thrombosis, run by Inari Medical at 64 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ClotTriever System and Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
64 sitesin 6 countries
Study dates
6 Jan 2023to 31 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

64 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Mark Sung contact

949-466-9458

mark.sung@stryker.com

Sara Willis contact

sara.willis@stryker.com

64 sites in 6 countries

United States48 sites, 33 recruiting

  • Mission Health

    Asheville, North Carolina, 28801

    Terminated

  • University of Maryland

    Baltimore, Maryland, 21201

    Khanjan Nagarsheth, MD

    Recruiting

  • McLaren Healthcare

    Bay City, Michigan, 48708

    Nicolas Mouawad, MD

    Recruiting

  • Northwell Health

    Bay Shore, New York, 11706

    Jonathan A Schor, MD

    Recruiting

  • Manatee Memorial Hospital

    Bradenton, Florida, 34208

    Terminated

  • NYP-Brooklyn Methodist

    Brooklyn, New York, 11215

    Rajesh K Malik, MD

    Recruiting

  • SUNY, The University at Buffalo

    Buffalo, New York, 14203

    Terminated

  • Cooper University Hospital

    Camden, New Jersey, 08103

    Laurel Hastings, MD

    Recruiting

  • Mercy Health - The Heart Institute

    Cincinnati, Ohio, 45211

    Terminated

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Aravinda Nanjundappa, MD

    Recruiting

  • University of Missouri

    Columbia, Missouri, 65212

    Ambarish Bhat, MD

    Recruiting

  • Clements University Hospital (UTSW)

    Dallas, Texas, 75390

    Michael C Siah, MD

    Recruiting

  • University Of Colorado

    Denver, Colorado, 80045

    Jonathan D Lindquist, MD

    Recruiting

  • Henry Ford Health

    Detroit, Michigan, 48202

    Scott Kaatz, MD

    Recruiting

  • St. Elizabeth Edgewood

    Edgewood, Kentucky, 41017

    Terminated

  • Allegheny St. Vincent Hospital

    Erie, Pennsylvania, 16544

    Orestis Pappas, MD

    Recruiting

  • Prisma Health Upstate

    Greenville, South Carolina, 29615

    Terminated

  • Baptist Health Research Institute

    Jacksonville, Florida, 32207

    Bharat Gummadi, MD

    Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64131

    Terminated

  • Lakeland Vascular Institute

    Lakeland, Florida, 33805

    Terminated

  • HCA Florida Largo Hospital

    Largo, Florida, 33770

    Terminated

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

    Ryan Rimer, MD

    Recruiting

  • MyMichigan Medical Center

    Midland, Michigan, 48670

    Contantinos Constantinou, MD

    Recruiting

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Terminated

  • Community Healthcare System

    Munster, Indiana, 46321

    Terminated

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Mark D Iafrati, MD

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Hamid R Mojibian, MD

    Recruiting

  • NYU Langone Medical Center

    New York, New York, 10016

    Katherine Teter, MD

    Recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Edvard Skripochnik, MD

    Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

    David J Dexter, MD

    Recruiting

  • UCI Medical Center

    Orange, California, 92868

    Anthony H Chau, MD

    Recruiting

  • Vascular and Interventional Specialists of Orange County

    Orange, California, 92868

    Theodore Bryan, MD

    Recruiting

  • Huntington Health

    Pasadena, California, 91105

    Theodore Teruya, MD

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Robert W Ford, MD

    Recruiting

  • Allegheny General Health Research Network

    Pittsburgh, Pennsylvania, 15212

    Abdullah A Shaikh, MD

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    John Lee, MD

    Recruiting

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

    Juan C Camacho-Vasquez, MD

    Recruiting

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

    Terminated

  • Honor Health

    Scottsdale, Arizona, 85258

    Venkataramanan Gangadharan, MD

    Recruiting

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

    Brian J Brown, MD

    Recruiting

  • Providence Sacred Heart Med Center

    Spokane, Washington, 99204

    Terminated

  • St. Louis University

    St Louis, Missouri, 63104

    Keith Pereira, MD

    Recruiting

  • BayCare Health System

    Tampa, Florida, 33607

    Nicholas Turman, MD

    Recruiting

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

    Terminated

  • Pima Heart and Vascular

    Tucson, Arizona, 85704

    Joseph Sabat, MD

    Recruiting

  • Saint Francis Hospital

    Tulsa, Oklahoma, 74136

    Tucker J Harrison, DO

    Recruiting

  • MedStar Health Research Institution

    Washington D.C., District of Columbia, 20010

    Saher S Sabri, MD

    Recruiting

  • Lexington Medical Center

    West Columbia, South Carolina, 29169

    Terminated

Other trials in United States

Germany7 sites, 6 recruiting

  • Klinikum Hochsauerland GmbH

    Arnsberg, North Rhine-Westphalia, 59759

    Michael Lichtenberg, MD

    Recruiting

  • Universitätsklinikum Augsburg

    Augsburg

    Christian Scheurig-Münkler, PD Dr.

    Recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, State of Berlin, 10117

    Terminated

  • MVZ CCB Frankfurt und Main-Taunus GbR

    Frankfurt am Main, Hesse, 60389

    Michael Piorkowski, Dr. med.

    Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg

    Christian Erbel, Prof. Dr.

    Recruiting

  • Universität Leipzig

    Leipzig, Saxony, 04109

    Andrej Schmidt, Prof Dr med

    Recruiting

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Würtemberg, 72076

    Gerd Grözinger, Dr. med.

    Recruiting

Other trials in Germany

United Kingdom4 sites, 4 recruiting

  • GSST London/St Thomas

    London

    Taha Khan, Mr

    Recruiting

  • Imperial College

    London

    Alun H Davies, Prof.

    Recruiting

  • Freeman Hospital Newcastle upon Tyne

    Newcastle upon Tyne

    Sandip Nandhra, Dr.

    Recruiting

  • Oxford - John Radcliffe

    Oxford

    Andrew Wigham, Dr

    Recruiting

Other trials in United Kingdom

Switzerland3 sites, 3 recruiting

  • Kantonsspital Baden

    Baden

    Michael Kostrzewa, Dr.

    Recruiting

  • Inselspital, Universitätsspital Bern

    Bern

    Marc Schindewolf, Dr. med.

    Recruiting

  • Luzerner Kantonsspital

    Lucerne

    Thorsten Grumann, Dr. med.

    Recruiting

Other trials in Switzerland

Austria1 site, 1 recruiting

  • Vienna General Hospital (AKH Wien)

    Vienna

    Oliver Schlager, Dr. med

    Recruiting

Other trials in Austria

Finland1 site, 1 recruiting

  • Helsinki University Hospital

    Helsinki

    Matti Laine, MD, PhD

    Recruiting

Other trials in Finland

About this study

Official title: 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.

Read the 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).

Being tested
ClotTriever System, Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Keywords
Venous Thromboembolism, Deep Venous Thrombosis, Post-Thrombotic Syndrome, Anticoagulation, Percutaneous Mechanical Thrombectomy
Medical subject headings
Venous Thromboembolism, Venous Thrombosis, Postthrombotic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClotTriever SystemDevice

    Mechanical thrombectomy

  • Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.Drug

    Anticoagulants are a group of medications that decrease your blood's ability to clot.

Study groups in NCT05701917
Study groupRoleWhat they receive
InterventionalActive comparatorInterventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm).
Receives: Device: ClotTriever System
Conservative Medical ManagementActive comparatorConservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm).
Receives: Drug: Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:

    1. Occurrence of treatment failure or therapy escalation
    2. Assessment of PTS severity, as defined by the Villalta scale

    Measured: 180 Days (+-14 Days)

Secondary outcomes (2)

  1. Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:

    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

    Measured: 10 Days (+- 3 Days)

  2. Assessment of PTS Severity:

    1. Assessment of PTS severity, as defined by the Villalta scale

    Measured: 180 Days (+-14 Days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start6 Jan 2023
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05701917
Sponsor's protocol ID
22-001
Acronym
DEFIANCE
Status last verified
Oct 2026
First submitted
6 Jan 2023
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Abramowitz SD, Marko X, D'Souza D, Noor S, Pereira K, Silver MJ, Rosenberg SP, Markovitz CD, Tu T, Weinberg I, Black S. Rationale and design of the DEFIANCE study: A randomized controlled trial of mechanical thrombectomy versus anticoagulation alone for iliofemoral deep vein thrombosis. Am Heart J. 2025 Mar;281:92-102. doi: 10.1016/j.ahj.2024.10.016. Epub 2024 Nov 3.

    PubMed 39491572

  • Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.

    PubMed 39968829

Questions about this trial

What is this clinical trial studying?

A study testing ClotTriever System and Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. in people with Venous Thromboembolism and Deep Venous Thrombosis, run by Inari Medical at 64 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Germany, United Kingdom, Switzerland, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mark Sung (949-466-9458, mark.sung@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: (time frame: 180 Days (+-14 Days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05701917, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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