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DEFIANCE: ClotTriever System vs. Anticoagulation for Deep Vein Thrombosis

This study is comparing two ways to treat deep vein thrombosis (DVT), which is a blood clot in a deep vein. You might be eligible if you are at least 18 years old and have a DVT in a large vein in your leg that started within the last 12 weeks and is causing significant symptoms. The study is testing the ClotTriever System, a device that removes blood clots, against standard blood-thinning medications like Heparin Sodium, Coumadin, Rivaroxaban, or Apixaban. Researchers will look at how well each treatment works to improve your symptoms and prevent future problems over 6 months. The study aims to enroll about 300 participants.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to one of two treatment groups. Approximately 300 people will participate in this study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 180 days (about 6 months) after treatment to assess their clinical outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05701917

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

Recruiting
NAAges 18+InterventionalTreatment
Inari Medical
~300 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:ClotTriever SystemCommercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.

At a glance

Recruiting sites
48 of 64 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:
Measured over 180 Days (+-14 Days)

Conditions

Venous Thromboembolism
Deep Venous Thrombosis
Post-Thrombotic Syndrome

Explore related trials

Deep Vein Thrombosis

NCT05701917

Where you'd take part

This study runs at 64 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Allegheny General Health Research Network

    Pittsburgh, Pennsylvaniano site contact published

    Recruiting

  • Allegheny St. Vincent Hospital

    Erie, Pennsylvaniano site contact published

    Recruiting

  • Baptist Health Research Institute

    Jacksonville, Floridano site contact published

    Recruiting

  • BayCare Health System

    Tampa, Floridano site contact published

    Recruiting

  • Clements University Hospital (UTSW)

    Dallas, Texasno site contact published

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohiono site contact published

    Recruiting

  • Columbia University Irving Medical Center

    New York, New Yorkno site contact published

    Recruiting

  • Cooper University Hospital

    Camden, New Jerseyno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Mark Sung
[email protected]
949-466-9458
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Composite clinical endpoint constructed as a win ratio, a hierarchy of the following:180 Days (+-14 Days)

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