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Comparison of ClotTriever System and Anticoagulation for Deep Vein Thrombosis

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

NA · Inari Medical · NCT05701917

This study is testing if the ClotTriever System can help people with painful deep vein blood clots feel better compared to the usual blood-thinning medications.

Quick facts

PhaseNA
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorInari Medical (industry)
Locations64 sites (Scottsdale, Arizona and 63 other locations)
Trial IDNCT05701917 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the ClotTriever System in treating symptomatic unilateral iliofemoral deep vein thrombosis (DVT) compared to standard anticoagulation therapy. It is a multicenter, randomized controlled trial that will enroll up to 300 participants who meet specific inclusion criteria. Participants will be randomly assigned to either the ClotTriever Intervention Arm or the Conservative Medical Management Arm, and their clinical outcomes will be monitored over a six-month follow-up period. Data collected will include demographics, comorbidities, and details regarding DVT diagnosis and treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 years and older with symptomatic unilateral iliofemoral DVT and significant symptoms.

Not a fit: Patients with bilateral DVT, prior venous stents, or other significant medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with symptomatic DVT, potentially improving their clinical outcomes.

How similar studies have performed: While the ClotTriever System represents a novel approach, similar interventional strategies have shown promise in treating DVT, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Scottsdale, Arizona and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Venous Thromboembolism, Deep Venous Thrombosis, Post-Thrombotic Syndrome, Anticoagulation, Percutaneous Mechanical Thrombectomy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.