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

Recruiting now · Not applicable

Conditions studied: Venous Thromboembolism, Deep Venous Thrombosis, Post-Thrombotic Syndrome

In brief

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.

Key facts

Study ID

NCT05701917

Run by

Inari Medical

People needed

300

Starts

2023-01-06

Expected to finish

2028-07-31

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• NYU Langone Medical Center — New York, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Northwell Health — Bay Shore, New York, United States (enrolling)
• NYP-Brooklyn Methodist — Brooklyn, New York, United States (enrolling)
• UCI Medical Center — Orange, California, United States (enrolling)
• Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• Cooper University Hospital — Camden, New Jersey, United States (enrolling)
• Vascular and Interventional Specialists of Orange County — Orange, California, United States (enrolling)
• Baptist Health Research Institute — Jacksonville, Florida, United States (enrolling)
• Honor Health — Scottsdale, Arizona, United States (enrolling)
• University Of Colorado — Denver, Colorado, United States (enrolling)
• Sarasota Memorial Hospital — Sarasota, Florida, United States (enrolling)
• BayCare Health System — Tampa, Florida, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• MedStar Health Research Institution — Washington D.C., District of Columbia, United States (enrolling)
• Pima Heart and Vascular — Tucson, Arizona, United States (enrolling)
• University of Maryland — Baltimore, Maryland, United States (enrolling)
• McLaren Healthcare — Bay City, Michigan, United States (enrolling)
• Henry Ford Health — Detroit, Michigan, United States (enrolling)
• MyMichigan Medical Center — Midland, Michigan, United States (enrolling)
• University of Missouri — Columbia, Missouri, United States (enrolling)
• Huntington Health — Pasadena, California, United States (enrolling)
• St. Louis University — St Louis, Missouri, United States (enrolling)
• University Medical Center of Southern Nevada — Las Vegas, Nevada, United States (enrolling)
• Saint Francis Hospital — Tulsa, Oklahoma, United States (enrolling)

Full record on ClinicalTrials.gov

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