RecruitingVenous ThromboembolismDeep Venous ThrombosisPost-Thrombotic Syndrome

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

Eligible age

18+ yrs

Accepts

All genders

Locations

26 states

Healthy volunteers

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About this study

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.

Sponsor: Inari Medical

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