DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Recruiting
N/A
Interventional Study
Venous Thromboembolism
Deep Venous Thrombosis
Post-Thrombotic Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- Inari Medical · Industry
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About This Trial
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…
Trial Locations
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Eligibility 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
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Contacts