DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis
Inari Medical
Summary
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.
Description
The study will compare the clinical outcomes of patients treated with 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 symptomatic unilateral iliofemoral DVT. Approximately 300 subjects will be enrolled and randomized. All subjects who sign informed consent and who meet all of the inclusion criteria and none of the exclusion criteria will be randomized (1:1, ClotTriever Intervention Arm…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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-threateni…
Interventions
- DeviceClotTriever System
Mechanical thrombectomy
- DrugCommercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Anticoagulants are a group of medications that decrease your blood's ability to clot.
Locations (64)
- Honor HealthScottsdale, Arizona
- Pima Heart and VascularTucson, Arizona
- UCI Medical CenterOrange, California
- Vascular and Interventional Specialists of Orange CountyOrange, California
- Huntington HealthPasadena, California
- University Of ColoradoDenver, Colorado