DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInari Medical
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 collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ClotTriever System
- Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov