Comparison of ClotTriever System Device Versus Anticoagulation Therapy for Symptomatic Unilateral Iliofemoral Deep Vein Thrombosis A Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the use of the ClotTriever System compared to standard anticoagulation therapy for treating symptomatic unilateral iliofemoral deep vein thrombosis DVT. This trial is a prospective, multicenter, randomized controlled study that aims to compare clinical outcomes between an interventional device strategy and conservative medical management. The study will enroll approximately 300 participants and collect detailed data on demographics, comorbidities, DVT diagnosis, treatment, and clinical outcomes through a six-month follow-up. Participants will be randomly assigned to one of two groups the ClotTriever Intervention Arm, where the ClotTriever System device is used for mechanical thrombectomy to restore and maintain vessel openness, or the Conservative Medical Management Arm, where patients receive anticoagulation therapy alone with medications such as heparin, warfarin, rivaroxaban, or apixaban. The study compares these two approaches to determine their effects on treatment outcomes in symptomatic unilateral iliofemoral DVT. During the study, participants will undergo assessments including clinical evaluations at specified time points up to 180 days to measure a composite clinical endpoint using a win ratio method. Additional evaluations will include assessment of post-thrombotic syndrome severity and monitoring for safety and treatment effects. Participants must be willing and able to attend follow-up visits over the six-month period to provide data for the studys outcome measures.

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