Evaluating Safety and Effectiveness of a Peripheral Thrombectomy Device for Adult Lower Extremity Deep Vein Thrombosis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a peripheral thrombectomy system for treating lower extremity deep vein thrombosis DVT in adults. The study plans to enroll 167 participants diagnosed with acute or subacute iliofemoral or femoropopliteal DVT. The goal is to assess the technical success and clinical outcomes of this device-based treatment. Participants will receive treatment using the BM peripheral thrombectomy system, which is designed to remove blood clots from the veins in the lower limbs. All participants will be treated with this device as part of a single study group. Treatment details and patient outcomes will be documented throughout the trial. The study involves follow-up assessments at screening, on the day of the procedure, before hospital discharge, and at 1, 3, and 6 months after treatment. Researchers will measure technical success immediately after the procedure and monitor safety through adverse event rates and clinical scores such as the Venous Clinical Severity Score VCSS. Vein patency and incidence of post-thrombotic syndrome will also be evaluated up to 6 months post-procedure.

Clinical Trial of Thrombectomy Systems