Study of the Efemoral Vascular Scaffold System EVSS to Treat Symptomatic Peripheral Vascular Disease Caused by Narrowing or Blockage in the Femoropopliteal Artery

What this Trial Is About

This research aims to evaluate the safety and performance of the Efemoral Vascular Scaffold System EVSS in patients who have symptomatic peripheral vascular disease caused by narrowing or blockage of the femoropopliteal artery. The study focuses on patients with artery diameters between 5.5 mm and 6.5 mm and lesion lengths up to 90 mm. It is a prospective, single-arm, open-label, multi-center clinical investigation. Participants will receive a single EVSS device, which is a balloon-expandable, bioresorbable vascular scaffold coated with sirolimus. The device is designed to be placed in the affected artery to treat the narrowing or blockage. The study does not include comparison groups and evaluates the devices performance over time. During the study, participants will undergo assessments at various time points up to 36 months. These include evaluations of major adverse events within 30 days, freedom from artery narrowing at 12 months, and measurements of device success immediately after the procedure. Additional follow-ups will monitor artery openness, revascularization needs, limb salvage, walking ability, and clinical success. Safety and technical success will also be tracked throughout the study period.

The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery