Evaluating Sperstent and Everflex Stent Systems for Treating Residual Lesions in Femoropopliteal Arteries After Balloon Angioplasty

What this Trial Is About

Researchers are conducting a prospective, multicenter, randomized trial to assess the effectiveness and safety of the Sperstent peripheral spot stent system compared to the Everflex self-expanding peripheral stent system. The study focuses on treating residual lesions such as stenoses and dissections that remain after balloon angioplasty in the femoral and proximal popliteal arteries. These conditions are common in patients with peripheral arterial disease and affect blood flow in the legs. Participants will receive either the Sperstent peripheral spot stent system or the Everflex self-expanding peripheral stent system during endovascular treatment following percutaneous transluminal angioplasty PTA. Both treatments involve placing a stent to open narrowed or blocked arteries, guided by digital subtraction angiography DSA. The trial compares these two devices to understand their impact on artery patency and safety over time. Throughout the study, participants will be closely monitored with follow-up assessments including imaging to check artery openness, clinical evaluations of symptoms using Rutherford classification and ankle-brachial index ABI, and tracking of major adverse events. Key outcomes include primary patency at 12 months and freedom from major adverse events at 30 days after the procedure. The study period includes evaluations immediately after treatment and at 30 days, 6 months, and 12 months to monitor device success, procedural success, and changes in clinical status.

A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries