Safety and Effectiveness Study of Renzan Peripheral Stent in Treating Femoro-Popliteal Artery Disease in Tuscany

What this Trial Is About

Researchers are investigating the safety and effectiveness of the Renzan14 Peripheral Stent System in treating patients with femoro-popliteal disease, a type of peripheral arterial disease affecting the leg arteries. This prospective, multicenter, single-arm study plans to include about 100 patients eligible for treatment with this stent. The study focuses on evaluating a modern nitinol stent designed for complex lesions where drug-coated balloons and drug-eluting stents may be less effective or raise concerns about toxicity. The Renzan stent is a self-expanding nitinol device pre-mounted on a catheter designed for precise placement in the affected arteries. It consists of two layers of braided nitinol wire mesh with radiopaque markers to assist in positioning during the procedure. The stent can be partly recaptured during placement if needed. This study observes patients undergoing endovascular implantation of the Renzan stent without comparison groups, focusing on the devices performance and safety after treatment. Participants will be followed for assessments of safety and effectiveness, including measurements at 30 days and up to 12 months after the procedure. Key evaluations include device and procedural success during implantation, rates of death, need for further treatment of the treated artery, artery openness, limb ischemia improvement, major adverse events, and limb amputation at multiple time points up to 36 months. Patients will be monitored closely with follow-up visits to track these outcomes and the long-term performance of the stent.

A ProspeCtive mUlticenteR Investigation on RENzar Stent Safety and Efficacy in the Treatment of Patients With Femoro-popliteal Disease in Tuscany (CURRENT Registry)