Study to Compare MAGNITUDE Sirolimus-Eluting Bioresorbable Scaffold Versus Angioplasty for Treating Narrowed Below-the-Knee Arteries in Chronic Limb-Threatening Ischemia

What this Trial Is About

Researchers are studying the safety and effectiveness of the MAGNITUDE Bioresorbable Sirolimus-Eluting Scaffold BRS System for treating narrowed blood vessels below the knee in people with chronic limb-threatening ischemia. This randomized controlled trial will include about 276 participants who have specific artery blockages in the lower leg. The study aims to compare the MAGNITUDE BRS device with a standard procedure called Percutaneous Transluminal Angioplasty PTA. Participants will be randomly assigned to receive either the MAGNITUDE BRS device or the PTA procedure. Both treatments target narrowed infrapopliteal arteries, including vessels like the tibioperoneal trunk and tibial arteries. The trial includes careful criteria on lesion size, location, and vessel condition to ensure appropriate treatment. Researchers will follow participants to assess the safety and success of the procedures, focusing on limb health and vessel openness. During the study, participants will undergo follow-up visits including angiograms to monitor the treated blood vessels. Researchers will track major adverse limb events, peri-operative death within 30 days, limb salvage, and vessel patency over six months. Participants need to complete all scheduled visits and evaluations, which include clinical assessments and imaging. The study is planned to be conducted at up to 60 sites globally and will continue until March 2032.

Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease