Study of the MAGNITUDE Bioresorbable Drug-Eluting Scaffold to Treat Narrowed Below-the-Knee Arteries in Adults in Australia

What this Trial Is About

Researchers are evaluating the MAGNITUDE Bioresorbable Drug-Eluting Scaffold System to treat narrowed infrapopliteal arteries in patients with critical limb-threatening ischemia. This prospective, multi-center clinical investigation aims to assess this devices safety and effectiveness for below-the-knee disease. The study will enroll up to 30 participants across three clinical sites in Australia to better understand its potential role in treating these vascular conditions. Participants will receive treatment with the MAGNITUDE Scaffold device targeting lesions in infrapopliteal vessels such as the tibioperoneal trunk, anterior tibial artery, posterior tibial artery, or peroneal artery. The study includes detailed angiographic criteria for lesion location, size, and vessel characteristics. Treatment focuses on lesions with specific vessel diameters and stenosis levels, with up to two target lesions treated per participant. Follow-up includes angiograms and clinical evaluations to monitor vessel patency and limb salvage. During the study, participants will undergo protocol-required follow-up visits including angiograms at specified intervals. Researchers will monitor safety outcomes such as freedom from major adverse limb events and peri-operative death at 30 days and 6 months, as well as efficacy outcomes including composite limb salvage and primary vessel patency at 6 months. The total participation duration and ongoing safety monitoring aim to capture the devices performance and participant outcomes comprehensively.

Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia