Peripheral Artery Disease Clinical Trial
Official title:
Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment
Prospective, multicenter, randomized clinical trial, Follow-up at 1-, 6- and 12 months
This clinical investigation is first of all designed to demonstrate the safety and
effectiveness of the MAGIC EXPLORER stent system. The primary objectives of the study are to
evaluate the safety and 6-month patency of the bioabsorbable MAGIC EXPLORER stent in
patients with stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries.
Secondary endpoints are the procedural success, patency at all follow-ups, late lumen loss
and limb-salvage rate. Peri-procedural complications (within 24 hours) will be evaluated.
Furthermore, data of the balloon catheter PLEON EXPLORER will be collected to demonstrate
its effectiveness and safety.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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