Peripheral Arterial Disease Clinical Trial
Official title:
Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
This is a prospective, single-center, non-randomized phase 2, first-in-iliac artery study, to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of peripheral arterial occlusive disease in symptomatic subjects with de novo or restenotic lesions in the common iliac artery (CIA) and/or external iliac artery (EIA), including lesions at the aortic bifurcation.
Approximately 30 subjects will be enrolled. Post study procedure subjects will have planned
follow-up visits at 4 weeks, 24, 36 and 52 weeks, and unscheduled visits as medically
necessary,
The primary study safety endpoint is the proportion of subjects free from a composite of
device- or procedure-related death, myocardial infarction, or amputation above the
metatarsals in the treated leg resulting from a vascular event, or device- or
procedure-related serious adverse events within 4 weeks of the index procedure. The primary
clinical effectiveness endpoint is the proportion of subjects with a composite improvement of
at least 1 Rutherford category and patency as evaluated by duplex ultrasound at 4 weeks after
index procedure.
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