Safety and Efficacy Study of the Amaranth Medical MAGNITUDE Bioresorbable Drug-Eluting Coronary Stent (RENASCENT III)

Summary

Participation Requirements

Description

The objective of this study is to evaluate the safety and performance of the AmM MAGNITUDE Bioresorbable Drug-Eluting Coronary Scaffold for use in the treatment of up to two different de novo native coronary artery lesions in patients undergoing elective percutaneous coronary intervention. The scaff...

The objective of this study is to evaluate the safety and performance of the AmM MAGNITUDE Bioresorbable Drug-Eluting Coronary Scaffold for use in the treatment of up to two different de novo native coronary artery lesions in patients undergoing elective percutaneous coronary intervention. The scaffold is a single-use device comprised of a balloon-expandable, intracoronary drug coated scaffold pre-mounted on a rapid-exchange delivery catheter. The scaffold is made of Poly-L-Lactide (PLLA) and is coated with a polymer-antiproliferative drug (sirolimus) matrix. The scaffold provides mechanical support similar to a metallic stent to the vessel while it is healing, and then gradually breaks down over time leaving no permanent implant in the treated vessel. Compared to prior versions of the scaffold, the new device has a thinner strut design (a wall thickness of 100 µm rather than 120 µm or 150 µm), but is otherwise identical. The study design is a prospective, non-randomized, multi-center, non-inferiority trial. It will enroll a maximum of 70 patients from up to 20 investigational centers in Colombia and the European Union. Eligible patients who are at least 18 years of age diagnosed with symptomatic ischemic disease due to up to two different, de novo, stenotic lesions in native coronary arteries will be asked to participate in this study. After treatment with the investigational device, subjects will be followed for five years. Safety of the device will be evaluated using the incidence of target vessel failure during the follow-up period. Performance (efficacy) will be assessed using the in-scaffold late lumen loss measured by quantitative coronary angiography at nine months.

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