A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular
Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions
This is a prospective, randomized, single-blind, multi-center trial, conducted in three cohorts.
ABSORB III Primary Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. The ABSORB III Cohort will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.