A Clinical Evaluation of Absorb BVS the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions
Brief Description Of Study
The ABSORB III Randomized Controlled Trial (RCT), evaluates the safety and effectiveness of the Absorb Bioresorbable Vascular Scaffold (BVS) System compared to the XIENCE. The ABSORB III RCT includes a Lead-In phase and an Imaging Cohort and inclused a maximum of 220 sites in the United States and outside the United States. The ABSORB III primary endpoint is target lesion failure (TLF is caridac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization) at 1 year. ABSORB III is a prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center trial, registering about 2250 subjects. This is the pivotal trial to support the US PMA approval of Absorb BVS. The primary objective of ABSORB III is to evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels. The primary endpoint data from this trial will be based on approximately 2000 subjects and will support label claims of non-inferiority of Absorb BVS as compared to XIENCE in 1-year TLF. The ABSORB III will also include a Lead-In Phase and an Imaging Cohort. The ABSORB III will also support a diabetes indication for Absorb BVS. The Lead-In Phase is closed to enrollment ABSORB Imaging Cohort A prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center cohort, registering about 200 subjects. The primary objective of the ABSORB Imaging Cohort is to evaluate long-term vascular function and patency of the Absorb BVS treated segments compared to XIENCE treated segments. Data from two major secondary endpoints from this cohort will support label claims of superiority of Absorb BVS to XIENCE specific to vasomotion and late lumen enlargement. Our site is not participating in the Imaging Cohort. ABSORB IV is a prospective, randomized (1:1 Absorb BVS to XIENCE), single-blind, multicenter study, registering approximately 3000 subjects at about 140 sites. The primary objective is evaluating angina within 1 year and target lesion failure between 1 and 5 years. Patient reported outcomes will assess health related quality of life.