IHI ABSORB-10-392 ABBOTT-A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions
ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 3000 subjects from approximately 140 sites in the United States and outside the United States. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.
The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System (once commercially available), as compared to the commercially approved, control stent XIENCE.
Heart and Vascular,
James T. Maddux, M.D.
- Montana Research
- Providence St. Patrick Hospital