Abbott has started the ABSORB II clinical trial of its Absorb bioresorbable vascular scaffold (BVS) system.
The controlled, multi-center, randomized trial, enrolling 500 patients with coronary artery disease, is designed to assess the safety, efficacy and performance of the Absorb BVS compared to the company’s Xience Prime Everolimus Eluting Coronary Stent System.
The primary endpoints of the trial are change in dimension of the lumen over time and vasomotion at the treated vessel segment, which will be evaluated based on changes in the vessel diameter in response to a stimulus.
Abbott Vascular Medical Affairs divisional vice president and CMO Charles Simonton said this is the first trial to assess clinical endpoints that may be unique to a bioresorbable device, such as measuring the ability of the vessel to respond to normal blood pressure changes.
"The potential to restore a treated vessel back to a more natural state will also be assessed in this trial," Simonton said.