Phase II results from the safety and feasibility trial of the Relay (Bolton Medical) thoracic stent-graft indicate comparable mortality and fewer endoleaks than in phase I, according to data presented by Dr Mark A Farber, University of North Carolina, USA. The phase I enrolled 30 patients through August 2006, with an average follow-up of 20.5 months. Phase II plans to enroll patients with thoracic aortic pathologies at 26 sites to receive either the Relay (Bolton Medical) device (n=120) or open surgery (n=60). As of August 2008, 52 patients have been enrolled in the endovascular arm. The main safety endpoint is cumulative 1-year major adverse events.
Phase II results, currently available for 51 patients, indicate that successful deployment of the stent-graft was achieved in 48 (94.1%) patients, and the procedure was free of complications in 41 (82%). Endoleaks occurred in two (3.9%) patients, but there were no conversions to open repair. There were no treated aneurysm ruptures, no lesion size increases, and no surgical conversions, migration, or lumen occlusion in either trial. In light of the data, phase II is expected to be completed, but Farber said, “You can tell it is going to take some time in the United States for that to happen because of stringent regulations.”
