Update on the ARISE Trial: TEVAR for Type A Dissection With the Gore Ascending Aortic Stent Graft (ASG)

Hollywood, FL (January 24, 2020) – The Gore Ascending Aortic Stent Graft (ASG) is being tested in an early feasibility trial, offering new hope for using thoracic endovascular aortic repair (TEVAR) to treat Type A aortic dissections.

Joseph Bavaria, MD, Director of the Thoracic Aortic Surgery Program at the University of Pennsylvania, presented an update on the trial during an early morning session at the International Symposium on Endovascular Therapy (ISET).

Dr. Bavaria could have likely started and ended his presentation with a show-stopping slide relating results from a recent Japanese study. The study found that fully 8.07% of out-of-hospital arrests were seen on post-mortem computed tomography angiography (CTA) to be due to acute aortic Type A dissection, “not from [myocardial infarctions] or the other issues that we always thought,” said Bavaria.

Indeed, he called Type A dissection the “Holy Grail” in the TEVAR universe. “Really this is about whether type A dissection can be initially repaired with TEVAR,” said Dr. Bavaria, and “well, we’re not 100% sure [it can] but we’re going down this road.”

ARISE is a multicenter, early feasibility study evaluating the endovascular ASG, a purpose-built investigational device specifically designed to treat type A dissections of the ascending aorta.

Currently, the trial has enrolled 31 “highly selected” ASG cases, 11 in the acute type A arm (feasibility) and 18 emergent/compassionate use cases, which includes both type As and other ascending pathologies, reported Bavaria. The study is being conducted at 8 U.S. sites.

While a proper assessment of the new graft will have to await final results, Dr. Bavaria reported that, “we've been very, very pleased with the ability, just like in TAVI, to get very close to the valve without getting into the valve.” He added that the technical characteristics of the ASG graft “are pretty reasonable”.