ARISE III Trial of Gore Ascending Stent Graft Begins Enrollment

December 15, 2025—Gore & Associates announced the first implantation of its investigational Gore Ascending Stent Graft in the ARISE III trial for the treatment of an acute type A dissection.

The FDA-approved ARISE III trial is a prospective, multicenter, nonrandomized pivotal study assessing the safety and effectiveness of the Gore Ascending Stent Graft in patients with acute type A aortic dissections who are considered high risk for surgery.

According to the company, the study will enroll up to 112 patients at multiple centers across the United States. Each patient will be closely monitored throughout the study, with follow-up assessments conducted for up to 5 years to evaluate safety and effectiveness outcomes over the long term.

The company reported that the initial implantation was performed at Emory University in Atlanta, Georgia, by Brad Leshnower, MD, Site Principal Investigator and Director of Thoracic Aortic Surgery, and Yazan Duwayri, MD, Study Investigator and Chief of Vascular Surgery and Endovascular Therapy.

“The ascending aorta presents a challenging environment for the use of endovascular devices due to the high blood flow rates and significant motion and angulation,” commented Dr. Leshnower in the company’s press release. “The procedure went well, and the patient is recovering. Having a catheter-based solution where the patient does not have to be placed on cardiopulmonary bypass or circulatory arrest could change how we think about treating patients—and ultimately broaden treatment options for complex cases.”

The ARISE III National Principal Investigator is Eric Roselli, MD, Chief of Adult Cardiac Surgery at the Cleveland Clinic in Cleveland, Ohio.

“Ascending aortic dissection is a surgical emergency that presents serious risk to a complex group of patients and can be challenging to treat,” commented Dr. Roselli in Gore’s press release. “The ARISE III study is designed to evaluate an endovascular option as a potential solution for high-risk patients with acute type A dissection. This first implant in the pivotal trial is a vital step on the path toward expanding options for more patients.”