Emory Healthcare has completed the first patient case in the ARISE III clinical trial to treat a life-threatening heart condition, called acute type A aortic dissection, using an investigational ascending stent graft. The minimally invasive procedure is considered more suitable for higher risk populations versus an open-heart surgery to repair the dissection or tear.

“This type of trial will ‘move the needle’ in the treatment of acute type A aortic dissection and truly is a game changer, particularly for elderly patients with multiple comorbidities,” explains Brad Leshnower, MD, director of thoracic aortic surgery at Emory Healthcare and professor of surgery at Emory University School of Medicine.

Leshnower performed the first surgical case using the investigational device developed by the medical company Gore, along with two additional Emory cardiovascular surgeons Yazan Duwayri, MD, and Jonathan Zurcher, MD.

The ARISE III trial is a prospective, multicenter, non-randomized pivotal study approved by the U.S. Food and Drug Administration (FDA) to assess the safety and effectiveness of the investigational Gore Ascending Stent Graft in patients with acute Type A aortic dissections who are considered high risk for conventional surgery. The study will enroll up to 112 patients at multiple centers across the United States. Each enrolled patient will be closely monitored throughout the study, with follow-up assessments conducted for up to five years to evaluate safety and effectiveness outcomes over the long term.

Open heart surgery has been the standard treatment for acute type A aortic dissection, a rare condition that occurs when a tear forms in the inner layer of the aorta where it leaves the heart. Symptoms may include severe chest, upper back or stomach pain that feels like something is tearing or ripping. Early diagnosis and quick medical management and treatment of the condition greatly improve the chance of survival.

“We hope this new device and procedure will provide an alternative option to open heart surgery for patients to reduce morbidity, mortality and give patients a better quality of life,” says Leshnower.

To learn more about the ARISE III trial on Gore’s website.