Gore recently announced the first implantation of the investigational Gore ascending stent graft in the ARISE III trial for the treatment of an acute type A dissection.
The implant was performed at Emory University (Atlanta, USA) by Brad Leshnower, site principal investigator, and Yazan Duwayri, study investigator.
Eric Roselli (Cleveland Clinic, Cleveland, USA), national principal investigator, stated: “Ascending aortic dissection is a surgical emergency that presents serious risk to a complex group of patients and can be challenging to treat.”
While open repair is the current standard, there are many patients who are not candidates for open surgery or are at high risk for surgery. Gore details that medical management of type A dissections carries a rapidly escalating risk, with mortality increasing 0.5–1 per cent per hour for the first two days, reaching 60 per cent in-hospital mortality.
“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,” Roselli added.
Leshnower remarked that 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”.
“The procedure went well, and the patient is recovering,” he reported. “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 trial is a prospective, multicentre, non-randomised pivotal study approved by the US Food and Drug Administration (FDA) to assess the safety and effectiveness of the Gore ascending stent graft in patients with acute type A aortic dissections who are considered high risk for conventional surgery.
The study will enrol up to 112 patients at multiple centres across the USA. 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.
Gore notes that ARISE III builds on the company’s ARISE early feasibility study and ARISE II pivotal trial, which is currently enrolling at hospitals across the USA. Together, these trials aim to develop an endovascular treatment option for various ascending aorta pathologies as an alternative to open surgery or medical management.
