Gore Ascending Stent Graft’s ARISE II Pivotal Study Enrolls First Patient

December 20, 2023—Gore & Associates announced the commencement of the ARISE II pivotal trial. The study is investigating treatments for pathologies involving the ascending aorta using endovascular repair with the Gore Ascending Stent Graft rather than traditional open surgery.

According to Gore, the FDA-approved ARISE II study is investigating the endovascular treatment of isolated lesions as well as chronic and residual Type A dissections involving the ascending aorta. The company’s Ascending Stent Graft is designed for investigational use in combination with the Gore TAG thoracic branch endoprosthesis.

ARISE II will evaluate how the transcatheter endovascular stent graft may be used to line the diseased portion of the ascending aorta as a potential alternative to open surgical repair. Although endovascular technologies have been applied to other regions of the aorta to reduce the risk of complications and recovery times, no endovascular device is currently approved for the ascending aorta, noted the company.

Eric Roselli, MD, who is Chief of Adult Cardiac Surgery at Cleveland Clinic in Cleveland, Ohio, serves as National Principal Investigator of the ARISE II trial.

Dr. Roselli performed the initial implantation with study investigators Patrick Vargo, MD, and Frank Caputo, MD, on December 1. The patient was identified as a candidate for the study after presenting with a fusiform aneurysm of the ascending aorta and aortic arch.

“The treatment of the ascending aorta has long been a ‘final frontier’ in endovascular surgery. ARISE II is a significant step forward as we search for minimally invasive options that can be offered to higher risk patients,” commented Dr. Roselli in Gore’s press release.

Dr. Caputo, who is Vascular Surgery Director of the Aorta Center at Cleveland Clinic, added, “Our patient is recovering well. Having a minimally invasive alternative would be a significant advancement for patients not suitable for open surgery.”

Gore’s Ascending Stent Graft is an investigational device limited by United States law to investigational use, advised the company.

In August 2018, the company announced initiation of the multicenter ARISE early feasibility study evaluating the Gore Ascending Stent Graft.