Feasibility Study Begins for the Gore Ascending Stent Graft to Treat Type A Dissection
August 27, 2018—Gore & Associates, Inc. announced the initiation of the FDA-approved Gore ARISE study, a multicenter, early feasibility study evaluating the endovascular Gore Ascending Stent Graft. The investigational device is specifically designed to treat type A dissections of the ascending aorta. The study will investigate how this endovascular stent graft may be used to line the dissected portion of the ascending aorta as a less-invasive alternative to open surgical repair.
The first implantation of the device in the study was performed by Anthony Estrera, MD, and Bruce Tjaden, MD, at Memorial Hermann Medical Center in Houston, Texas. The ARISE study’s national principal investigator is Michael Reardon, MD, from Houston Methodist Hospital in Houston, Texas.
According to the company, the ARISE study initially investigated the use of the Gore TAG thoracic branch endoprosthesis (aortic extender) in type A dissection. The Gore TAG is also being evaluated in a pivotal study to assess the safety and effectiveness in treating lesions of the aortic arch and descending thoracic aorta.
The new purpose-built Gore ascending stent graft will be used for the remainder of the study to allow investigators to gain a better understanding of how new technology can advance treatment options for this condition. The device's delivery system features angulation control that gives physicians the option to angulate the device to achieve orthogonal placement to the ascending aorta, noted the company.
In the company's announcement, Dr. Estrera commented, “There is a great need for a less-invasive treatment option for type A dissections, which are fatal for nearly half of all sufferers within 48 hours of onset. I’m excited that Gore is breaking ground in this area with the development of the first endovascular device specifically designed to meet the anatomical, curvature, and deployment precision requirements unique to the ascending aorta. This device, upon approval, could provide a treatment option for type A dissection patients who aren’t suitable for open surgery and a less-invasive treatment for all patients with this condition.”