Stanford Completes First Investigational Endovascular Ascending Aorta Stent Graft in the Western U.S. as Part of ARISE II National Clinical Trial

by CT Surgery Marketing Team
February 1, 2025

The Stanford Department of Cardiothoracic Surgery recently became the first trial site in California to implant a novel ascending stent graft device in a patient, marking a step toward advancing new frontiers in endovascular surgery.

While endovascular stent grafts are available for repairing aneurysms or dissections in the descending aorta, there are no approved devices for the ascending aorta. As part of a five-year National Institutes of Health clinical trial, Stanford surgeons are testing an ascending aorta stent graft as a minimally invasive alternative to open surgery.

Surgeons from the Stanford Department of Cardiothoracic Surgery and Stanford’s Division of Vascular & Endovascular Surgery are collaborating to evaluate the new ascending stent graft as part of a multicenter clinical trial. The principal investigator, A. Claire Watkins, MD, Clinical Assistant Professor of Cardiothoracic Surgery, is working in close partnership with Jason T. Lee, MD, Chief of the Division of Vascular Surgery in the Department of Surgery at Stanford Medicine, to carry out the trial.

“The ARISE II study is the next frontier in endovascular management of aortic aneurysm and dissection,” says Dr. Watkins, who specializes in endovascular and transcatheter cardiac surgery. "Stanford has a long history of innovation in this field, including the development of the first aortic stent grafts for the descending aorta by Interventional Radiologist and Professor Emeritus of Cardiothoracic Surgery, Michael D. Dake, MD, in 1994. Our expertise in managing complex aneurysms and dissections makes us well-suited to participate in this trial."

The 61-year-old patient, who met the strict criteria for the trial, had a history of chronic type B aortic dissection with aneurysmal degeneration. Aneurysms are risky due to their potential to rupture. The patient was offered an endovascular stent graft through the trial and accepted. The only way to receive the investigational device is to be evaluated by a participating center and to qualify for the criteria of the clinical trial.

“The patient did well and was discharged home three days after stent placement without complications,” Dr. Watkins says.

Had the patient received open-heart surgery, doctors suspect that the hospital stay would likely have been a week, followed by four to six weeks of recovery at home.

“I often tell my patients that putting in the stent is the easy part. The real benefit of Stanford for them is having access to multidisciplinary input and the very latest technology,” Dr. Watkins says.

Stanford is nationally and internationally recognized as a top-tier center for clinical trials of aortic stent grafts and devices. If the clinical trial proves successful, patients will have a minimally invasive option for ascending aorta disease.

“We are fortunate to be part of the ARISE II national clinical trial, testing the newest technology to provide an endovascular solution to the ascending aorta,” says Dr. Lee. “The challenges of that portion of the aorta are unique for minimally invasive options, and with Dr. Watkins' leadership, we treated the first patient on the West Coast under this national clinical trial.”

Stanford is one of five sites in California participating in the ARISE II national clinical trial, along with several sites across the nation. This multicenter trial began in November 2023 and will run through October 2029.