Medtronic’s Endurant II/IIs EVAR Device to Be Evaluated in the Global ADVANCE Postmarket Randomized Trial

January 11, 2023—Medtronic announced the commencement of the ADVANCE trial, a global postmarket study of the company’s Endurant II/IIs bifurcated stent graft system, which is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms. The prospective, interventional, multicenter, randomized controlled trial will enroll a minimum of 550 patients at up to 50 centers globally.

The first patient in the ADVANCE trial was enrolled by a team led by Ray Workman, MD, at Novant Health Forsyth Medical Center in Winston-Salem, North Carolina.

According to Medtronic, patients in the head-to-head randomized controlled trial will receive endovascular aneurysm repair (EVAR) to treat abdominal aortic aneurysms (AAAs) with either the Endurant II/IIs stent graft system family or the Excluder AAA family of grafts (Gore & Associates) and will be followed at 1 month, 1 year, and annually through 5 years.

The company stated that the ADVANCE trial aims to further the understanding of sac regression by robust evaluation of CT imaging utilizing an independent core lab through 5 years.

The trial will provide a comparison of aneurysm sac regression outcomes between the Endurant II/IIs and Excluder device families with additional evidence to analyze risk factors related to aneurysms that fail to regress. The trial will also compare other key clinical outcomes between the two stent grafts, including endoleaks, migration, secondary interventions, mortality, and renal complications.

Professor Hence Verhagen, MD, and Marc Schermerhorn, MD, are Coprincipal Investigators of the ADVANCE trial. Prof. Verhagen is Professor of Vascular Surgery, head of Vascular Surgery at Erasmus MC in Rotterdam, the Netherlands. Dr. Schermerhorn is Chief of Vascular and Endovascular Surgery at Beth Israel Deaconess Medical Center in Boston, Massachusetts.

“Through the ADVANCE trial, we are working to deepen our evidence of sac regression as a key indicator of long-term EVAR patient outcomes,” commented Prof. Verhagen in Medtronic’s press release. “Our hope is that the findings will allow physicians to make evidence-based clinical decisions to improve long-term patient outcomes.”

Dr. Schermerhorn added, “We are pleased to announce the first patient enrolled in the ADVANCE trial. This milestone underscores the commitment to rigorous study of the long-term data around the durability of the Endurant system for patients in need of EVAR. The results of the trial aim to demonstrate contemporary outcomes and our overarching goal to deliver superior aortic patient care through robust and rigorous clinical data.”

Medtronic advised that the ADVANCE trial draws on clinical data showing that 1-year sac regression is an early indicator of improved long-term survival (O’Donnell, et al; Journal of Vascular Surgery; 2019;69:414-422). Those outcomes were consistent with the 8-year results from the company’s ENGAGE OUS Registry demonstrating the long-term clinical safety and effectiveness of the Endurant stent graft system, the abstract of which was published online in January 2022 (Teikjink, et al; EJVES Vascular Forum). The ENGAGE OUS Registry followed patients through 10 years, noted the company.