Comparison of Medtronic Endurant IIIIs and Gore Excluder Devices for Treating Abdominal Aortic Aneurysms in a Global Randomized Study

What this Trial Is About

Researchers are conducting a global, multi-center clinical trial to compare the performance of two devices used to treat Abdominal Aortic Aneurysms AAA the Medtronic Endurant IIIIs Stent Graft System and the Gore ExcluderExcluder Conformable AAA Endoprosthesis. The study aims to generate clinical evidence on key outcomes such as sac regression in patients who undergo endovascular aneurysm repair EVAR. Approximately 600 subjects will be enrolled and followed for up to five years. Participants are randomly assigned to receive EVAR treatment with either the Medtronic Endurant IIIIs device or the Gore Excluder device. Imaging and data collection happen before and after the procedure, at discharge, 30 days post-procedure, and annually up to five years. Imaging is reviewed by a central core laboratory to assess primary and secondary outcomes. During the trial, participants will undergo regular imaging and clinical assessments to monitor aneurysm sac changes, endoleaks, secondary interventions, and overall survival rates. Researchers will evaluate sac regression at 12 months as the primary outcome and continue annual follow-ups up to five years to observe longer-term effects. Participants will have scheduled visits at defined intervals to support these assessments and ensure ongoing safety monitoring.

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial