NCT05378347

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.

Detailed description

This is a post-market, prospective, interventional, global, multi-center, randomized, dual-arm clinical trial. The primary objective of this trial is to evaluate sac regression outcomes of the Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis in standard EVAR subjects. Subjects are randomized on a 1:1 basis to receive EVAR with either a Medtronic Endurant II/IIs Stent Graft Systems or Gore Excluder / Excluder Conformable AAA Endoprosthesis. Data is collected pre- and post-procedure at discharge, at 30 days, and once a year until the 5-year follow-up is completed. Approximately 600 subjects are planned to be enrolled at up to 100 sites globally. Product Names: * Medtronic Endurant II/IIs Stent Graft System * Gore Excluder and/or Gore Excluder Conformable AAA Endoprosthesis Imaging is collected for all follow-up time points and are evaluated by a core lab for the key primary and secondary objectives.

Conditions

• Abdominal Aortic Aneurysm
• Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)
• Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)

Interventions

Type	Name	Description
DEVICE	Medtronic Endurant II or Endurant IIs Stent Graft System	EVAR treatment with Medtronic Endurant II/IIs Stent Graft System
DEVICE	Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis	EVAR treatment with Excluder / Excluder Conformable Stent Graft System

Timeline

• Start date: 2023-01-05
• Primary completion: 2027-05-01
• Completion: 2031-05-01
• First posted: 2022-05-18
• Last updated: 2026-04-08

Locations

68 sites across 12 countries: United States, Finland, France, Germany, Greece, Italy, Japan, Netherlands, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated device study