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Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial — ADVANCE  

Abdominal Aortic Aneurysm Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. An estimate of 550 subjects (minimum 500) are enrolled at up to 100 sites globally, with the potential to extend enrollment up to 900 subjects based on predictive probability analysis to adequately achieve either non-inferiority or superiority for the primary endpoint. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05378347
Study type Interventional
Source Medtronic Cardiovascular
Contact ADVANCE Trial Clinical Study Team
Phone 763-514-4000
Email rs.advancestudy@medtronic.com
Status Recruiting
Phase N/A
Start date January 5, 2023
Completion date May 2029
View Details
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