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

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Eligible age

20+ yrs

Accepts

All genders

Locations

21 states

Healthy volunteers

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About this study

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.

Sponsor: Medtronic Cardiovascular

You may qualify if…

✓ Subject and the treating physician agree that the subject will return for all required follow up visits
✓ Subject or legal representative or consultee, as applicable, has consented for trial participation and signed the Informed Consent approved by the sponsor and by the Ethics Committee/Institutional Review Board
✓ Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man) or as stated otherwise in regional addenda.
✓ Subject's AAA anatomy is appropriate for both Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis as per assessment of both treating physician and Core Lab in accordance with the overlapping commercially available IFUs per applicable region.

You may not qualify if…

✕ Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial
✕ Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator
✕ Subject has an aneurysm that is:
✕ 1. Suprarenal/pararenal/juxtarenal
✕ 2. Isolated ilio-femoral
✕ 3. Mycotic
✕ 4. Inflammatory
✕ 5. Pseudoaneurysm