Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

Launched by MEDTRONIC CARDIOVASCULAR · Jun 25, 2008

Keywords

ClinConnect Summary

Prospective, two-arm, non-randomized, multicenter clinical study enrolling subjects treated with the bifurcated stent graft in one arm and subjects treated with the AUI in a second arm.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is ≥ 18 years old.
• • 2. Subject (or Subject's legal representative) understands and voluntarily has signed and dated an Informed Consent document approved by the Sponsor and by the Institutional Review Board.
• • 3. Subject is able and willing to comply with the protocol and undergo follow-up requirements.
• • 4. Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, III, or IV
• • 5. Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter
• • 6. Subject meets all the protocol anatomical criteria\* as demonstrated on contrast-enhanced CT or MRA
• • 7. Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft
• • 8. Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral artery, or can tolerate a vascular conduit that allows introduction of the device.
• • 9. Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System.
• Exclusion Criteria:
• • 1. Subject has a life expectancy \< 1 year
• • 2. Subject is participating in another investigational drug or device study
• • 3. Subject requires emergent aneurysm treatment
• • 4. Subject is a female of childbearing potential in whom pregnancy cannot be excluded.
• • 5. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
• • 6. Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.