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Keep this study
Lead
Medtronic Cardiovascular
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System
