Trial Search Results
Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System
To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.
Stanford is currently not accepting patients for this trial.
- Device: Endurant Stent Graft System
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
3. Subject is able and willing to comply with the protocol and undergo follow-up
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
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
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.
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study