Endurant Stent Graft System US Clinical Study
To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- device : Endurant Stent Graft System
Phase: Phase 3
Ages Eligible For Study:
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.