Status:
COMPLETED
Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Abdominal Aortic Aneurysms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.
Detailed Description
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.
Eligibility Criteria
Inclusion
- Subject is ≥ 18 years old.
- 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.
- Subject is able and willing to comply with the protocol and undergo follow-up requirements.
- 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
- Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter
- Subject meets all the protocol anatomical criteria\* as demonstrated on contrast-enhanced CT or MRA
- Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft
- 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.
- Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System.
Exclusion
- Subject has a life expectancy \< 1 year
- Subject is participating in another investigational drug or device study
- Subject requires emergent aneurysm treatment
- Subject is a female of childbearing potential in whom pregnancy cannot be excluded.
- Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
- Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2016
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00705718
Start Date
June 1 2008
End Date
September 26 2016
Last Update
November 3 2021
Active Locations (30)
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1
University of Alabama Hospitals
Birmingham, Alabama, United States, 35294
2
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
3
Stanford University Medical Center
Stanford, California, United States, 94305
4
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239