Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System
Status: | Active, not recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | June 2008 |
End Date: | November 2016 |
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.
Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.
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.
with the bifurcated stent graft in one arm and subjects treated with the AUI in a second
arm.
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.
We found this trial at
30
sites
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Mission Hospitals Mission Hospital, the flagship hospital of Mission Health, has been committed to improving...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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