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

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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.

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.

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
1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Albany, New York 12208
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509 Biltmore Ave
Asheville, North Carolina 28801
(828) 213-1111
Mission Hospitals Mission Hospital, the flagship hospital of Mission Health, has been committed to improving...
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Asheville, NC
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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Birmingham, Alabama 35294
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Buffalo, New York 14214
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Charlotte, North Carolina 28204
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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Cincinnati, Ohio 45219
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Cincinnati, OH
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Downers Grove, Illinois 60515
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Marietta, Georgia 30106
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Memphis, Tennessee 38120
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New York, New York 10016
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New York, New York 10029
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85006
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Powell, Tennessee 37849
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1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Sioux Falls, South Dakota 65104
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St. Louis, Missouri 63141
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Temple, TX
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Toledo, Ohio 43606
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