Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System
NCT ID: NCT00705718
Last Updated: 2021-11-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
194 participants
INTERVENTIONAL
2008-06-30
2016-09-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endurant Bifurcated arm
The Bifurcated arm includes subjects who have received a bifurcated device. The Endurant Stent Graft System Bifurcated device is administered to treat patients with an Abdominal Aortic Aneurysm.
Endurant Stent Graft System
Abdominal Aortic Aneurysm Repair
Endurant AUI arm
The AUI arm includes subjects who have received an AUI device. The Endurant Stent Graft System AUI device is administered to treat patients with an Abdominal Aortic Aneurysm.
Endurant Stent Graft System
Abdominal Aortic Aneurysm Repair
Interventions
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Endurant Stent Graft System
Abdominal Aortic Aneurysm Repair
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Michel S Makaroun, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Vascular Surgery University of Pittsburgh Medical Center
Locations
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University of Alabama Hospitals
Birmingham, Alabama, United States
Arizona Heart Institute
Phoenix, Arizona, United States
Stanford University Medical Center
Stanford, California, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Good Samaritan Hospital
Downers Grove, Illinois, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Albany Medical Center
Albany, New York, United States
Sisters of Charity Hospital
Buffalo, New York, United States
NYU Hospitals Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Mission Hospitals
Asheville, North Carolina, United States
Mid Carolina Presbyterian Hospital
Charlotte, North Carolina, United States
Lindner Clinical Trial Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Jobst Vascular Center
Toledo, Ohio, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Sanford Research
Sioux Falls, South Dakota, United States
Baptist Memorial Hospital Memphis
Memphis, Tennessee, United States
Premier Surgical Associates
Powell, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Scott & White Memorial Medical Center
Temple, Texas, United States
Harborview Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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Medtronic - 089
Identifier Type: -
Identifier Source: org_study_id