Study Results
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View full resultsBasic Information
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TERMINATED
NA
728 participants
INTERVENTIONAL
2005-03-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surveillance
No interventions assigned to this group
Early Endovascular Repair
AneuRx AAA stent graft / Talent AAA stent graft
Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Interventions
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AneuRx AAA stent graft / Talent AAA stent graft
Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Eligibility Criteria
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Inclusion Criteria
* Meet all indications for use as stated in the Medtronic Vascular AAA Endograft Instructions for Use
* Maximum aneurysm diameter of 4-5cm
* If female patient with child bearing potential, must have a documented negative pregnancy test within seven(7)days prior to inclusion
* Patient is willing and able to comply with the specified follow-up evaluation
* Life expectancy at least 3 years
Exclusion Criteria
* Known co-existing condition with a life expectancy of less than 3 years
* Major surgical or interventional procedure (vascular and/or non-vascular)within 30 days prior to study enrollment
* Subjects enrolled in another clinical trial or anticipated to be included into a trial, which may interfere with this study, or subjects already enrolled in this trial before.
* Planned conduit procedure for introduction of endograft
40 Years
90 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Ouriel, MD
Role: PRINCIPAL_INVESTIGATOR
New York Presbyterian Hospital
Locations
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University of Alabama
Birmingham, Alabama, United States
Tucson Vascular Surgery
Tucson, Arizona, United States
University of Arizona - UMC
Tucson, Arizona, United States
VA Hospital
Little Rock, Arkansas, United States
Palomar Hospital
Escondido, California, United States
Long Beach VA Healthcare System
Long Beach, California, United States
UCLA Medical Center
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
Stanford University VA
Palo Alto, California, United States
UC Davis Medical Center
Sacramento, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Leesburg Regional Medical Center
Leesburg, Florida, United States
University of South Florida
Tampa, Florida, United States
St. Joseph's Research Institute
Atlanta, Georgia, United States
Wellstar Clinical Trials
Marietta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Adventist Midwest Health
Hinsdale, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
Cardiac Surgery Associates
Munster, Indiana, United States
Iowa Heart Center
Des Moines, Iowa, United States
Tri-State Vascular Group
Ashland, Kentucky, United States
Vascular Surgery Associates
Baton Rouge, Louisiana, United States
Vascular Surgery Associates
Bel Air, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Michigan Vascular Center
Flint, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
South Central Regional Medical Center
Laurel, Mississippi, United States
St. John's Regional Medical Center
Joplin, Missouri, United States
Albany Medical Center
Albany, New York, United States
Westchester Medical Center
Hawthorne, New York, United States
Columbia University Medical Center
New York, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Mission / St. Joseph Hospital
Asheville, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
The Lindner Clinical Trials Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
The Dayton Heart Center
Dayton, Ohio, United States
Jobst Vascular Center
Toledo, Ohio, United States
Oregon
Medford, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
UPMC Vascular Surgery
Pittsburgh, Pennsylvania, United States
North Central Heart Institute
Sioux Falls, South Dakota, United States
University Surgical Associates
Chattanooga, Tennessee, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
St. Thomas Hospital
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Methodist Dallas Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
Texas
Temple, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Sentara Heart Hospital
Norfolk, Virginia, United States
Sacred Heart Medical Center
Spokane, Washington, United States
Wisconsin Heart / Meriter Hospital
Madison, Wisconsin, United States
Countries
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References
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Eisenstein EL, Davidson-Ray L, Edwards R, Anstrom KJ, Ouriel K. Economic analysis of endovascular repair versus surveillance for patients with small abdominal aortic aneurysms. J Vasc Surg. 2013 Aug;58(2):302-10. doi: 10.1016/j.jvs.2013.01.038. Epub 2013 Apr 4.
Other Identifiers
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VS-2005-01
Identifier Type: -
Identifier Source: org_study_id
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