The (PIVOTAL) Study
- Conditions
- ABDOMINAL AORTIC ANEURYSMS
- Interventions
- Device: AneuRx AAA stent graft / Talent AAA stent graft
- Registration Number
- NCT00444821
- Lead Sponsor
- Medtronic Cardiovascular
- Brief Summary
The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 728
- 40 to 90 years of age
- 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
- Meet any of the Contraindications stated in the Medtronic Vascular AAA Endograft instructions for Use
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early Endovascular Repair AneuRx AAA stent graft / Talent AAA stent graft -
- Primary Outcome Measures
Name Time Method Number of Subjects That Experienced Rupture or Aneurysm Related Death 3 years
- Secondary Outcome Measures
Name Time Method Aneurysm Growth >0.5 cm 1 year After repair, AAA enlargement by \>0.5cm
Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up study termination secondary interventions in those that had successful delivery and deployment by treatment group randomized to.
Trial Locations
- Locations (63)
University of Southern California
🇺🇸Los Angeles, California, United States
Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
University of Chicago
🇺🇸Chicago, Illinois, 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
Stanford University Medical Center
🇺🇸Stanford, California, United States
Leesburg Regional Medical Center
🇺🇸Leesburg, Florida, United States
St. Joseph's Research Institute
🇺🇸Atlanta, Georgia, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
Wellstar Clinical Trials
🇺🇸Marietta, Georgia, United States
Adventist Midwest Health
🇺🇸Hinsdale, 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
🇺🇸Bel Air, Maryland, United States
Michigan Vascular Center
🇺🇸Flint, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, 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
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
East Carolina University
🇺🇸Greenville, North Carolina, 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
UPMC Vascular Surgery
🇺🇸Pittsburgh, Pennsylvania, United States
North Central Heart Institute
🇺🇸Sioux Falls, South Dakota, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
University Surgical Associates
🇺🇸Chattanooga, Tennessee, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Sentara Heart Hospital
🇺🇸Norfolk, Virginia, United States
Wisconsin Heart / Meriter Hospital
🇺🇸Madison, Wisconsin, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
St. Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Texas
🇺🇸Temple, Texas, United States
The Lindner Clinical Trials Center
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Oregon
🇺🇸Medford, Oregon, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Stanford University VA
🇺🇸Palo Alto, California, United States
Southern Illinois University
🇺🇸Springfield, Illinois, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States