ABDOMINAL AORTIC ANEURYSMS Clinical Trial
Official title:
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
| NCT number | NCT00444821 |
| Other study ID # | VS-2005-01 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2005 |
| Est. completion date | January 2010 |
| Verified date | October 2021 |
| Source | Medtronic Cardiovascular |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 728 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 90 Years |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Albany Medical Center | Albany | New York |
| United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Mission / St. Joseph Hospital | Asheville | North Carolina |
| United States | Tri-State Vascular Group | Ashland | Kentucky |
| United States | St. Joseph's Research Institute | Atlanta | Georgia |
| United States | Vascular Surgery Associates | Baton Rouge | Louisiana |
| United States | Vascular Surgery Associates | Bel Air | Maryland |
| United States | University of Alabama | Birmingham | Alabama |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | University of North Carolina | Chapel Hill | North Carolina |
| United States | Presbyterian Hospital | Charlotte | North Carolina |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | University Surgical Associates | Chattanooga | Tennessee |
| United States | University of Chicago | Chicago | Illinois |
| 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 | Methodist Dallas Medical Center | Dallas | Texas |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | The Dayton Heart Center | Dayton | Ohio |
| United States | Decatur Memorial Hospital | Decatur | Illinois |
| United States | Iowa Heart Center | Des Moines | Iowa |
| United States | Palomar Hospital | Escondido | California |
| United States | Michigan Vascular Center | Flint | Michigan |
| United States | University of Florida | Gainesville | Florida |
| United States | East Carolina University | Greenville | North Carolina |
| United States | Westchester Medical Center | Hawthorne | New York |
| United States | Adventist Midwest Health | Hinsdale | Illinois |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | Mayo Clinic | Jacksonville | Florida |
| United States | St. John's Regional Medical Center | Joplin | Missouri |
| United States | Wilford Hall Medical Center | Lackland Air Force Base | Texas |
| United States | South Central Regional Medical Center | Laurel | Mississippi |
| United States | Leesburg Regional Medical Center | Leesburg | Florida |
| United States | VA Hospital | Little Rock | Arkansas |
| 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 | Wisconsin Heart / Meriter Hospital | Madison | Wisconsin |
| United States | Wellstar Clinical Trials | Marietta | Georgia |
| United States | Oregon | Medford | Oregon |
| United States | Baptist Memorial Hospital | Memphis | Tennessee |
| United States | Cardiac Surgery Associates | Munster | Indiana |
| United States | St. Thomas Hospital | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Columbia University Medical Center | New York | New York |
| United States | Sentara Heart Hospital | Norfolk | Virginia |
| United States | Stanford University VA | Palo Alto | California |
| United States | UPMC Vascular Surgery | Pittsburgh | Pennsylvania |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | William Beaumont Hospital | Royal Oak | Michigan |
| United States | UC Davis Medical Center | Sacramento | California |
| United States | North Central Heart Institute | Sioux Falls | South Dakota |
| United States | Sacred Heart Medical Center | Spokane | Washington |
| United States | Southern Illinois University | Springfield | Illinois |
| United States | Stanford University Medical Center | Stanford | California |
| United States | Staten Island University Hospital | Staten Island | New York |
| United States | University of South Florida | Tampa | Florida |
| United States | Texas | Temple | Texas |
| United States | Jobst Vascular Center | Toledo | Ohio |
| United States | Tucson Vascular Surgery | Tucson | Arizona |
| United States | University of Arizona - UMC | Tucson | Arizona |
| United States | Wake Forest University School of Medicine | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic Cardiovascular | The Cleveland Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Subjects That Experienced Rupture or Aneurysm Related Death | 3 years | ||
| Secondary | Aneurysm Growth >0.5 cm | After repair, AAA enlargement by >0.5cm | 1 year | |
| Secondary | Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up | secondary interventions in those that had successful delivery and deployment by treatment group randomized to. | study termination |
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