The (PIVOTAL) Study
October 7, 2021 updated by: Medtronic Cardiovascular
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
728
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
- University of Alabama
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Arizona
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Tucson, Arizona, United States
- Tucson Vascular Surgery
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Tucson, Arizona, United States
- University of Arizona - UMC
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Arkansas
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Little Rock, Arkansas, United States
- VA Hospital
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California
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Escondido, California, United States
- Palomar Hospital
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Long Beach, California, United States
- Long Beach VA Healthcare System
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Los Angeles, California, United States
- University of Southern California
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Los Angeles, California, United States
- UCLA Medical Center
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Palo Alto, California, United States
- Stanford University VA
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Sacramento, California, United States
- UC Davis Medical Center
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Stanford, California, United States
- Stanford University Medical Center
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Florida
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Gainesville, Florida, United States
- University of Florida
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Jacksonville, Florida, United States
- Mayo Clinic
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Leesburg, Florida, United States
- Leesburg Regional Medical Center
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Tampa, Florida, United States
- University of South Florida
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Georgia
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Atlanta, Georgia, United States
- St. Joseph's Research Institute
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Marietta, Georgia, United States
- Wellstar Clinical Trials
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Illinois
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Chicago, Illinois, United States
- University of Chicago
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Decatur, Illinois, United States
- Decatur Memorial Hospital
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Hinsdale, Illinois, United States
- Adventist Midwest Health
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Springfield, Illinois, United States
- Southern Illinois University
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Indiana
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Munster, Indiana, United States
- Cardiac Surgery Associates
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Iowa
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Des Moines, Iowa, United States
- Iowa Heart Center
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Kentucky
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Ashland, Kentucky, United States
- Tri-State Vascular Group
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Louisiana
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Baton Rouge, Louisiana, United States
- Vascular Surgery Associates
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Maryland
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Bel Air, Maryland, United States
- Vascular Surgery Associates
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Massachusetts
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Boston, Massachusetts, United States
- Massachusetts General Hospital
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Boston, Massachusetts, United States
- Brigham and Women's Hospital
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Michigan
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Ann Arbor, Michigan, United States
- University of Michigan
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Flint, Michigan, United States
- Michigan Vascular Center
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Royal Oak, Michigan, United States
- William Beaumont Hospital
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Minnesota
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Rochester, Minnesota, United States
- Mayo Clinic
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Mississippi
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Laurel, Mississippi, United States
- South Central Regional Medical Center
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Missouri
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Joplin, Missouri, United States
- St. John's Regional Medical Center
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New York
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Albany, New York, United States
- Albany Medical Center
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Hawthorne, New York, United States
- Westchester Medical Center
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New York, New York, United States
- Columbia University Medical Center
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Staten Island, New York, United States
- Staten Island University Hospital
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North Carolina
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Asheville, North Carolina, United States
- Mission / St. Joseph Hospital
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Chapel Hill, North Carolina, United States
- University of North Carolina
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Charlotte, North Carolina, United States
- Presbyterian Hospital
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Greenville, North Carolina, United States
- East Carolina University
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Winston-Salem, North Carolina, United States
- Wake Forest University School of Medicine
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Ohio
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Cincinnati, Ohio, United States
- The Lindner Clinical Trials Center
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Cleveland, Ohio, United States
- Cleveland Clinic Foundation
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Columbus, Ohio, United States
- Ohio State University
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Dayton, Ohio, United States
- The Dayton Heart Center
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Toledo, Ohio, United States
- Jobst Vascular Center
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Oregon
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Medford, Oregon, United States
- Oregon
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Pennsylvania
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Allentown, Pennsylvania, United States
- LeHigh Valley Hospital
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Pittsburgh, Pennsylvania, United States
- UPMC Vascular Surgery
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South Dakota
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Sioux Falls, South Dakota, United States
- North Central Heart Institute
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Tennessee
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Chattanooga, Tennessee, United States
- University Surgical Associates
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Memphis, Tennessee, United States
- Baptist Memorial Hospital
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Nashville, Tennessee, United States
- St. Thomas Hospital
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Nashville, Tennessee, United States
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, United States
- UT Southwestern Medical Center
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Dallas, Texas, United States
- Methodist Dallas Medical Center
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Houston, Texas, United States
- Baylor College of Medicine
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Lackland Air Force Base, Texas, United States
- Wilford Hall Medical Center
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Temple, Texas, United States
- Texas
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Virginia
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Charlottesville, Virginia, United States
- University of Virginia
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Norfolk, Virginia, United States
- Sentara Heart Hospital
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Washington
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Spokane, Washington, United States
- Sacred Heart Medical Center
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Wisconsin
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Madison, Wisconsin, United States
- Wisconsin Heart / Meriter Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Surveillance
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|
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Experimental: Early Endovascular Repair
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Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Subjects That Experienced Rupture or Aneurysm Related Death
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aneurysm Growth >0.5 cm
Time Frame: 1 year
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After repair, AAA enlargement by >0.5cm
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1 year
|
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Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up
Time Frame: study termination
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secondary interventions in those that had successful delivery and deployment by treatment group randomized to.
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study termination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth Ouriel, MD, New York Presbyterian Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
March 6, 2007
First Submitted That Met QC Criteria
March 7, 2007
First Posted (Estimate)
March 8, 2007
Study Record Updates
Last Update Posted (Actual)
October 11, 2021
Last Update Submitted That Met QC Criteria
October 7, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VS-2005-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.