Study Stopped
Interim analysis of Primary Endpoint completed
The (PIVOTAL) Study
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
1 other identifier
interventional
728
1 country
65
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2005
Longer than P75 for not_applicable
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 6, 2007
CompletedFirst Posted
Study publicly available on registry
March 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
April 23, 2018
CompletedOctober 11, 2021
October 1, 2021
4.8 years
March 6, 2007
December 21, 2017
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects That Experienced Rupture or Aneurysm Related Death
3 years
Secondary Outcomes (2)
Aneurysm Growth >0.5 cm
1 year
Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up
study termination
Study Arms (2)
Surveillance
NO INTERVENTIONEarly Endovascular Repair
EXPERIMENTALInterventions
Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Eligibility Criteria
You may qualify if:
- 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
- Patient is willing and able to comply with the specified follow-up evaluation
- Life expectancy at least 3 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Cardiovascularlead
- The Cleveland Cliniccollaborator
Study Sites (65)
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
Related Publications (1)
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.
PMID: 23562339DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Terminated before subjects enrolled \& completed follow-up, leading to small numbers. Crossover from the Surveillance Group to Early Endovascular Group led to subjects treated endovascularly being included in the Surveillance Group results.
Results Point of Contact
- Title
- Kristel Wittebols
- Organization
- Medtronic
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Ouriel, MD
New York Presbyterian Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2007
First Posted
March 8, 2007
Study Start
March 1, 2005
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
October 11, 2021
Results First Posted
April 23, 2018
Record last verified: 2021-10