The (PIVOTAL) Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Abdominal Aortic Aneurysms	Device: AneuRx AAA stent graft / Talent AAA stent graft	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm

U.S. FDA Resources

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:

To determine whether repair of small aneurysms is superior to surveillance with respect to the frequency of rupture or aneurysm related deaths. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Aneurysm shrinkage or growth [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary endovascular procedures between the 30-day post treatment and 1-year follow-up. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	728
Study Start Date:	March 2005
Study Completion Date:	January 2010
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Catheter based stent graft inserted to seal off an abdominal aortic aneurysm

Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

40 to 90 years of age
Meet all indications for use as stated in the Medtronic Vascular AAA Endograft Instructions for Use
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444821

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Locations

United States, Alabama
University of Alabama
Birmingham, Alabama, United States
United States, Arizona
Tucson Vascular Surgery
Tucson, Arizona, United States
University of Arizona - UMC
Tucson, Arizona, United States
United States, Arkansas
VA Hospital
Little Rock, Arkansas, United States
United States, California
Palomar Hospital
Escondido, California, United States
Long Beach VA Healthcare System
Long Beach, California, United States
University of Southern California
Los Angeles, California, United States
UCLA Medical Center
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
United States, Florida
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
United States, Georgia
St. Joseph's Research Institute
Atlanta, Georgia, United States
Wellstar Clinical Trials
Marrietta, Georgia, United States
United States, Illinois
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
United States, Indiana
Cardiac Surgery Associates
Munster, Indiana, United States
United States, Iowa
Iowa Heart Center
Des Moines, Iowa, United States
United States, Kentucky
Tri-State Vascular Group
Ashland, Kentucky, United States
United States, Louisiana
Vascular Surgery Associates
Baton Rouge, Louisiana, United States
United States, Maryland
Vascular Surgery Associates
Bel Air, Maryland, United States
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
Michigan Vascular Center
Flint, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States
United States, Mississippi
South Central Regional Medical Center
Laurel, Mississippi, United States
United States, Missouri
St. John's Regional Medical Center
Joplin, Missouri, United States
United States, New York
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
United States, North Carolina
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
United States, Ohio
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
United States, Oregon
Oregon
Medford, Oregon, United States
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
UPMC Vascular Surgery
Pittsburgh, Pennsylvania, United States
United States, South Dakota
North Central Heart Institute
Sioux Falls, South Dakota, United States
United States, Tennessee
University Surgical Associates
Charttanooga, 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
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States
Methodist Dallas 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
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States
Sentara Heart Hospital
Norfolk, Virginia, United States
United States, Washington
Sacred Heart Medical Center
Spokane, Washington, United States
United States, Wisconsin
Wisconsin Heart / Meriter Hospital
Madison, Wisconsin, United States

Sponsors and Collaborators

Medtronic Vascular

The Cleveland Clinic

Investigators

Principal Investigator:

Kenneth Ouriel, MD

New York Presbyterian Hospital

More Information

No publications provided

Responsible Party:	Simona Zanetti, MD / VP of Clinical Research, Medtronic Vascular
ClinicalTrials.gov Identifier:	NCT00444821 History of Changes
Other Study ID Numbers:	VS-2005-01
Study First Received:	March 6, 2007
Last Updated:	February 4, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Medtronic Vascular:

AAA
Aneurysm
AneuRx
Talent

Additional relevant MeSH terms:

Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 21, 2013