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The (PIVOTAL) Study

Primary Purpose

ABDOMINAL AORTIC ANEURYSMS

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AneuRx AAA stent graft / Talent AAA stent graft
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ABDOMINAL AORTIC ANEURYSMS focused on measuring AAA, Aneurysm, AneuRx, Talent

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Tucson Vascular Surgery
  • University of Arizona - UMC
  • VA Hospital
  • Palomar Hospital
  • Long Beach VA Healthcare System
  • UCLA Medical Center
  • University of Southern California
  • Stanford University VA
  • UC Davis Medical Center
  • Stanford University Medical Center
  • University of Florida
  • Mayo Clinic
  • Leesburg Regional Medical Center
  • University of South Florida
  • St. Joseph's Research Institute
  • Wellstar Clinical Trials
  • University of Chicago
  • Decatur Memorial Hospital
  • Adventist Midwest Health
  • Southern Illinois University
  • Cardiac Surgery Associates
  • Iowa Heart Center
  • Tri-State Vascular Group
  • Vascular Surgery Associates
  • Vascular Surgery Associates
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • University of Michigan
  • Michigan Vascular Center
  • William Beaumont Hospital
  • Mayo Clinic
  • South Central Regional Medical Center
  • St. John's Regional Medical Center
  • Albany Medical Center
  • Westchester Medical Center
  • Columbia University Medical Center
  • Staten Island University Hospital
  • Mission / St. Joseph Hospital
  • University of North Carolina
  • Presbyterian Hospital
  • East Carolina University
  • Wake Forest University School of Medicine
  • The Lindner Clinical Trials Center
  • Cleveland Clinic Foundation
  • Ohio State University
  • The Dayton Heart Center
  • Jobst Vascular Center
  • Oregon
  • Lehigh Valley Hospital
  • UPMC Vascular Surgery
  • North Central Heart Institute
  • University Surgical Associates
  • Baptist Memorial Hospital
  • St. Thomas Hospital
  • Vanderbilt University Medical Center
  • Methodist Dallas Medical Center
  • UT Southwestern Medical Center
  • Baylor College of Medicine
  • Wilford Hall Medical Center
  • Texas
  • University of Virginia
  • Sentara Heart Hospital
  • Sacred Heart Medical Center
  • Wisconsin Heart / Meriter Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Surveillance

Early Endovascular Repair

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects That Experienced Rupture or Aneurysm Related Death

Secondary Outcome Measures

Aneurysm Growth >0.5 cm
After repair, AAA enlargement by >0.5cm
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.

Full Information

First Posted
March 6, 2007
Last Updated
October 7, 2021
Sponsor
Medtronic Cardiovascular
Collaborators
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00444821
Brief Title
The (PIVOTAL) Study
Official Title
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis of Primary Endpoint completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular
Collaborators
The Cleveland Clinic

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ABDOMINAL AORTIC ANEURYSMS
Keywords
AAA, Aneurysm, AneuRx, Talent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
728 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surveillance
Arm Type
No Intervention
Arm Title
Early Endovascular Repair
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AneuRx AAA stent graft / Talent AAA stent graft
Intervention Description
Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
Primary Outcome Measure Information:
Title
Number of Subjects That Experienced Rupture or Aneurysm Related Death
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Aneurysm Growth >0.5 cm
Description
After repair, AAA enlargement by >0.5cm
Time Frame
1 year
Title
Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up
Description
secondary interventions in those that had successful delivery and deployment by treatment group randomized to.
Time Frame
study termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Ouriel, MD
Organizational Affiliation
New York Presbyterian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Tucson Vascular Surgery
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
University of Arizona - UMC
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
VA Hospital
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Palomar Hospital
City
Escondido
State/Province
California
Country
United States
Facility Name
Long Beach VA Healthcare System
City
Long Beach
State/Province
California
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Stanford University VA
City
Palo Alto
State/Province
California
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Leesburg Regional Medical Center
City
Leesburg
State/Province
Florida
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
Country
United States
Facility Name
St. Joseph's Research Institute
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Wellstar Clinical Trials
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
Country
United States
Facility Name
Adventist Midwest Health
City
Hinsdale
State/Province
Illinois
Country
United States
Facility Name
Southern Illinois University
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Cardiac Surgery Associates
City
Munster
State/Province
Indiana
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
Tri-State Vascular Group
City
Ashland
State/Province
Kentucky
Country
United States
Facility Name
Vascular Surgery Associates
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Vascular Surgery Associates
City
Bel Air
State/Province
Maryland
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Michigan Vascular Center
City
Flint
State/Province
Michigan
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
South Central Regional Medical Center
City
Laurel
State/Province
Mississippi
Country
United States
Facility Name
St. John's Regional Medical Center
City
Joplin
State/Province
Missouri
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
Country
United States
Facility Name
Westchester Medical Center
City
Hawthorne
State/Province
New York
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Mission / St. Joseph Hospital
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
The Lindner Clinical Trials Center
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
The Dayton Heart Center
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Jobst Vascular Center
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Oregon
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
UPMC Vascular Surgery
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
North Central Heart Institute
City
Sioux Falls
State/Province
South Dakota
Country
United States
Facility Name
University Surgical Associates
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
St. Thomas Hospital
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
Country
United States
Facility Name
Wilford Hall Medical Center
City
Lackland Air Force Base
State/Province
Texas
Country
United States
Facility Name
Texas
City
Temple
State/Province
Texas
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Sentara Heart Hospital
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Sacred Heart Medical Center
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Wisconsin Heart / Meriter Hospital
City
Madison
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23562339
Citation
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.
Results Reference
derived

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The (PIVOTAL) Study

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