Clinical trial NCT00444821: The (PIVOTAL) Study
Official title: Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ABDOMINAL AORTIC ANEURYSMS
Keywords: AAA
Aneurysm
AneuRx
Talent
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
First posted: 2007-03-08
Enrollment: 728
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Subjects That Experienced Rupture or Aneurysm Related Death
timeFrame: 3 years
Secondary outcomes:
measure: Aneurysm Growth >0.5 cm
timeFrame: 1 year
measure: Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up
timeFrame: study termination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Tucson
country: United States
facility: Tucson Vascular Surgery
state: Arizona
city: Tucson
country: United States
facility: University of Arizona - UMC
state: Arizona
city: Little Rock
country: United States
facility: VA Hospital
state: Arkansas
city: Escondido
country: United States
facility: Palomar Hospital
state: California
city: Long Beach
country: United States
facility: Long Beach VA Healthcare System
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Palo Alto
country: United States
facility: Stanford University VA
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Leesburg
country: United States
facility: Leesburg Regional Medical Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: St. Joseph's Research Institute
state: Georgia
city: Marietta
country: United States
facility: Wellstar Clinical Trials
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Hinsdale
country: United States
facility: Adventist Midwest Health
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University
state: Illinois
city: Munster
country: United States
facility: Cardiac Surgery Associates
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Ashland
country: United States
facility: Tri-State Vascular Group
state: Kentucky
city: Baton Rouge
country: United States
facility: Vascular Surgery Associates
state: Louisiana
city: Bel Air
country: United States
facility: Vascular Surgery Associates
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Flint
country: United States
facility: Michigan Vascular Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Laurel
country: United States
facility: South Central Regional Medical Center
state: Mississippi
city: Joplin
country: United States
facility: St. John's Regional Medical Center
state: Missouri
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Hawthorne
country: United States
facility: Westchester Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Asheville
country: United States
facility: Mission / St. Joseph Hospital
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Clinical Trials Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Dayton
country: United States
facility: The Dayton Heart Center
state: Ohio
city: Toledo
country: United States
facility: Jobst Vascular Center
state: Ohio
city: Medford
country: United States
facility: Oregon
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Vascular Surgery
state: Pennsylvania
city: Sioux Falls
country: United States
facility: North Central Heart Institute
state: South Dakota
city: Chattanooga
country: United States
facility: University Surgical Associates
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Medical Center
state: Texas
city: Temple
country: United States
facility: Texas
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Heart Hospital
state: Virginia
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Madison
country: United States
facility: Wisconsin Heart / Meriter Hospital
state: Wisconsin
Study officials:
affiliation: New York Presbyterian Hospital
name: Kenneth Ouriel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.