The (PIVOTAL) Study

Stopped early · Not applicable

Conditions studied: ABDOMINAL AORTIC ANEURYSMS

In brief

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.

Key facts

Study ID

NCT00444821

Run by

Medtronic Cardiovascular

People needed

728

Starts

2005-03-01

Expected to finish

2010-01-01

Last updated by the study team

2021-10-11

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• 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
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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