The (PIVOTAL) Study
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 40 - 90 |
| Updated: | 6/1/2018 |
| Start Date: | March 2005 |
| End Date: | January 2010 |
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
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.
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.
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
We found this trial at
65
sites
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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University of Southern California The University of Southern California is one of the world’s leading...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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University of South Florida The University of South Florida is a high-impact, global research university...
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Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Southern Illinois University From its humble beginnings as the state's second teachers college - founded...
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Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Staten Island University Hospital Staten Island University Hospital is a 714-bed, specialized teaching hospital located...
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