Brief Title
The (PIVOTAL) Study
Official Title
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
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.
Study Type
Interventional
Primary Outcome
Number of Subjects That Experienced Rupture or Aneurysm Related Death
Secondary Outcome
Aneurysm Growth >0.5 cm
Condition
ABDOMINAL AORTIC ANEURYSMS
Intervention
AneuRx AAA stent graft / Talent AAA stent graft
Study Arms / Comparison Groups
Surveillance
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
728
Start Date
March 2005
Completion Date
January 2010
Primary Completion Date
January 2010
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
Gender
All
Ages
40 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Kenneth Ouriel, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00444821
Organization ID
VS-2005-01
Responsible Party
Sponsor
Study Sponsor
Medtronic Cardiovascular
Collaborators
The Cleveland Clinic
Study Sponsor
Kenneth Ouriel, MD, Principal Investigator, New York Presbyterian Hospital
Verification Date
October 2021