Status:
TERMINATED
The (PIVOTAL) Study
Lead Sponsor:
Medtronic Cardiovascular
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
ABDOMINAL AORTIC ANEURYSMS
Eligibility:
All Genders
40-90 years
Phase:
NA
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
728 Patients enrolled
Trial Details
Trial ID
NCT00444821
Start Date
March 1 2005
End Date
January 1 2010
Last Update
October 11 2021
Active Locations (65)
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1
University of Alabama
Birmingham, Alabama, United States
2
Tucson Vascular Surgery
Tucson, Arizona, United States
3
University of Arizona - UMC
Tucson, Arizona, United States
4
VA Hospital
Little Rock, Arkansas, United States