The (PIVOTAL) Study
Trial ID or NCT#
NCT00444821
Status
NOT RECRUITING
Purpose
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.
Official Title
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
Eligibility Criteria
Ages Eligible for Study: 40 Years to 90 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Jason Lee
6507255227
View on ClinicalTrials.gov
