The (PIVOTAL) Study
Trial ID or NCT#
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.
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
- - 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
- - 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
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