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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- device : AneuRx AAA stent graft / Talent AAA stent graft
Phase: Phase 4
Ages Eligible For Study:
- 40 to 90 years of age - Meet all indications for use as stated in the Medtronic Vascular AAA Endograft Instructions for Use - 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