The (PIVOTAL) Study

Not Recruiting

Trial ID: NCT00444821

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)

Stanford Investigator(s)

Ronald L. Dalman MD
Ronald L. Dalman MD

Dr. Walter C. Chidester Professor

Eligibility

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

Intervention(s):

device: AneuRx AAA stent graft / Talent AAA stent graft

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jason Lee
6507255227