Trial Search Results

The (PIVOTAL) Study

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 currently not accepting patients for this trial.

Lead Sponsor:

Medtronic Cardiovascular

Collaborator: The Cleveland Clinic

Stanford Investigator(s):


  • Device: AneuRx AAA stent graft / Talent AAA stent graft




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

   - Planned conduit procedure for introduction of endograft

Ages Eligible for Study

40 Years - 90 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jason Lee
Not Recruiting