©2024 Stanford Medicine
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
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