The (PIVOTAL) Study

Covidien

Status

Terminated

Conditions

ABDOMINAL AORTIC ANEURYSMS

Treatments

Device: AneuRx AAA stent graft / Talent AAA stent graft

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00444821

VS-2005-01

Details and patient eligibility

About

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.

Enrollment

728 patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

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