Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)

Medtronic Cardiovascular63 sites in 1 country728 target enrollmentMarch 2005

ConditionsABDOMINAL AORTIC ANEURYSMS

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ABDOMINAL AORTIC ANEURYSMS
Sponsor: Medtronic Cardiovascular
Enrollment: 728
Locations: 63
Primary Endpoint: Number of Subjects That Experienced Rupture or Aneurysm Related Death
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

January 2010

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Cardiovascular

Responsible Party

Sponsor

Eligibility Criteria

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