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The (PIVOTAL) Study

NCT00444821 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 728

Last updated 2021-10-11

Study results available
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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.

Conditions

  • ABDOMINAL AORTIC ANEURYSMS

Interventions

DEVICE

AneuRx AAA stent graft / Talent AAA stent graft

Catheter based stent graft inserted to seal off an abdominal aortic aneurysm

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Kenneth Ouriel, MD · New York Presbyterian Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00444821 on ClinicalTrials.gov