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The (PIVOTAL) Study | Clinical Trials | Clareo Health

TERMINATEDNA

The (PIVOTAL) Study

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

NCT00444821•Medtronic Cardiovascular

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.

Eligibility

Age

40 - 90 years

Sex

ALL

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

Locations (65)

University of Alabama

Birmingham, Alabama, United States

Tucson Vascular Surgery

Tucson, Arizona, United States

University of Arizona - UMC

Tucson, Arizona, United States

VA Hospital

Little Rock, Arkansas, United States

Palomar Hospital

Escondido, California, United States

Long Beach VA Healthcare System

Long Beach, California, United States

UCLA Medical Center

Los Angeles, California, United States

University of Southern California

Los Angeles, California, United States

Stanford University VA

Palo Alto, California, United States

UC Davis Medical Center

Sacramento, California, United States

Key Dates

Start Date

March 1, 2005

Primary Completion Date

January 1, 2010

Completion Date

January 1, 2010

Last Updated

October 11, 2021

Enrollment

728

ACTUAL participants

Conditions

ABDOMINAL AORTIC ANEURYSMS

Interventions

AneuRx AAA stent graft / Talent AAA stent graft

DEVICE

Investigating Practice Patterns in Symptomatic Non-ruptured Abdominal Aortic Aneurysms (AAA) in Europe

NCT07184723

Symptomatic Non-ruptured Abdominal Aortic Aneurysms

View study

RECRUITINGNA

Thoracoabdominal Artery Stent Graft System Exploratory Study

NCT06710938

Thoracoabdominal Aortic Aneurysms

View study

RECRUITING

Use of Artificial Intelligence to Predict Complications Following Abdominal Aortic Surgery

NCT06884397

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 11, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The (PIVOTAL) Study

Inclusion Criteria

Exclusion Criteria

Investigating Practice Patterns in Symptomatic Non-ruptured Abdominal Aortic Aneurysms (AAA) in Europe

Thoracoabdominal Artery Stent Graft System Exploratory Study

Use of Artificial Intelligence to Predict Complications Following Abdominal Aortic Surgery

Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms

Validation of Fenestrations Positioning by Numerical Simulation