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AneuRx Post Market Study in the Treatment of AAA

NCT ID: NCT00604552

Last Updated: 2021-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

349 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2009-02-28

Brief Summary

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The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. Abdominal aortic aneurysm (AAA) is a life-threatening lesion that has been treated in recent year via endovascular repair.

The purpose of this study is to monitor the long term performance of the AneuRx Stent Graft Systems.

Detailed Description

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Conditions

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Abdominal Aneurysm

Keywords

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Abdominal Aneurysm Endovascular Aortic Repair (EVAR) Endovascular Stent Graft Endograft

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lifeline Registry

All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)

Group Type OTHER

AneuRx Stent Graft

Intervention Type DEVICE

Abdominal Aortic Aneurysm Repair

PS Registry

All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic

Group Type OTHER

AneuRx Stent Graft

Intervention Type DEVICE

Abdominal Aortic Aneurysm Repair

Interventions

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AneuRx Stent Graft

Abdominal Aortic Aneurysm Repair

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients implanted with an AneuRx Stent Graft per Instructions for Use
* Patients must provide written informed consent and agree to be accessible for follow-up at the study center.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medtronic Cardiovascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medtronic Cardiovascular

Role: STUDY_CHAIR

Medtronic

Locations

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Tucson, Arizona, United States

Site Status

Royal Oak, Michigan, United States

Site Status

Morristown, New Jersey, United States

Site Status

Asheville, North Carolina, United States

Site Status

Chapel Hill, North Carolina, United States

Site Status

Sioux Falls, South Dakota, United States

Site Status

Memphis, Tennessee, United States

Site Status

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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PS01000010

Identifier Type: -

Identifier Source: org_study_id