AneuRx Post Market Study in the Treatment of AAA

Covidien

Status: Terminated

Conditions: Abdominal Aneurysm

Treatments: Device: AneuRx Stent Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT00604552

PS01000010

Details and patient eligibility

About

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.

Enrollment: 349 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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349 participants in 2 patient groups

Lifeline Registry

Other group

Description:

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)

Treatment:

Device: AneuRx Stent Graft

PS Registry

Other group

Description:

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

Treatment:

Device: AneuRx Stent Graft