Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

Covidien

Status: Completed

Conditions: Aortic Aneurysm, Abdominal

Treatments: Device: Endurant Stent Graft System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01379222

10012289

Details and patient eligibility

About

The purpose of the study is to demonstrate the long term safety and effectiveness of the Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment, through the endpoints established in this protocol.

The clinical objective of the study is to evaluate the long term safety and effectiveness of the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality (ARM).

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Indication for elective surgical repair of abdominal aortic aneurysm (AAA) with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Endurant Stent Graft System
• Signed consent form. The subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information
• Intention to electively implant the Endurant Stent Graft System
• Ability and willingness to comply with the Clinical Investigational Plan (CIP).

Exclusion criteria

• High probability of non-adherence to physician's follow-up requirements
• Current participation in a concurrent trial which may confound study results
• Female of childbearing potential in whom pregnancy cannot be excluded or who is lactating.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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178 participants in 1 patient group

ENGAGE PAS De Novo Subjects

Experimental group

Description:

The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU).

Treatment:

Device: Endurant Stent Graft System