Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE)

Covidien

Status: Completed

Conditions: Aortic Aneurysm, Abdominal

Treatments: Device: Endurant Stent Graft

Study type: Observational

Funder types: Industry

Identifiers

NCT00870051

P#888

Details and patient eligibility

About

The purpose of ENGAGE is to prospectively collect global 'real world' data on the Endurant Stent Graft System from AAA subjects.

Full description

The Endurant Stent Graft Natural Selection Global Post-market Registry, ENGAGE is initiated to expand the clinical knowledge base by including 'real world' subjects, applying a minimal amount of subject selection criteria. This subject group may better represent the subject profile treated in actual clinical practice without selecting sub-groups of particular low/high risk or excluding certain diseases. ENGAGE aims at following and documenting the subject selections, diagnostic tools used and treatment interventions chosen by the vascular surgeon or interventional radiologist. ENGAGE will not impose CIP required study procedures affecting clinical practice.

Enrollment: 1,266 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years or minimum age as required by local regulations
• Indication for elective surgical repair of 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 ("Patient informed consent Form" or "Patient Data Release Authorization 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 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

Trial design

1,266 participants in 1 patient group

AAA patients

Description:

Subjects diagnosed with an AAA who are considered candidates for endovascular repair with Endurant Stent Graft, and who meet the inclusion/exclusion criteria are intended to participate in this registry

Treatment:

Device: Endurant Stent Graft