Endurant for Challenging Anatomy: Global Experience Registry (EAGLE)

Catharina Hospital

Status: Completed

Conditions: Abdominal Aortic Aneurysms With Challenging Anatomy

Treatments: Device: Endurant Stent Graft

Study type: Observational

Funder types: Other

Identifiers

NCT01810250

EAGLE Registry

Details and patient eligibility

About

The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this study is to collect clinical information on the performance of the Endurant Stent Graft System for endovascular repair in anatomically challenging aneurysms, and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable. This study aims at creating a database that can be pooled/ compared with the ENGAGE database.

This study aims at answering two major questions:

1. Is the technical success rate of successful delivery and deployment of the Endurant (II) similar in anatomically challenging aneurysm?
2. Is the successful treatment rate comparable in anatomically challenging aneurysms, or does treatment of these aneurysms lead to more complications and reinterventions?

Enrollment: 150 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 EVAR
• Challenging AAA anatomy
• Intention to electively implant the Endurant or Endurant II Stent Graft System©
• Signed informed consent form

Exclusion criteria

• Subjects with intolerance to contrast media
• Chimneys or fenestrated device procedures
• High probability of non-adherence to physician's follow-up requirements
• Current participation in a concurrent trial that may confound study results

Trial design

150 participants in 1 patient group

Abdominal Aortic Aneurysm (Challenging anatomy)

Description:

Endovascular aneurysm repair

Treatment:

Device: Endurant Stent Graft