Rationale and design of the EAGLE Registry: EVAR with Endurant® in challenging anatomy

Abstract

Aim: The aim of this study was to collect clinical information on the performance of the Endurant® (II) Stent Graft System for endovascular repair in anatomically challenging infrarenal aneurysms, and to critically assess whether the current instructions for anatomic eligibility for endovascular treatment with this system are still applicable.

Methods: Initiated by doctors, EAGLE is a prospective, non-interventional study, aiming to enrol 250 patients in 20 experienced centres across several countries worldwide. EAGLE focuses on patients with challenging angulation or neck length. To minimize the risk of selection bias and enhance data quality, EAGLE eligibility will be determined by an independent core-lab and efforts will be made to secure consecutive enrolment of challenging cases. The EAGLE database is designed to merge with the on-going ENGAGE database, which enables comparative analysis of cases and results.

Results: The primary endpoint is treatment success at 30 days, 12 months and yearly up to 5 years postimplant.

Conclusion: Separate studies on the performance of EVAR in challenging anatomy are necessary to demonstrate safety and effectiveness of the latest generation stent-grafts, which is essential in making a balanced judgment about the optimal management of AAAs.