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


CONCLUSIONS
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.
Department of Vascular Surgery Catharina Hospital, Eindhoven, the Netherlands - joep.teijink@catharinaziekenhuis.nl.
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Stokmans
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Broos
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Cuypers
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Forbes
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Vahl
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Van Sambeek
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Teijink
D017544:Aortic Aneurysm, Abdominal / Q000175:diagnosis / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D016208:Databases, Factual; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D012107:Research Design; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome