Endurant for Challenging Anatomy: Global Experience Registry

EVAR Treatment With the Endurant Stent Graft of Challenging Anatomy in Experienced Hands, the Real World Experience

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01810250

Acronym

EAGLE

Enrollment

150

Registered

2013-03-13

Start date

2012-11-30

Completion date

2023-05-31

Last updated

2023-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysms With Challenging Anatomy

Brief summary

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?

Interventions

DEVICEEndurant Stent Graft

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical success	12 months	Freedom from: * Increase of AAA diameter \> 5 mm (1 month measurement as baseline) * Type I&III endoleaks * Aneurysm rupture * Conversion to surgery * Stent graft migration (\>10mm) resulting in SAE or reintervention * Stent graft occlusion

Secondary

Measure	Time frame	Description
Helath Related Quality of Life Scores	12 months	EQ-5D VAS EQ-5D index

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026