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Endurant for Challenging Anatomy: Global Experience Registry

NCT ID: NCT01810250

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2023-05-31

Brief Summary

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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?

Detailed Description

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Conditions

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Abdominal Aortic Aneurysms With Challenging Anatomy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Abdominal Aortic Aneurysm (Challenging anatomy)

Endovascular aneurysm repair

Endurant Stent Graft

Intervention Type DEVICE

Interventions

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Endurant Stent Graft

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role lead

Responsible Party

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Joep Teijink

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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EAGLE Registry

Identifier Type: -

Identifier Source: org_study_id