Completed

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

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What is being collected

Device Data

Collected from today forward - Prospective
Device
Who is being recruted

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: November 2012
See protocol details

Summary

Principal SponsorCatharina Ziekenhuis Eindhoven
Last updated: December 26, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01810250
Principal SponsorCatharina Ziekenhuis Eindhoven
Last updated: December 26, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Age >= 18 years or minimum age as required by local regulations
Challenging AAA anatomy
Indication for elective EVAR
Intention to electively implant the Endurant or Endurant II Stent Graft System
Show More Criteria
4 exclusion criteria prevent from participating
Chimneys or fenestrated device procedures
Current participation in a concurrent trial that may confound study results
High probability of non-adherence to physician's follow-up requirements
Subjects with intolerance to contrast media

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Catharina Ziekenhuis

Eindhoven, NetherlandsOpen Catharina Ziekenhuis in Google Maps
CompletedOne Study Center