Endurant for Challenging Anatomy: Global Experience Registry (EAGLE)

December 20, 2023 updated by: Joep Teijink, Catharina Ziekenhuis Eindhoven

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5602 ZA
        • Catharina Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with abdominal aortic aneurysms (AAAs) with challenging anatomy defined by having one or more of the following measurements:

  • Proximal necks 5 - 10mm in combination with < 60 degrees infrarenal AND < 45 degrees suprarenal angulation
  • Proximal necks 10 - 15mm in combination with 60 degrees - 75 degrees infrarenal AND < 60 degrees suprarenal angulation OR in combination with < 75 degrees infrarenal AND 45 degrees - 60 degrees suprarenal angulation
  • Proximal necks > 15mm in combination with 75 degrees - 90 degrees infrarenal AND < 75 degrees suprarenal angulation OR in combination with < 90 degrees infrarenal AND 60 degrees - 75 degrees suprarenal angulation

Description

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

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Abdominal Aortic Aneurysm (Challenging anatomy)
Endovascular aneurysm repair
Device: Endurant Stent Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success
Time Frame: 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
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catharina Ziekenhuis Eindhoven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

February 12, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimated)

March 13, 2013

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAGLE Registry

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abdominal Aortic Aneurysms With Challenging Anatomy

Clinical Trials on Endurant Stent Graft

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe