Endurant for Challenging Anatomy: Global Experience Registry

Completed

• Conditions: Abdominal Aortic Aneurysms With Challenging Anatomy
• Interventions: Device: Endurant Stent Graft

• Registration Number: NCT01810250
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Primary Completion: 2018-01
• Study Completion: 2023-05
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abdominal Aortic Aneurysm (Challenging anatomy)	Endurant Stent Graft	Endovascular aneurysm repair

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Helath Related Quality of Life Scores	12 months	EQ-5D VAS EQ-5D index

Trial Locations

Locations (1)

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands