Endurant for Challenging Anatomy: Global Experience Registry

NCT01810250 | Completed

• 1 other identifier: EAGLE Registry
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Abdominal Aortic Aneurysms With Challenging Anatomy

Outcome Measures

Primary Outcomes (1)

• Clinical success

  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 Outcomes (1)

• Helath Related Quality of Life Scores

  12 months

Study Arms (1)

Abdominal Aortic Aneurysm (Challenging anatomy)

Endovascular aneurysm repair

Device: Endurant Stent Graft

Interventions

Endurant Stent Graft DEVICE

Abdominal Aortic Aneurysm (Challenging anatomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Ziekenhuis

Eindhoven, North Brabant, 5602 ZA, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: March 13, 2013
• Study Start: November 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: May 1, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

NL (1)