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OpenTrials
Completed

NCT Number: NCT01810250

Endurant for Challenging Anatomy: Global Experience Registry

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?

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Key information

Conditions

Abdominal Aortic Aneurysms With Challenging Anatomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina Ziekenhuis

Eindhoven, North Brabant, 5602 ZA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endurant Stent Graft

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. Helath Related Quality of Life Scores

    Time frame: 12 months

    EQ-5D VAS EQ-5D index

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Official study title

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

Acronym: EAGLE

Important dates

Study start
2012
Primary completion
2018
Study completion
2023
First posted
Mar 13, 2013
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.