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Endurant for Challenging Anatomy: Global Experience Registry (EAGLE)

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ClinicalTrials.gov Identifier: NCT01810250
Recruitment Status : Active, not recruiting
First Posted : March 13, 2013
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Joep Teijink, 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?

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysms With Challenging Anatomy Device: Endurant Stent Graft

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Study Type : Observational [Patient Registry]
Actual Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: EVAR Treatment With the Endurant Stent Graft of Challenging Anatomy in Experienced Hands, the Real World Experience
Study Start Date : November 2012
Actual Primary Completion Date : January 2018
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  1. Helath Related Quality of Life Scores [ Time Frame: 12 months ]
    EQ-5D VAS EQ-5D index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810250


Locations
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Netherlands
Catharina Ziekenhuis
Eindhoven, Noord-Brabant, Netherlands, 5602 ZA
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven

Additional Information:
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Responsible Party: Joep Teijink, MD, PhD, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT01810250     History of Changes
Other Study ID Numbers: EAGLE Registry
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases