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 : February 21, 2020
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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:
- Is the technical success rate of successful delivery and deployment of the Endurant (II) similar in anatomically challenging aneurysm?
- 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 |
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 : | May 2023 |

Group/Cohort | Intervention/treatment |
---|---|
Abdominal Aortic Aneurysm (Challenging anatomy)
Endovascular aneurysm repair
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Device: Endurant Stent Graft |
- 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
- Helath Related Quality of Life Scores [ Time Frame: 12 months ]EQ-5D VAS EQ-5D index

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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 |
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
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

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
Netherlands | |
Catharina Ziekenhuis | |
Eindhoven, Noord-Brabant, Netherlands, 5602 ZA |
Responsible Party: | Joep Teijink, MD, PhD, Catharina Ziekenhuis Eindhoven |
ClinicalTrials.gov Identifier: | NCT01810250 |
Other Study ID Numbers: |
EAGLE Registry |
First Posted: | March 13, 2013 Key Record Dates |
Last Update Posted: | February 21, 2020 |
Last Verified: | February 2020 |
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |