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
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|
|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|
Abdominal Aortic Aneurysm (Challenging anatomy)
Endovascular aneurysm repair
Device: Endurant Stent Graft
- Clinical success [ Time Frame: 12 months ]
- 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
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
|Eindhoven, Noord-Brabant, Netherlands, 5602 ZA|