Viewing Study NCT01810250


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Study NCT ID: NCT01810250
Status: COMPLETED
Last Update Posted: 2023-12-26
First Post: 2013-02-12
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Endurant for Challenging Anatomy: Global Experience Registry
Sponsor: Catharina Ziekenhuis Eindhoven
Organization:

Study Overview

Official Title: EVAR Treatment With the Endurant Stent Graft of Challenging Anatomy in Experienced Hands, the Real World Experience
Status: COMPLETED
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EAGLE
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?
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: