Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-31 @ 9:56 AM
Study NCT ID:
NCT06972095
Status:
COMPLETED
Last Update Posted:
2025-05-20
First Post:
2025-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Performance of the Endurant Endoprosthesis in an Infrarenal Aortic Aneurysm With a Wide or Conical Shaped Infrarenal Neck Anatomy
Sponsor:
Rijnstate Hospital
Organization:
Study Overview
Official Title:
The Performance of the Endurant Endoprosthesis in an Infrarenal Aortic Aneurysm With a Wide or Conical Shaped Infrarenal Neck Anatomy
Status:
COMPLETED
Status Verified Date:
2025-05
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:
Endurant_WCN
Brief Summary:
Retrospective single centre observational cohort study of patients who underwent an elective infrarenal abdominal aortic aneurysm repair, from January 2011 to January 2020.
Detailed Description:
Objective: To evaluate the performance of the Endurant endoprothesis in patients with a wide or conical shaped neck anatomy after elective abdominal aortic aneurysm repair.
Inclusion: Patients who underwent elective infrarenal abdominal aortic aneurysm repair with the Endurant endograft between January 2011 until January 2020 in Rijnstate, Arnhem, the Netherlands.
Primary endpoint: Freedom from reinterventions at one year.
Secondary outcomes:
* Endoleaks
* Aneurysm sac growth
* Aneurysm rupture
* Stent migration
* AAA-related mortality
* All-cause mortality
* Procedural time
* 30-day complications
* Renal dysfunction/renal occlusion
* Proximal fixation failure
Inclusion: Patients who underwent elective infrarenal abdominal aortic aneurysm repair with the Endurant endograft between January 2011 until January 2020 in Rijnstate, Arnhem, the Netherlands.
Primary endpoint: Freedom from reinterventions at one year.
Secondary outcomes:
* Endoleaks
* Aneurysm sac growth
* Aneurysm rupture
* Stent migration
* AAA-related mortality
* All-cause mortality
* Procedural time
* 30-day complications
* Renal dysfunction/renal occlusion
* Proximal fixation failure
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: