Iliac Branch Excluder ReGistry (IceBERG)
NCT02345005 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2026-01-05
Summary
This post market registry consists of a retrospective and a prospective part. The first part is a retrospective registry of all implanted IBE devices of Gore in the Netherlands after CE mark was obtained, to get an initial insight on the feasibility and safety of this procedure. The second part is to prospectively register all data on implanted IBE Gore devices, in order to gain more robust data on the efficacy of the device in maintaining hypogastric artery patency.
Conditions
- Abdominal Aortic Aneurysms
- Common Iliac Aneurysms
- Aneurysm
Interventions
- DEVICE
-
The Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis.
The Gore IBE device is a newly designed iliac branched device, that is used in combination with the widely accepted C3 Excluder endograft, for the exclusion of common iliac aneurysms and aorto-iliac aneurysms.
Sponsors & Collaborators
-
W.L.Gore & Associates
collaborator INDUSTRY -
Rijnstate Hospital
lead OTHER
Principal Investigators
-
Michel Reijnen · Rijnstate Hospital
-
Steven van Sterkenburg · Rijnstate Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2025-07-31
- Completion
- 2025-07-31
Countries
- Italy
- Netherlands
- New Zealand
- Spain
Study Locations
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