Iliac Branch Excluder ReGistry (IceBERG)

NCT02345005 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-01-05

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02345005 on ClinicalTrials.gov