CompletedNo phase
Iliac Branch Excluder ReGistry (IceBERG)
Key facts
- Who runs it
- Rijnstate Hospital
- Where
- Italy, Netherlands, New Zealand, and Spain8 sites in 4 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 100 people enrolled
- Started
- Nov 2014
- Ended
- Jul 2025
- Type of study
- Observational
- Treatments tested
- The Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis.
- Record updated
- 5 January 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Age 18 years or older
- Provided written informed consent for data release
- Elective procedure; Indication for aorto-iliac endovascular stent graft repair, as determined by the treating physician
Who cannot take part
- Patient had a CVA or an MI within the prior three months
- Patient has a psychiatric or other condition that may interfere with the study
- Patient has a known allergy to any device component (ePTFE, FEP, nitinol)
- Patients with a systemic infection who may be at increased risk of endovascular graft infection
- Patient has a coagulopathy or uncontrolled bleeding disorder
- Patient's life expectancy <2 years as judged by the investigator
- Patient is participating in another clinical study (RCT; interfering with endpoints)
- Patient has a ruptured, leaking, or mycotic aneurysm
- Patient is pregnant (Female patients of childbearing potential only)
- Other stents placed in CIA or hypogastric arteries than the Gore® EXCLUDER® iliac branch Endoprosthesis
This trial has no sites in United States.
It has sites in 4 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Treatments tested
- The Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Multi-centre, Observational, Post-market, Real World Registry to Assess Outcomes of Patients Treated With the Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis
- Record updated
- 5 January 2026