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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02345005




Registration number
NCT02345005
Ethics application status
Date submitted
19/01/2015
Date registered
26/01/2015
Date last updated
21/07/2023

Titles & IDs
Public title
Iliac Branch Excluder ReGistry (IceBERG)
Scientific title
Multi-centre, Observational, Post-market, Real World Registry to Assess Outcomes of Patients Treated With the Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis
Secondary ID [1] 0 0
1060-011014
Universal Trial Number (UTN)
Trial acronym
IceBERG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysms 0 0
Common Iliac Aneurysms 0 0
Aneurysm 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - The Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis.

Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and feasibility of the IBE device
Timepoint [1] 0 0
Procedure and up to 30 days post procedure
Primary outcome [2] 0 0
Primary patency of the hypogastric side branch
Timepoint [2] 0 0
Up to 1 year postprocedure
Secondary outcome [1] 0 0
Primary-assisted patency of the hypogastric branch
Timepoint [1] 0 0
Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary outcome [2] 0 0
Secondary patency of the hypogastric branch
Timepoint [2] 0 0
Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary outcome [3] 0 0
Buttock claudication
Timepoint [3] 0 0
Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary outcome [4] 0 0
Erectile dysfunction
Timepoint [4] 0 0
Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary outcome [5] 0 0
Bowel ischemia
Timepoint [5] 0 0
Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary outcome [6] 0 0
Failure of the IBE device
Timepoint [6] 0 0
Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary outcome [7] 0 0
Freedom from aneurysm rupture
Timepoint [7] 0 0
Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary outcome [8] 0 0
Mortality
Timepoint [8] 0 0
Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary outcome [9] 0 0
Patency
Timepoint [9] 0 0
Measured yearly up to 5 years

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient is participating in another clinical study (RCT; interfering with endpoints)
* Patient's life expectancy <2 years as judged by the investigator
* 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 has a ruptured, leaking, or mycotic aneurysm
* Patient had a CVA or an MI within the prior three months
* Patient is pregnant (Female patients of childbearing potential only)
* Other stents placed in CIA or hypogastric arteries than the Gore® EXCLUDER® iliac branch Endoprosthesis

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Brescia
Country [2] 0 0
Italy
State/province [2] 0 0
Naples
Country [3] 0 0
Italy
State/province [3] 0 0
Rome
Country [4] 0 0
Netherlands
State/province [4] 0 0
Gelderland
Country [5] 0 0
Netherlands
State/province [5] 0 0
Tilburg
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
Spain
State/province [7] 0 0
Ourense
Country [8] 0 0
Spain
State/province [8] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Other
Name
Rijnstate Hospital
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
W.L.Gore & Associates
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michel Reijnen
Address 0 0
Rijnstate Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.