Iliac Branch Excluder ReGistry (IceBERG)

NCT02345005 | Completed

• 1 other identifier: 1060-011014
• Study Type: observational
• Target: 100
• Locations: 4 countries
• Sites: 8

Brief 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

Keywords

Vascular diseases; Aneurysm; Treatment Efficacy; Medical device; Population Register

Outcome Measures

Primary Outcomes (2)

• Safety and feasibility of the IBE device

  Primary endpoint of the retrospective part of the registry: \- Safety and feasibility of the Gore IBE implantation up to 30 days, defined as immediate technical success; and complications from procedure up to 30 days

  Procedure and up to 30 days post procedure

• Primary patency of the hypogastric side branch

  Primary endpoint of the prospective part of the registry: Primary patency of the hypogastric side branch at 1 year, and successful exclusion of the aneurysm without type I or II endoleak.

  Up to 1 year postprocedure

Secondary Outcomes (9)

• Primary-assisted patency of the hypogastric branch

  Measured at 1 month, 6 months, 1 year and then yearly up to 5 years

• Secondary patency of the hypogastric branch

  Measured at 1 month, 6 months, 1 year and then yearly up to 5 years

• Buttock claudication

  Measured at 1 month, 6 months, 1 year and then yearly up to 5 years

• Erectile dysfunction

  Measured at 1 month, 6 months, 1 year and then yearly up to 5 years

• Bowel ischemia

  Measured at 1 month, 6 months, 1 year and then yearly up to 5 years

Interventions

The Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis. DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients in whom a Gore IBE was or will be implanted.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead
• W.L.Gore & Associates: collaborator

Study Sites (8)

Fondazione Poliambulanza

Brescia, Italy

Location

Cardarelli Hospital

Naples, Italy

Location

San Filippo Neri Hospital

Rome, Italy

Location

Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands

Location

Elisabeth Hospital

Tilburg, Netherlands

Location

Auckland Hospital

Auckland, New Zealand

Location

Complexo Hospitelario Universitario de Ourense (CHUO)

Ourense, Spain

Location

Hospital Casa de Salud

Valencia, Spain

Location

Related Publications (25)

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• Armon MP, Wenham PW, Whitaker SC, Gregson RH, Hopkinson BR. Common iliac artery aneurysms in patients with abdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 1998 Mar;15(3):255-7. doi: 10.1016/s1078-5884(98)80186-x.

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• Su WT, Stone DH, Lamparello PJ, Rockman CB. Gluteal compartment syndrome following elective unilateral internal iliac artery embolization before endovascular abdominal aortic aneurysm repair. J Vasc Surg. 2004 Mar;39(3):672-5. doi: 10.1016/j.jvs.2003.09.020.

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• Razavi MK, DeGroot M, Olcott C 3rd, Sze D, Kee S, Semba CP, Dake MD. Internal iliac artery embolization in the stent-graft treatment of aortoiliac aneurysms: analysis of outcomes and complications. J Vasc Interv Radiol. 2000 May;11(5):561-6. doi: 10.1016/s1051-0443(07)61606-6.

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• Karch LA, Hodgson KJ, Mattos MA, Bohannon WT, Ramsey DE, McLafferty RB. Adverse consequences of internal iliac artery occlusion during endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2000 Oct;32(4):676-83. doi: 10.1067/mva.2000.109750.

  PMID: 11013030 BACKGROUND

• Yano OJ, Morrissey N, Eisen L, Faries PL, Soundararajan K, Wan S, Teodorescu V, Kerstein M, Hollier LH, Marin ML. Intentional internal iliac artery occlusion to facilitate endovascular repair of aortoiliac aneurysms. J Vasc Surg. 2001 Aug;34(2):204-11. doi: 10.1067/mva.2001.115380.

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• Mehta M, Veith FJ, Ohki T, Cynamon J, Goldstein K, Suggs WD, Wain RA, Chang DW, Friedman SG, Scher LA, Lipsitz EC. Unilateral and bilateral hypogastric artery interruption during aortoiliac aneurysm repair in 154 patients: a relatively innocuous procedure. J Vasc Surg. 2001 Feb;33(2 Suppl):S27-32. doi: 10.1067/mva.2001.111678.

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• Rayt HS, Bown MJ, Lambert KV, Fishwick NG, McCarthy MJ, London NJ, Sayers RD. Buttock claudication and erectile dysfunction after internal iliac artery embolization in patients prior to endovascular aortic aneurysm repair. Cardiovasc Intervent Radiol. 2008 Jul-Aug;31(4):728-34. doi: 10.1007/s00270-008-9319-3. Epub 2008 Mar 13.

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• Bastos Goncalves F, Jairam A, Voute MT, Moelker AD, Rouwet EV, ten Raa S, Hendriks JM, Verhagen HJ. Clinical outcome and morphologic analysis after endovascular aneurysm repair using the Excluder endograft. J Vasc Surg. 2012 Oct;56(4):920-8. doi: 10.1016/j.jvs.2012.03.263. Epub 2012 Jun 15.

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• Pratesi C, Piffaretti G, Pratesi G, Castelli P; ITalian Excluder Registry Investigators. ITalian Excluder Registry and results of Gore Excluder endograft for the treatment of elective infrarenal abdominal aortic aneurysms. J Vasc Surg. 2014 Jan;59(1):52-7.e1. doi: 10.1016/j.jvs.2013.06.067. Epub 2013 Sep 20.

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MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm; Vascular Diseases

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Michel Reijnen

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

• Steven van Sterkenburg

  Rijnstate Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular surgeon

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 26, 2015
• Study Start: November 1, 2014
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

IT (3); ES (2); NL (2); NZ (1)