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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]

1060-011014

Universal Trial Number (UTN)

Trial acronym

IceBERG

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Abdominal Aortic Aneurysms

Common Iliac Aneurysms

Aneurysm

Condition category

Condition code

Cardiovascular

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]

Treatment: Devices

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Safety and feasibility of the IBE device

Timepoint [1]

Procedure and up to 30 days post procedure

Primary outcome [2]

Primary patency of the hypogastric side branch

Timepoint [2]

Up to 1 year postprocedure

Secondary outcome [1]

Primary-assisted patency of the hypogastric branch

Timepoint [1]

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

Secondary outcome [2]

Secondary patency of the hypogastric branch

Timepoint [2]

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

Secondary outcome [3]

Buttock claudication

Timepoint [3]

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

Secondary outcome [4]

Erectile dysfunction

Timepoint [4]

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

Secondary outcome [5]

Bowel ischemia

Timepoint [5]

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

Secondary outcome [6]

Failure of the IBE device

Timepoint [6]

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

Secondary outcome [7]

Freedom from aneurysm rupture

Timepoint [7]

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

Secondary outcome [8]

Mortality

Timepoint [8]

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

Secondary outcome [9]

Patency

Timepoint [9]

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

1/11/2014

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/07/2025

Actual

Sample size

Target

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Brescia

Country [2]

Italy

State/province [2]

Naples

Country [3]

Italy

State/province [3]

Rome

Country [4]

Netherlands

State/province [4]

Gelderland

Country [5]

Netherlands

State/province [5]

Tilburg

Country [6]

New Zealand

State/province [6]

Auckland

Country [7]

Spain

State/province [7]

Ourense

Country [8]

Spain

State/province [8]

Valencia

Funding & Sponsors

Primary sponsor type

Other

Name

Rijnstate Hospital

Address

Country

Other collaborator category [1]

Commercial sector/industry

Name [1]

W.L.Gore & Associates

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT02345005

Trial related presentations / publications

Blankensteijn JD, de Jong SE, Prinssen M, van der Ham AC, Buth J, van Sterkenburg SM, Verhagen HJ, Buskens E, Grobbee DE; Dutch Randomized Endovascular Aneurysm Management (DREAM) Trial Group. Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2005 Jun 9;352(23):2398-405. doi: 10.1056/NEJMoa051255.
EVAR trial participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial. Lancet. 2005 Jun 25-Jul 1;365(9478):2179-86. doi: 10.1016/S0140-6736(05)66627-5.
Prinssen M, Verhoeven EL, Buth J, Cuypers PW, van Sambeek MR, Balm R, Buskens E, Grobbee DE, Blankensteijn JD; Dutch Randomized Endovascular Aneurysm Management (DREAM)Trial Group. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004 Oct 14;351(16):1607-18. doi: 10.1056/NEJMoa042002.
Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004 Sep 4-10;364(9437):843-8. doi: 10.1016/S0140-6736(04)16979-1.
Brunkwall J, Hauksson H, Bengtsson H, Bergqvist D, Takolander R, Bergentz SE. Solitary aneurysms of the iliac arterial system: an estimate of their frequency of occurrence. J Vasc Surg. 1989 Oct;10(4):381-4. doi: 10.1067/mva.1989.13733.
Richardson JW, Greenfield LJ. Natural history and management of iliac aneurysms. J Vasc Surg. 1988 Aug;8(2):165-71.
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.
Hobo R, Sybrandy JE, Harris PL, Buth J; EUROSTAR Collaborators. Endovascular repair of abdominal aortic aneurysms with concomitant common iliac artery aneurysm: outcome analysis of the EUROSTAR Experience. J Endovasc Ther. 2008 Feb;15(1):12-22. doi: 10.1583/07-2217.1.
Timaran CH, Lipsitz EC, Veith FJ, Chuter T, Greenberg RK, Ohki T, Nolte LA, Snyder SA; Zenith Investigators. Endovascular aortic aneurysm repair with the Zenith endograft in patients with ectatic iliac arteries. Ann Vasc Surg. 2005 Mar;19(2):161-6. doi: 10.1007/s10016-004-0157-8.
Ziegler P, Avgerinos ED, Umscheid T, Perdikides T, Erz K, Stelter WJ. Branched iliac bifurcation: 6 years experience with endovascular preservation of internal iliac artery flow. J Vasc Surg. 2007 Aug;46(2):204-10. doi: 10.1016/j.jvs.2007.04.015. Epub 2007 Jun 27.
Abraham CZ, Reilly LM, Schneider DB, Dwyer S, Sawhney R, Messina LM, Chuter TA. A modular multi-branched system for endovascular repair of bilateral common iliac artery aneurysms. J Endovasc Ther. 2003 Apr;10(2):203-7. doi: 10.1177/152660280301000207.
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.
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.
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.
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.
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.
Bratby MJ, Munneke GM, Belli AM, Loosemore TM, Loftus I, Thompson MM, Morgan RA. How safe is bilateral internal iliac artery embolization prior to EVAR? Cardiovasc Intervent Radiol. 2008 Mar-Apr;31(2):246-53. doi: 10.1007/s00270-007-9203-6. Epub 2007 Oct 24.
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.
Torsello G, Schonefeld E, Osada N, Austermann M, Pennekamp C, Donas KP. Endovascular treatment of common iliac artery aneurysms using the bell-bottom technique: long-term results. J Endovasc Ther. 2010 Aug;17(4):504-9. doi: 10.1583/10-3112.1.
Karthikesalingam A, Hinchliffe RJ, Holt PJ, Boyle JR, Loftus IM, Thompson MM. Endovascular aneurysm repair with preservation of the internal iliac artery using the iliac branch graft device. Eur J Vasc Endovasc Surg. 2010 Mar;39(3):285-94. doi: 10.1016/j.ejvs.2009.11.018. Epub 2009 Dec 3.
Parlani G, Verzini F, De Rango P, Brambilla D, Coscarella C, Ferrer C, Cao P. Long-term results of iliac aneurysm repair with iliac branched endograft: a 5-year experience on 100 consecutive cases. Eur J Vasc Endovasc Surg. 2012 Mar;43(3):287-92. doi: 10.1016/j.ejvs.2011.12.011. Epub 2012 Jan 10.
Verzini F, Parlani G, Romano L, De Rango P, Panuccio G, Cao P. Endovascular treatment of iliac aneurysm: Concurrent comparison of side branch endograft versus hypogastric exclusion. J Vasc Surg. 2009 May;49(5):1154-61. doi: 10.1016/j.jvs.2008.11.100.
Verhoeven EL, Oikonomou K, Mohner B, Renner H, Ritter W; European C3 Global Registry Participants. First experience with the new repositionable C3 excluder stent-graft. J Cardiovasc Surg (Torino). 2011 Oct;52(5):637-42. Epub 2011 Jul 29.
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.
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.

Public notes

Contacts

Principal investigator

Name

Michel Reijnen

Address

Rijnstate Hospital

Country

Phone

Fax

Email

Contact person for public queries

Name

Address

Country

Phone

Fax

Email

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.

Results not provided in https://clinicaltrials.gov/study/NCT02345005