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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02345005
Ethics application status
Date submitted
19/01/2015
Date registered
26/01/2015
Date last updated
11/09/2019

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
Immediate technical success - Primary endpoint of the retrospective part of the registry. Defined as successful implantation of the IBE device without the presence of endoleak type I or III and without flow-limiting dissection or stenosis.
Timepoint [1] 0 0
Procedure
Primary outcome [2] 0 0
Peri-operative and post-operative safety parameters - Primary endpoint of the retrospective part of the registry. Described as:
Mortality (all-cause; aneurysm-related, device-related)
Bowel Ischemia
Myocardial Infarction
Paraplegia
Renal Failure
Respiratory Failure
Stroke
Procedural Blood Loss =1,000mL
Timepoint [2] 0 0
Up to 30 days postprocedure
Primary outcome [3] 0 0
Primary patency of hypogastric side branch - Primary endpoint of the prospective part of the registry. Defined as an open prothesis without flow-limiting stenosis (PSV<2.5), successful exclusion of the aneurysm without type I or II endoleak.
Timepoint [3] 0 0
At 1 year postprocedure
Secondary outcome [1] 0 0
Anatomical success - Secondary outcome of both parts of the registry. Defined as exclusion of the aneurysm without endoleak type I and III, and open stentgrafts on imaging without significant stenosis.
Timepoint [1] 0 0
Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary outcome [2] 0 0
Technical endpoints - Secondary outcome of both parts of the registry. Defined as:
Primary and primary-assisted patency of hypogastric side branch
Secondary patency of hypogastric artery
The presence of any endoleak
Freedom from aneurysm sac expansion and rupture
Device migration
Device occlusion
Conversion to open repair
Any secondary endovascular procedures, with special focus on Secondary endovascular procedures for resolution of: endoleak of any type, device occlusion (due to thrombus or other causes), device migration, abdominal aneurysm sac expansion, device defect
Timepoint [2] 0 0
Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary outcome [3] 0 0
Clinical success - Defined as freedom from flow-limiting stenosis and freedom from new onset of clinical ischemic symptoms (buttock claudication, erectile dysfunction, bowel ischaemia).
Timepoint [3] 0 0
Measured at 1 month, 6 months, 1 year and then 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
Gender
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
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/show/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.
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.
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.
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.
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.
Richardson JW, Greenfield LJ. Natural history and management of iliac aneurysms. J Vasc Surg. 1988 Aug;8(2):165-71. Review.
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.
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.
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. 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. Review.
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.
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.
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.
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.
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.
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. 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. Review.
Torsello G, Schönefeld 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. Review.
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, Möhner 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 Gonçalves F, Jairam A, Voûte 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 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

Summary results
Other publications