Iliac Branch Excluder ReGistry (IceBERG)

Aneurysm Clinical Trial

— IceBERG  

Official title:

Multi-centre, Observational, Post-market, Real World Registry to Assess Outcomes of Patients Treated With the Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02345005
• Other study ID #: 1060-011014
• Status: Active, not recruiting
• Start date: November 2014
• Est. completion date: July 2025

Study information

• Verified date: July 2023
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Rationale: 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. The later has a proven safety and efficacy in excluding abdominal aortic aneurysms. The Gore IBE device got CE mark on October 2013. Technical and clinical data at short and long terms are still to be collected to give insight into technical success rates, patency data and long term follow-up.

Objective and design: This investigator-initiated 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.

Study population: All patients in whom a Gore IBE was or will be implanted. In the retrospective part of the study all implantations in the Netherlands will be gathered, whereas the prospective part will be expanded in Europe.

Main study parameters/endpoints: Aneurysm exclusion and reinterventions will be end-points of this study. As safety and feasibility is the main outcome of the retrospective part, the data will be analyzed at 30-days. Patients in the prospective study will be followed for 5 years, with the primary end-point being hypogastric side branch patency at 1-year. Clinical endpoints include freedom from symptoms of pelvic ischemia (buttock claudication, impotence and bowel ischemia) and freedom from aneurysm rupture.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is a registry study, no burden or risk exist for the patient. There is also no direct benefit for the participating patients, but the gathered data will improve insight for patients with the same disease and might improve health care in the future for this group of patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Common Iliac Aneurysms
• Iliac Aneurysm

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Italy	Fondazione Poliambulanza	Brescia
Italy	Cardarelli Hospital	Naples
Italy	San Filippo Neri Hospital	Rome
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Elisabeth Hospital	Tilburg
New Zealand	Auckland Hospital	Auckland
Spain	Complexo Hospitelario Universitario de Ourense (CHUO)	Ourense
Spain	Hospital Casa de Salud	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	W.L.Gore & Associates

Countries where clinical trial is conducted

Italy,  Netherlands,  New Zealand,  Spain, 

References & Publications (25)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Richardson JW, Greenfield LJ. Natural history and management of iliac aneurysms. J Vasc Surg. 1988 Aug;8(2):165-71. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Primary-assisted patency of the hypogastric branch	Primary-assisted patency of the hypogastric branch measured with duplex ultrasound or CT during follow-up	Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary	Secondary patency of the hypogastric branch	Secondary patency of the hypogastric branch measured with duplex ultrasound or CT	Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary	Buttock claudication	Buttock claudication measured during regular follow-up	Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary	Erectile dysfunction	Erectile dysfunction measured during regular follow-up and with the IIEF-5 questionnaire	Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary	Bowel ischemia	Bowel ischemia measured following adverse events	Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary	Failure of the IBE device	Freedom from type I and type III endoleak	Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary	Freedom from aneurysm rupture	Aneurysm rupture will be measured following adverse events and reinterventions	Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary	Mortality	Mortality measured during regular follow-up and adverse events	Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary	Patency	Patency of the hypogastric branch measured with duplex ultrasound or CT	Measured yearly up to 5 years