Aneurysm Clinical Trial
— IceBERGOfficial title:
Multi-centre, Observational, Post-market, Real World Registry to Assess Outcomes of Patients Treated With the Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis
Verified date | July 2023 |
Source | Rijnstate Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital | W.L.Gore & Associates |
Italy, Netherlands, New Zealand, Spain,
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
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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. — 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
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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
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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
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 |
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