Abdominal Aortic AneurysmsIceBERGNCT02345005
Iliac Branch Excluder ReGistry (IceBERG)
An observational study of Abdominal Aortic Aneurysms and Common Iliac Aneurysms, run by Rijnstate Hospital at 8 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms, Common Iliac Aneurysms, Aneurysm
- What is being tested?
- The Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis.
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Nov 2014to Jul 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients in whom a Gore IBE was or will be implanted.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Italy3 sites
Fondazione Poliambulanza
Brescia
Cardarelli Hospital
Naples
San Filippo Neri Hospital
Rome
Netherlands2 sites
Rijnstate Hospital
Arnhem, Gelderland, 6800 TA
Elisabeth Hospital
Tilburg
Spain2 sites
Complexo Hospitelario Universitario de Ourense (CHUO)
Ourense
Hospital Casa de Salud
Valencia
About this study
Official title: Multi-centre, Observational, Post-market, Real World Registry to Assess Outcomes of Patients Treated With the Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis
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.
Read the detailed 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.
- Conditions
- Abdominal Aortic Aneurysms, Common Iliac Aneurysms, Aneurysm
- Being tested
- The Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis.
- Keywords
- Vascular diseases, Aneurysm, Treatment Efficacy, Medical device, Population Register
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Up to 1 year postprocedure
Secondary outcomes (9)
Primary-assisted patency of the hypogastric branch
Primary-assisted patency of the hypogastric branch measured with duplex ultrasound or CT during follow-up
Measured: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary patency of the hypogastric branch
Secondary patency of the hypogastric branch measured with duplex ultrasound or CT
Measured: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Buttock claudication
Buttock claudication measured during regular follow-up
Measured: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Erectile dysfunction
Erectile dysfunction measured during regular follow-up and with the IIEF-5 questionnaire
Measured: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Bowel ischemia
Bowel ischemia measured following adverse events
Measured: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Failure of the IBE device
Freedom from type I and type III endoleak
Measured: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Freedom from aneurysm rupture
Aneurysm rupture will be measured following adverse events and reinterventions
Measured: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Mortality
Mortality measured during regular follow-up and adverse events
Measured: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Patency
Patency of the hypogastric branch measured with duplex ultrasound or CT
Measured: Measured yearly up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2025
- Study completionJul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- W.L.Gore & Associates
- Responsible party
- Principal investigator, Michel Reijnen, Rijnstate Hospital
- Investigators
- Michel Reijnen, Principal investigator, Rijnstate HospitalSteven van Sterkenburg, Study director, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345005
- Sponsor's protocol ID
- 1060-011014
- Acronym
- IceBERG
- Status last verified
- Dec 2025
- First submitted
- 19 Jan 2015
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15944424EVAR 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.
PubMed 15978925Prinssen 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.
PubMed 15483279Greenhalgh 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.
PubMed 15351191Brunkwall 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.
PubMed 2795762Richardson JW, Greenfield LJ. Natural history and management of iliac aneurysms. J Vasc Surg. 1988 Aug;8(2):165-71.
PubMed 3294450Armon 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.
PubMed 9587341Hobo 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.
PubMed 18254666Timaran 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.
PubMed 15776309Ziegler 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.
PubMed 17600664Abraham 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.
PubMed 12877600Su 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.
PubMed 14981467Razavi 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.
PubMed 10834485Karch 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.
PubMed 11013030Yano 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.
PubMed 11496269
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Observational, Post-market, Real World Registry to Assess Outcomes of Patients Treated With the Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis
- ClinicalTrials.gov ID
- NCT02345005
- Acronym / sponsor ID
- IceBERG / 1060-011014
- Conditions
- Abdominal Aortic Aneurysms, Common Iliac Aneurysms, Aneurysm
- Keywords
- Vascular diseases, Aneurysm, Treatment Efficacy, Medical device, Population Register
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- W.L.Gore & Associates
- Study start
- Nov 2014 (actual)
- Primary completion
- Jul 2025 (actual)
- Study completion
- Jul 2025 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in whom a Gore IBE was or will be implanted.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Safety and feasibility of the IBE device
Time frame: Procedure and up to 30 days post procedure
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
Primary patency of the hypogastric side branch
Time frame: Up to 1 year postprocedure
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.
9 secondary outcomes
Primary-assisted patency of the hypogastric branch
Time frame: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Secondary patency of the hypogastric branch
Time frame: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Buttock claudication
Time frame: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Erectile dysfunction
Time frame: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Bowel ischemia
Time frame: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Failure of the IBE device
Time frame: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Freedom from aneurysm rupture
Time frame: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Mortality
Time frame: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years
Patency
Time frame: Measured yearly up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Background: PubMed 15944424Blankensteijn 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.
- Background: PubMed 15978925EVAR 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.
- Background: PubMed 15483279Prinssen 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.
- Background: PubMed 15351191Greenhalgh 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.
- Background: PubMed 2795762Brunkwall 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.
- Background: PubMed 3294450Richardson JW, Greenfield LJ. Natural history and management of iliac aneurysms. J Vasc Surg. 1988 Aug;8(2):165-71.
- Background: PubMed 9587341Armon 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.
- Background: PubMed 18254666Hobo 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.
- Background: PubMed 15776309Timaran 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.
- Background: PubMed 17600664Ziegler 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.
- Background: PubMed 12877600Abraham 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.
- Background: PubMed 14981467Su 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Reijnen principal investigator
Rijnstate Hospital
Steven van Sterkenburg study director
Rijnstate Hospital
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysms and Common Iliac Aneurysms, run by Rijnstate Hospital at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Netherlands, Spain, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and feasibility of the IBE device (time frame: Procedure and up to 30 days post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02345005, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.