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Iliac Branch Excluder ReGistry (IceBERG) (IceBERG)

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ClinicalTrials.gov Identifier: NCT02345005
Recruitment Status : Active, not recruiting
First Posted : January 26, 2015
Last Update Posted : September 3, 2018
Sponsor:
Collaborator:
W.L.Gore & Associates
Information provided by (Responsible Party):
Michel Reijnen, Rijnstate Hospital

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.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysms Common Iliac Aneurysms Aneurysm Device: The Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis.

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Multi-centre, Observational, Post-market, Real World Registry to Assess Outcomes of Patients Treated With the Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis
Study Start Date : November 2014
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Immediate technical success [ Time Frame: Procedure ]
    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.

  2. Peri-operative and post-operative safety parameters [ Time Frame: Up to 30 days postprocedure ]

    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

  3. Primary patency of hypogastric side branch [ Time Frame: At 1 year postprocedure ]
    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.


Secondary Outcome Measures :
  1. Anatomical success [ Time Frame: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years ]
    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.

  2. Technical endpoints [ Time Frame: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years ]

    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

  3. Clinical success [ Time Frame: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years ]
    Defined as freedom from flow-limiting stenosis and freedom from new onset of clinical ischemic symptoms (buttock claudication, erectile dysfunction, bowel ischaemia).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients in whom a Gore IBE was or will be implanted.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345005


Locations
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Italy
Fondazione Poliambulanza
Brescia, Italy
Cardarelli Hospital
Naples, Italy
San Filippo Neri Hospital
Rome, Italy
Netherlands
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA
Elisabeth Hospital
Tilburg, Netherlands
New Zealand
Auckland Hospital
Auckland, New Zealand
Spain
Complexo Hospitelario Universitario de Ourense (CHUO)
Ourense, Spain
Hospital Casa de Salud
Valencia, Spain
Sponsors and Collaborators
Rijnstate Hospital
W.L.Gore & Associates
Investigators
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Principal Investigator: Michel Reijnen Rijnstate Hospital
Study Director: Steven van Sterkenburg Rijnstate Hospital

Additional Information:

Publications:

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Responsible Party: Michel Reijnen, Vascular surgeon, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT02345005     History of Changes
Other Study ID Numbers: 1060-011014
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018

Keywords provided by Michel Reijnen, Rijnstate Hospital:
Vascular diseases
Aneurysm
Treatment Efficacy
Medical device
Population Register

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases