Iliac Branch Excluder ReGistry (IceBERG)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abdominal Aortic Aneurysms, Common Iliac Aneurysms, Aneurysm

Intervention / Treatment
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* Device: The Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| Buttock claudication | Buttock claudication measured during regular follow-up | 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 at 1 month, 6 months, 1 year and then yearly up to 5 years | 
| Bowel ischemia | Bowel ischemia measured following adverse events | 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 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 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 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 yearly up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular diseases, Aneurysm, Treatment Efficacy, Medical device, Population Register