Iliac Branch Excluder ReGistry (IceBERG)

Rijnstate Hospital100 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Abdominal Aortic Aneurysms Common Iliac Aneurysms Aneurysm

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Fondazione Poliambulanza

Brescia, Italy

Cardarelli Hospital

Naples, Italy

San Filippo Neri Hospital

Rome, Italy

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: Up to 1 year postprocedure

Secondary Outcomes

Primary-assisted patency of the hypogastric branch

Primary-assisted patency of the hypogastric branch measured with duplex ultrasound or CT during follow-up

Time frame: 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

Time frame: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years

Buttock claudication

Buttock claudication measured during regular follow-up

Time frame: 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

Time frame: Measured at 1 month, 6 months, 1 year and then yearly up to 5 years

Bowel ischemia

Data from ClinicalTrials.gov

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