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
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.
Fondazione Poliambulanza
Brescia, Italy
Cardarelli Hospital
Naples, Italy
San Filippo Neri Hospital
Rome, Italy
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
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
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
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Elisabeth Hospital
Tilburg, Netherlands
Auckland Hospital
Auckland, New Zealand
Complexo Hospitelario Universitario de Ourense (CHUO)
Ourense, Spain
Hospital Casa de Salud
Valencia, Spain
Bowel ischemia measured following adverse events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured yearly up to 5 years