Abdominal Aortic Aneurysms, Aneurysm, Common Iliac Aneurysms
Conditions
Keywords
Vascular diseases, Aneurysm, Treatment Efficacy, Medical device, Population Register
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.
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.
Interventions
DEVICEThe 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.
Sponsors
W.L.Gore & Associates
Rijnstate Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and feasibility of the IBE device | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Failure of the IBE device | Measured at 1 month, 6 months, 1 year and then yearly up to 5 years | Freedom from type I and type III endoleak |
| Primary-assisted patency of the hypogastric branch | Measured at 1 month, 6 months, 1 year and then yearly up to 5 years | Primary-assisted patency of the hypogastric branch measured with duplex ultrasound or CT during follow-up |
| Secondary patency of the hypogastric branch | Measured at 1 month, 6 months, 1 year and then yearly up to 5 years | Secondary patency of the hypogastric branch measured with duplex ultrasound or CT |
| Erectile dysfunction | Measured at 1 month, 6 months, 1 year and then yearly up to 5 years | Erectile dysfunction measured during regular follow-up and with the IIEF-5 questionnaire |
| Freedom from aneurysm rupture | Measured at 1 month, 6 months, 1 year and then yearly up to 5 years | Aneurysm rupture will be measured following adverse events and reinterventions |
| Mortality | Measured at 1 month, 6 months, 1 year and then yearly up to 5 years | Mortality measured during regular follow-up and adverse events |
| Patency | Measured yearly up to 5 years | Patency of the hypogastric branch measured with duplex ultrasound or CT |
| Buttock claudication | Measured at 1 month, 6 months, 1 year and then yearly up to 5 years | Buttock claudication measured during regular follow-up |
| Bowel ischemia | Measured at 1 month, 6 months, 1 year and then yearly up to 5 years | Bowel ischemia measured following adverse events |
Countries
Italy, Netherlands, New Zealand, Spain
Outcome results
None listed