ELECT Trial - Embolization of the Lumbar Arteries Before EVAR

This study is a prospective, single-center, 1:1 randomized trial to investigate the difference in radiation dose and intervention time between the embolization with FCP and MVP-Plug.

Inclusion criteria

• Subject age ≥ 18
• Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
• Indication for the occlusion of lumbar arteries due to:

• Subject has an abdominal aortic aneurysm and
• At least 2 patent lumbar arteries in the diseased area
• Subject understands the duration of the study, agrees to attend the stentgraft implantation
• A microcatheter is successfully placed the target lumbar artery.

Exclusion criteria

• Any surgical procedure or intervention performed within 30 days prior to or post index procedure
• Aortic aneurysm requires treatment with alternative therapies such as operation
• any other aortic pathology
• major untreated cardio-pulmonary disease
• life-expectancy of less than one year
• expected lack of compliance (e.g. if the patient may not be willing to have several sessions and the following repair done)
• pregnant or nursing women
• impaired thyroid function, if not under stable treatment
• women of child-bearing potential without highly effective contraceptive measures
• Enrolled in another investigational drug, device or biologic study
• Failure to successfully intubate an lumbar artery
• Stroke or heart attack within 3 months prior to enrollment
• Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
• Platelet count <100,000 mm3 or >600,000 mm3
• Receiving dialysis or immunosuppressant therapy
• Chronic kidney disease (serum creatinine > 2.5 mg/dL)