ELECT Trial - Embolization of the Lumbar Arteries Before EVAR

Study Overview
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Brief Summary
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Prospective, Randomized, Single-center Study for the Treatment of Subjects with Abdominal Aortic Aneurysm: Embolization of the Lumbar Arteries Before EVAR: A Prospectively Randomized Trial Comparing Platinum-Fibered Microcoils (control arm) with the MVP® Microvascular Plug (study arm)

Detailed Description
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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.

Official Title
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Embolization of the Lumbar Arteries Before EVAR: A Prospectively Randomized Trial Comparing Platinum-Fibered Microcoils (Control Arm) With the MVP® Microvascular Plug (Study Arm)

Conditions
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Aortic Aneurysm

Intervention / Treatment
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* Procedure: Endovascular embolization


Participation Criteria
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Eligibility Criteria
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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)

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Platinum-fibered Microcoils (FPC)<br>Embolization using platinum fibred Coils (Cook Incorporated, Bloomington, IN, USA) | Procedure: Endovascular embolization<br>* Endovascular embolization of the Lumbar Arteries<br>|
| Other: MVP® Vascular Plug<br>Embolization using MVP®-Plug (Medtronic Inc., Minneapolis, MI, USA). | Procedure: Endovascular embolization<br>* Endovascular embolization of the Lumbar Arteries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dose for embolization of the lumbar arteries with the MVP plug or coils |  | through study completion, an average of 3-4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention time for embolization of the lumbar arteries with the MVP plug or coils |  | through study completion, an average of 3-4 month | 
| Success in complete occlusion of the targeted lumbar artery |  | through study completion, an average of 3-4 month |