Clinical trial NCT03842930: ELECT Trial - Embolization of the Lumbar Arteries Before EVAR
Official title: Embolization of the Lumbar Arteries Before EVAR: A Prospectively Randomized Trial Comparing Platinum-Fibered Microcoils (Control Arm) With the MVP® Microvascular Plug (Study Arm)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

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

Exclusion Criteria:

1. Any surgical procedure or intervention performed within 30 days prior to or post index procedure
2. Aortic aneurysm requires treatment with alternative therapies such as operation
3. any other aortic pathology
4. major untreated cardio-pulmonary disease
5. life-expectancy of less than one year
6. expected lack of compliance (e.g. if the patient may not be willing to have several sessions and the following repair done)
7. pregnant or nursing women
8. impaired thyroid function, if not under stable treatment
9. women of child-bearing potential without highly effective contraceptive measures
10. Enrolled in another investigational drug, device or biologic study
11. Failure to successfully intubate an lumbar artery
12. Stroke or heart attack within 3 months prior to enrollment
13. 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
14. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
15. Platelet count \<100,000 mm3 or \>600,000 mm3
16. Receiving dialysis or immunosuppressant therapy
17. Chronic kidney disease (serum creatinine \> 2.5 mg/dL)

Primary outcomes:
measure: Radiation dose for embolization of the lumbar arteries with the MVP plug or coils
timeFrame: through study completion, an average of 3-4 month
Secondary outcomes:
measure: Intervention time for embolization of the lumbar arteries with the MVP plug or coils
timeFrame: through study completion, an average of 3-4 month
measure: Success in complete occlusion of the targeted lumbar artery
timeFrame: through study completion, an average of 3-4 month
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Clinic Leipzig
state: Saxony
Study officials:
affiliation: University Clinic Leipzig
name: Dierk Scheinert, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: