Aortic Aneurysm
Conditions
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.
Interventions
PROCEDUREEndovascular embolization
Endovascular embolization of the Lumbar Arteries
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Germany
Outcome results
None listed