Status:
COMPLETED
ELECT Trial - Embolization of the Lumbar Arteries Before EVAR
Lead Sponsor:
University of Leipzig
Conditions:
Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
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 P...
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
- 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
- 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)
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03842930
Start Date
March 1 2019
End Date
December 1 2021
Last Update
May 18 2022
Active Locations (1)
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1
University Clinic Leipzig
Leipzig, Saxony, Germany, 04103