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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)"
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platinum-fibered Microcoils (FPC) | Other | Embolization using platinum fibred Coils (Cook Incorporated, Bloomington, IN, USA) |
|
| MVP® Vascular Plug | Other | Embolization using MVP®-Plug (Medtronic Inc., Minneapolis, MI, USA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular embolization | Procedure | Endovascular embolization of the Lumbar Arteries |
|
| 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 |
| 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 |
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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 understands the duration of the study, agrees to attend the stentgraft implantation
A microcatheter is successfully placed the target lumbar artery.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dierk Scheinert, Prof. Dr. | University Clinic Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic Leipzig | Leipzig | Saxony | 04103 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38700601 | Derived | Konert M, Schmidt A, Branzan D, Wittig T, Scheinert D, Steiner S. ELECT: prospective, randomized trial comparing microvascular plug versus platinum-fibered microcoils for embolization of aneurysm sac side branches before endovascular aortic aneurysm repair. CVIR Endovasc. 2024 May 3;7(1):42. doi: 10.1186/s42155-024-00454-6. |
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| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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