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Non-randomized studies have shown that de-airing of the delivery system with an increased volume of saline may be associated to a decrease in periprocedural stroke during thoracic endovascular aortic repair. This study is designed to provide evidence that 4xIFU-dose volume of saline flush vs. standard IFU-dose saline flush is associated to a decrease in the amount of intra-sac air detected on the first follow-up imaging after EVAR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1xIFU | No Intervention | Subjects in this arm are randomized to have a saline flush volume according to the IFU of the used device. | |
| 4xIFU | Experimental | Subjects in this arm are randomized to have a saline flush volume of 4x of what is stated in the IFU of the used device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Increased saline flush volume | Procedure | Additional flushing of the stentgraft delivery system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Air volume | Total volume of air inside the aneurysm sac on discharge CT imaging. | within 7 days after index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Csaba Csobay-Novák, MD PhD | Dept. of Interventional Radiology, Heart and Vascular Center, Semmelweis University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart and Vascular Center | Budapest | 1122 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38586170 | Derived | Szentivanyi A, Borzsak S, Vecsey-Nagy M, Suvegh A, Huttl A, Fontanini DM, Szeberin Z, Csobay-Novak C. The impact of increasing saline flush volume to reduce the amount of residual air in the delivery system of aortic prostheses-a randomized controlled trial. Front Cardiovasc Med. 2024 Mar 22;11:1335903. doi: 10.3389/fcvm.2024.1335903. eCollection 2024. |
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| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D017545 | Aortic Aneurysm, Thoracic |
| D001018 | Aortic Diseases |
| D000094626 | Aneurysm, Aortic Arch |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |