NCT04909190

Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System

A Randomized Trial of an Increased Saline Flush Protocol to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Semmelweis University Heart and Vascular Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Diseases
• Aortic Arch Aneurysm
• Stroke

Interventions

Type	Name	Description
PROCEDURE	Increased saline flush volume	Additional flushing of the stentgraft delivery system.

Timeline

• Start date: 2021-06-10
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-06-01
• Last updated: 2022-07-20

Locations

1 site across 1 country: Hungary