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NCT04909190 Clinical Trial

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

Stroke Clinical Trial

— SAFRANE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04909190
Other study ID # SF2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 10, 2021
Est. completion date June 30, 2022

Study information
Verified date July 2022
Source Semmelweis University Heart and Vascular Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - endovascular aortic repair of an abdominal aortic aneurysm using either of these devices: Terumo/Bolton Treo, Terumo Anaconda, Cook Zenith Alpha Abdominal Exclusion Criteria: - concomitant use of an iliac bifurcation device due to insufficient common iliac landing zone on either side

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Increased saline flush volume
Additional flushing of the stentgraft delivery system.

Locations
Country Name City State
Hungary Heart and Vascular Center Budapest

Sponsors (1)
Lead Sponsor Collaborator
Semmelweis University Heart and Vascular Center

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary Air volume Total volume of air inside the aneurysm sac on discharge CT imaging. within 7 days after index procedure
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