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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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