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

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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Key information

Conditions

Aortic Aneurysm Aneurysm Aneurysm, Aortic Arch Aortic Aneurysm, Thoracic Aortic Arch Aneurysm Aortic Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart and Vascular Center

Budapest, 1122, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Increased saline flush volume

Procedure

Additional flushing of the stentgraft delivery system.

Primary outcomes

Air volume

Time frame: within 7 days after index procedure

Total volume of air inside the aneurysm sac on discharge CT imaging.

Sponsors and collaborators

Lead sponsor

Semmelweis University Heart and Vascular Center

Other

Registry information

Official study title

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

Acronym: SAFRANE

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 1, 2021
Registry last updated: Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed