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

A Randomized Trial of an Increased Saline Flush Protocol 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.

Study Overview

• Status: Completed
• Conditions: Stroke; Aortic Aneurysm; Aortic Diseases; Aortic Aneurysm, Thoracic; Aortic Arch Aneurysm
• Intervention / Treatment: Procedure: Increased saline flush volume

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1122
    • Heart and Vascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1xIFU; Subjects in this arm are randomized to have a saline flush volume according to the IFU of the used device.
Experimental: 4xIFU; 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.	Procedure: Increased saline flush volume; Additional flushing of the stentgraft delivery system.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Semmelweis University Heart and Vascular Center
• Investigators: Study Director: Csaba Csobay-Novák, MD PhD, Dept. of Interventional Radiology, Heart and Vascular Center, Semmelweis University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: endovascular; stentgraft; evar; tevar; de-airing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aortic Diseases
• Other Study ID Numbers: SF2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No