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

Not Applicable

Completed

• Conditions: Stroke; Aortic Aneurysm; Aortic Arch Aneurysm; Aortic Aneurysm, Thoracic; Aortic Diseases
• Interventions: Procedure: Increased saline flush volume

• Registration Number: NCT04909190
• Lead Sponsor: Semmelweis University Heart and Vascular Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-06-01
• Study Start: 2021-06-10
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4xIFU	Increased saline flush volume	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.

Primary Outcome Measures

Name	Time	Method
Air volume	within 7 days after index procedure	Total volume of air inside the aneurysm sac on discharge CT imaging.

Trial Locations

Locations (1)

Heart and Vascular Center; 🇭🇺 Budapest, Hungary