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

Semmelweis University

Status: Completed

Conditions: Stroke; Aortic Aneurysm, Thoracic; Aortic Arch Aneurysm; Aortic Aneurysm; Aortic Diseases

Treatments: Procedure: Increased saline flush volume

Study type: Interventional

Funder types: Other

Identifiers

NCT04909190

SF2021

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

1xIFU

No Intervention group

Description:

Subjects in this arm are randomized to have a saline flush volume according to the IFU of the used device.

4xIFU

Experimental group

Description:

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.

Treatment:

Procedure: Increased saline flush volume