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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2022-06-30

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1xIFU

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Increased saline flush volume

Intervention Type PROCEDURE

Additional flushing of the stentgraft delivery system.

Interventions

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Increased saline flush volume

Additional flushing of the stentgraft delivery system.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* endovascular aortic repair of an abdominal aortic aneurysm using either of these devices: Terumo/Bolton Treo, Terumo Anaconda, Cook Zenith Alpha Abdominal