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

Semmelweis University Heart and Vascular Center30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Air volume

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

Time frame: within 7 days after index procedure