NCT04909190已完成不适用
A Randomized Trial of an Increased Saline Flush Protocol to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System
Semmelweis University Heart and Vascular Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Air volume
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •endovascular aortic repair of an abdominal aortic aneurysm using either of these devices: Terumo/Bolton Treo, Terumo Anaconda, Cook Zenith Alpha Abdominal
排除标准
- •concomitant use of an iliac bifurcation device due to insufficient common iliac landing zone on either side
结局指标
主要结局
Air volume
时间窗: within 7 days after index procedure
Total volume of air inside the aneurysm sac on discharge CT imaging.
次要结局
未报告次要终点
研究者
Csaba Csobay-Novák MD PhD
Chief radiologist, Noninvasive Imaging
Semmelweis University Heart and Vascular Center
研究点 (2)
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