NCT04721951已完成不适用
CO2-EVAR - An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair - (Proof of Concept Study)
University of Bologna1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2018年12月12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
- 65
- 试验地点
- 1
- 主要终点
- Technical Success
研究概览
简要总结
The study aims to perform Endovascular Aortic Repair procedures with CO2-Angiography using a standardized an operative Protocol
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age > 18 years
- •Male, female
- •Patients with indication for AAA
- •Informed consent achievement
排除标准
- •Severe COPD (Chronic Obstructive Pulmonary Disease)
- •Known atrium- or ventricular septal defect with right-left-shunt
- •Severe renal arteries atherosclerosis
- •Ruptured AAA
- •Current partecipation in other interventional studies
结局指标
主要结局
Technical Success
时间窗: 30 Days
Technical success to assess the renal ostia and the hypogastric arteries (defined as 100% accuracy correlated to the iodinated contrast agent angiography or IVUS/FUSION techniques)
次要结局
- Adverse Events(30 Days)
- Image Quality(30 Days)
- Endoleak Detection(30 Days)
- CO2 Quantity(30 Days)
- Aneurysm Exclusion(30 Days)
研究者
Andrea Vacirca
MD
University of Bologna
研究点 (1)
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