Evaluation of a Novel Method of Contrast Volume Quantification - The AVERT PLUS
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Anand Prasad
- 入组人数
- 10
- 主要终点
- Observational study of the accuracy of this system to quantify contrast volume during a clinical indicated procedure
研究概览
简要总结
Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures.
Research Design: The AVERT PLUS is an FDA 510K cleared device which consists of a contrast delivery modulator designed to reduce unnecessary contrast dye delivery to the patient during angiography (coronary or peripheral) and a concomitant system to precisely measure contrast volume delivered to the patient. This will be a first in man prospective observational study of the accuracy of this system to quantify contract volume used during clinically indicated angiography in the cardiac catheterization laboratory.
详细描述
Thirty consecutive subjects who consent to participate and are undergoing planned angiography will be enrolled. The AVERT PLUS is a system which is external to the patient and connected to the control syringe that the physician uses to deliver the contrast dye to the patient. For each injection that the physician performs, the starting syringe volume, the ending syringe volume, and the net contrast delivered to the patient will be recorded. At the same time, the net volume delivered to the patient will also be recorded from the AVERT PLUS console. For each injection, these two sets of variables will be compared to determine accuracy of the AVERT PLUS to quantify net contrast volume used.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •subjects aged 18 or older with cardiovascular disease scheduled to undergo clinically indicated coronary or peripheral angiography who give informed consent to participate.
排除标准
- 未提供
结局指标
主要结局
Observational study of the accuracy of this system to quantify contrast volume during a clinical indicated procedure
时间窗: During procedure
次要结局
未报告次要终点
研究者
Anand Prasad
Assistant Professor of Medicine
The University of Texas Health Science Center at San Antonio
