Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS 2.0
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Anand Prasad
- 入组人数
- 20
- 主要终点
- Observational study of the accuracy of the AVERT PLUS CM system to quantify contrast volume during a clinically 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. This will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.
详细描述
Research Design:
The AVERT PLUS is an FDA 510K cleared device which consists of 1) a contrast delivery modulator designed to reduce unnecessary contract dye delivery to the patient during angiography (coronary or peripheral) and 2) a concomitant contrast monitoring 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 contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.
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
- •Patients undergoing clinically indicated coronary or peripheral angiography
排除标准
- 未提供
结局指标
主要结局
Observational study of the accuracy of the AVERT PLUS CM system to quantify contrast volume during a clinically indicated procedure.
时间窗: The total volume of contrast received by the subject will be measured at the conclusion of the angiography procedure, procedure duration from 30 minutes to 4 hours dependent on patient's clinical status; no further measurements thereafter.
The fluid volume of contrast media used during the angiography procedure will be measured in milliliters.
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