跳至主要内容
临床试验/NCT02434055
NCT02434055终止不适用

Evaluation of a Novel Method of Contrast Volume Quantification - The AVERT PLUS

Anand Prasad0 个研究点目标入组 10 人开始时间: 2015年4月最近更新:
适应症

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

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

发起方
Anand Prasad
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anand Prasad

Assistant Professor of Medicine

The University of Texas Health Science Center at San Antonio

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