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临床试验/NCT04057183
NCT04057183Unknown不适用

Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan

Phillip J Bendick2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
2
主要终点
Comparison of CSS result to carotid artery duplex ultrasound examination

研究概览

简要总结

The purpose of this study is to determine the accuracy of a new non-invasive device, the Carotid Stenotic Scan (CSS), to check for stenosis of the internal carotid artery (ICA) as compared to a carotid duplex ultrasound study.

详细描述

Currently, carotid duplex ultrasound is the primary diagnostic tool for the evaluation for ICA stenosis and must be performed by a trained and certified vascular technologist using advanced duplex imaging equipment and with subsequent interpretation by a trained physician. this test is not considered suitable for screening for disease. It would be of value to develop an accurate, reliable, low-cost, and easily accessible tool to screen for extra-cranial ICA disease in an office based setting. However, such a tool would require novel technology that allows for quick, accurate, reproducible, and safe evaluation.

This study will evaluate a new technology called the Carotid Stenotic Scan (CSS) developed by CVR Medical. The CSS instrument uses sensitive transducers to detect low frequency pressure fluctuations associated with flow disturbances downstream from areas of arterial narrowing.

Subjects will undergo a clinically ordered clinical carotid duplex ultrasound as part of standard of care. Subjects will have a noninvasive CSS assessment either before or after the carotid duplex ultrasound.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age ≥ 65 years scheduled for a diagnostic carotid artery duplex ultrasound study AND with one or more of the following:
  • Hypertension
  • Hyperlipidemia
  • Tobacco usage - Current or past
  • Known CAD/PAD
  • Family history of early onset of atherosclerotic disease

排除标准

  • Unable / unwilling to provide Informed Consent
  • Prior carotid endarterectomy or carotid artery stent
  • Aortic stenosis
  • Congestive heart failure
  • BMI > 35

结局指标

主要结局

Comparison of CSS result to carotid artery duplex ultrasound examination

时间窗: CSS and duplex ultrasound done within one week of each other

Percent agreement and negative predictive value of CSS compared to duplex ultrasound

次要结局

未报告次要终点

研究者

发起方
Phillip J Bendick
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Phillip J Bendick

Study Coordinator

CVR Medical

研究点 (2)

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