Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Difference between percent carotid artery stenosis measured by CSS and by carotid ultrasound
研究概览
简要总结
The proposed study is evaluating a novel technology, Carotid Stenotic Scan (CSS), developed by the sponsor, CVR Global. Study Design. This is a prospective cohort study that will compare a new application of a technology, the CSS device, to reference standards for assessment of carotid disease.
详细描述
The overall objectives of this study are to demonstrate that the Carotid Stenotic Scan (CSS) can accurately detect significant carotid artery stenosis.
Secondary objective is to relate changes in CSS signal to different degrees of stenosis. We obtain a "proof of concept" if the device correlates strongly with the established classification of atherosclerotic carotid disease derived various imaging modalities including magnetic resonance angiography (MRA) and computer tomographic angiography (CTA), conventional angiography, or carotid 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects over 18 referred for carotid duplex ultrasound.
- •Subjects over 18 referred for CT angiography, MR angiography, or conventional angiography of the carotid arteries
排除标准
- •Previous history of carotid endarterectomy, carotid artery stent
- •Previous surgery involving the neck (including thyroidectomy or parathyroidectomy)
- •Patients with prosthetic heart valve
- •Patients unable to provide informed consent.
结局指标
主要结局
Difference between percent carotid artery stenosis measured by CSS and by carotid ultrasound
时间窗: CSS reported percentage of carotid stenosis within 30 days of carotid ultrasound
次要结局
- Difference between percent carotid artery stenosis measured by CSS and by carotid CTA(CSS reported percentage of carotid stenosis within 30 days of carotid CTA)
- Difference between percent carotid artery stenosis measured by CSS and carotid angiogram(CSS reported percentage of carotid stenosis within 30 days of carotid angiogram)
- Difference between percent carotid artery stenosis measured by CSS and by carotid MRA(CSS reported percentage of carotid stenosis within 30 days of carotid MRA)