Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

Conditions
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Carotid Artery Disease

Intervention / Treatment
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* Device: Carotid Stenotic Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects over 18 referred for carotid duplex ultrasound. Subjects over 18 referred for CT angiography, MR angiography, or conventional angiography of the carotid arteries Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Carotid Stenotic Scan|Each subject will have been scheduled for a carotid ultrasound, or other imaging test of the neck (carotids) as ordered by his/her physician for clinical or screening purposes. These studies will be read by a Jefferson radiologist and a report generated for standard clinical purposes. These reports and the images will be collected and de-identified to be used as comparator measurements to the CSS results. The CSS device is shaped like a stethoscope with 3 small gel pads. It is positioned with a gel pad on either side of the neck and one on the front of the chest. The scan takes about 1-2 minutes to provide an image on the screen of the device cart. The scan device pads just lie on the skin and do not use any invasive techniques to provide the image.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between percent carotid artery stenosis measured by CSS and by carotid ultrasound |  | CSS reported percentage of carotid stenosis within 30 days of carotid ultrasound | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 by carotid MRA |  | CSS reported percentage of carotid stenosis within 30 days of carotid MRA | 
| Difference between percent carotid artery stenosis measured by CSS and carotid angiogram |  | CSS reported percentage of carotid stenosis within 30 days of carotid angiogram |