Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan
Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan
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.
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.
Inclusion Criteria:

 -  Patients age ≥ 65 years scheduled for a diagnostic carotid artery duplex ultrasound
 study AND with one or more of the following:

 -  Hypertension

 -  Hyperlipidemia

 -  Diabetes

 -  Tobacco usage - Current or past

 -  Known CAD/PAD

 -  Family history of early onset of atherosclerotic disease

 Exclusion Criteria:

 -  Unable / unwilling to provide Informed Consent

 -  Prior carotid endarterectomy or carotid artery stent

 -  Aortic stenosis

 -  Congestive heart failure

 -  BMI > 35