Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis
Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis
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 ultrasound study.
Currently, carotid duplex ultrasound is used for screening 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. 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 Global. The CSS instrument uses principles of cardiovascular resonance to detect low
 frequency pressure fluctuations associated with flow disturbances in areas of significant
 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 before or after the carotid
 duplex ultrasound.

 Within 3 months following the date of the initial study visit, the electronic medical record
 will be queried for any interval correlative imaging studies (CTA, MRA, or angiography) and
 reports performed up to 1 month prior and 3 months after the duplex examination date. Report
 of findings will be documented (i.e., % ICA stenosis by CTA/MRA).
Inclusion Criteria:

 -  Outpatients age > 18 years sent to the vascular laboratory for carotid duplex
 examination for initial carotid ultrasound study or for follow-up of known carotid
 disease.

 -  Enrolled patients will include at least 100 subjects with at least moderate known
 stenosis (50-69% or greater, PSV > 125 cm/sec) or occlusion of one or both ICAs

 -  Up to 25 patients with known fibromuscular dysplasia (FMD) of the internal carotid
 arteries.

 Exclusion Criteria:

 -  Age < 18 years.

 -  Hospitalized inpatients.

 -  Inability to provide informed consent.

 -  Prior history of carotid endarterectomy or carotid artery stent.

 -  Prior neck surgery

 -  Known prosthetic heart valve, known critical aortic stenosis, or study indication
 "preop" open heart or aortic surgery.