An observational study in Carotid Stenosis, sponsored by Phillip J Bendick. Status unknown at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2019-08-16.
Sponsored by Phillip J Bendick · Observational
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.
349 studies on the registry are indexed under Carotid Stenosis; 82 are open to participants now.
This study's planned enrollment of 300 is above the median of 175 across 147 observational studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →This is the only study on the registry with Phillip J Bendick as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria identify an "at-risk" population with unknown carotid artery status. The literature indicates that patients who meet the criteria have a prevalence of significant carotid artery stenosis (>50%) of 7-10%. Current estimates are that 3 million adults in the United States have this degree of carotid artery disease with an annual stroke risk of 5-10%.
Exclusion criteria are in place to identify patients in whom the status of the carotid arteries is already likely known (prior CEA or stent), have significant heart disease which will impact flow hemodynamics and create false negative or positive studies (CHF, aortic stenosis), or have excessive subcutaneous neck tissue that will attenuate and mask the CSS signal (elevated BMI).
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Exclusion Criteria:
Noninvasive determination of presence or absence of carotid artery stenosis
Also known as: CSS
Comparison of CSS result to carotid artery duplex ultrasound examination
Percent agreement and negative predictive value of CSS compared to duplex ultrasound
Time frame: CSS and duplex ultrasound done within one week of each other
Plan to share: No — IPD will not be shared; only group data will be used.
No publications or documents are linked to this record.
Started Jul 2019 (actual). Primary completion is estimated for Dec 2019, 5 months after the start.
Of 82 observational studies under Carotid Stenosis, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 104. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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