An observational study in Carotid Artery Disease, sponsored by Thomas Jefferson University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-11.
Sponsored by Thomas Jefferson University · Observational
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.
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.
248 studies on the registry are indexed under Carotid Artery Diseases; 56 are open to participants now.
This study's enrollment of 414 is above the median of 224 across 108 observational studies indexed under Carotid Artery Diseases.
Browse Carotid Artery Diseases studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of patients presenting to a Jefferson facility for carotid imaging studies. Subjects scheduled for carotid artery assessments will be identified prior to the day of study using radiology scheduling.
Exclusion Criteria:
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.
Difference between percent carotid artery stenosis measured by CSS and by carotid ultrasound
Time frame: CSS reported percentage of carotid stenosis within 30 days of carotid ultrasound
Difference between percent carotid artery stenosis measured by CSS and by carotid CTA
Time frame: 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
Time frame: CSS reported percentage of carotid stenosis within 30 days of carotid MRA
Difference between percent carotid artery stenosis measured by CSS and carotid angiogram
Time frame: CSS reported percentage of carotid stenosis within 30 days of carotid angiogram
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Thomas Jefferson University