Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan (CSS)
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|ClinicalTrials.gov Identifier: NCT04057183|
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : August 16, 2019
|Condition or disease||Intervention/treatment|
|Carotid Stenosis||Diagnostic Test: Carotid Stenotic Scan|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 30, 2020|
- Diagnostic Test: Carotid Stenotic Scan
Noninvasive determination of presence or absence of carotid artery stenosisOther Name: CSS
- Comparison of CSS result to carotid artery duplex ultrasound examination [ Time Frame: CSS and duplex ultrasound done within one week of each other ]Percent agreement and negative predictive value of CSS compared to duplex ultrasound
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057183
|Contact: Phillip J Bendick, PhDfirstname.lastname@example.org|
|Contact: Tony Robinsonemail@example.com|
|United States, Michigan|
|Michigan Vascular Center||Not yet recruiting|
|Flint, Michigan, United States, 48507|
|Contact: Mark Mattos, MD 810-732-1620 firstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest Medical Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Aarti Sarwal, MD 336-716-3961 email@example.com|