NCT04057183

Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Phillip J Bendick · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Carotid Stenosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Carotid Stenotic Scan	Noninvasive determination of presence or absence of carotid artery stenosis

Timeline

• Start date: 2019-07-01
• Primary completion: 2019-12-31
• Completion: 2020-06-30
• First posted: 2019-08-15
• Last updated: 2019-08-16

Locations

2 sites across 1 country: United States