Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan

• Conditions: Carotid Stenosis

• Registration Number: NCT04057183
• Lead Sponsor: Phillip J Bendick

Brief 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.

Study Timeline

• Study Start: 2019-07-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-13
• Last Update Submitted: 2019-08-14
• Study First Posted: 2019-08-15
• Last Update Posted: 2019-08-16
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients age ≥ 65 years scheduled for a diagnostic carotid artery duplex ultrasound study AND with one or more of the following:
• Hypertension
• Hyperlipidemia
• Diabetes
• Tobacco usage - Current or past
• Known CAD/PAD
• Family history of early onset of atherosclerotic disease

Exclusion Criteria

• Unable / unwilling to provide Informed Consent
• Prior carotid endarterectomy or carotid artery stent
• Aortic stenosis
• Congestive heart failure
• BMI > 35

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of CSS result to carotid artery duplex ultrasound examination	CSS and duplex ultrasound done within one week of each other	Percent agreement and negative predictive value of CSS compared to duplex ultrasound

Trial Locations

Locations (2)

Wake Forest Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Michigan Vascular Center; 🇺🇸 Flint, Michigan, United States