Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan

Carotid Stenosis Clinical Trial

— CSS  

Official title:

Noninvasive Evaluation for Carotid Artery Stenosis: The Carotid Stenotic Scan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04057183
• Other study ID #: CVRMed
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2019
• Source: CVR Medical
• Contact: Phillip J Bendick, PhD
• Phone: 2483960314
• Email: pbeninnc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Stenosis
• Constriction, Pathologic

Intervention

Diagnostic Test:
• Carotid Stenotic Scan
Noninvasive determination of presence or absence of carotid artery stenosis

Locations

Country	Name	City	State
United States	Michigan Vascular Center	Flint	Michigan
United States	Wake Forest Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Phillip J Bendick

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of CSS result to carotid artery duplex ultrasound examination	Percent agreement and negative predictive value of CSS compared to duplex ultrasound	CSS and duplex ultrasound done within one week of each other