Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis

Carotid Artery Stenosis Clinical Trial

Official title:

Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03464851
• Other study ID #: IRB 18-126
• Status: Terminated
• Start date: March 8, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: April 2020
• Source: The Cleveland Clinic
• Contact: n/a
• 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 ultrasound study.

Description:

Currently, carotid duplex ultrasound is used for screening 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. 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 Global. The CSS instrument uses principles of cardiovascular resonance to detect low frequency pressure fluctuations associated with flow disturbances in areas of significant 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 before or after the carotid duplex ultrasound.

Within 3 months following the date of the initial study visit, the electronic medical record will be queried for any interval correlative imaging studies (CTA, MRA, or angiography) and reports performed up to 1 month prior and 3 months after the duplex examination date. Report of findings will be documented (i.e., % ICA stenosis by CTA/MRA).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Outpatients age > 18 years sent to the vascular laboratory for carotid duplex examination for initial carotid ultrasound study or for follow-up of known carotid disease.

• Enrolled patients will include at least 100 subjects with at least moderate known stenosis (50-69% or greater, PSV > 125 cm/sec) or occlusion of one or both ICAs

• Up to 25 patients with known fibromuscular dysplasia (FMD) of the internal carotid arteries.

Exclusion Criteria:

• Age < 18 years.

• Hospitalized inpatients.

• Inability to provide informed consent.

• Prior history of carotid endarterectomy or carotid artery stent.

• Prior neck surgery

• Known prosthetic heart valve, known critical aortic stenosis, or study indication "preop" open heart or aortic surgery.

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic

Intervention

Diagnostic Test:
• Carotid Stenotic Scan (CSS)
Placement of the CSS instrument on the carotid arteries to measure degree of stenosis of the carotid artery. The CSS scan takes about 1-2 minutes to gather data for real-time analysis by the processor on the device cart.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	CVR Global, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of CSS readings to conventional carotid artery duplex ultrasound	Primary analysis % agreement CSS and carotid duplex ultrasound (SRUCC interpretation) for ICA stenosis	Baseline
Secondary	Reproducibility of the CSS measurement	Each CSS measurement will be repeated and the Intraclass Correlation Coefficient (ICC) will be calculated. The ICC in an index of the reliability of measurements from the same operator	Baseline