Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis

Sponsor

The Cleveland Clinic (Other)

Overall Status

Terminated

CT.gov ID

NCT03464851

Collaborator

CVR Global, Inc. (Industry)

Enrollment

Location

22.8

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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 ultrasound study.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Stenosis	Diagnostic Test: Carotid Stenotic Scan (CSS)

Detailed 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).

Study Design

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis

Actual Study Start Date :

Mar 8, 2018

Actual Primary Completion Date :

Feb 1, 2020

Actual Study Completion Date :

Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Unknown/Normal/Mild Disease No prior carotid duplex study or known normal or mild disease in the ICAs (PSV <= 125 cm/sec)	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.
Known moderate or severe ICA Stenosis (PSV>125 cm/sec)	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.
Known ICA Fibromuscular Dysplasia	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.

Arm

Intervention/Treatment

Unknown/Normal/Mild Disease

No prior carotid duplex study or known normal or mild disease in the ICAs (PSV <= 125 cm/sec)

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.

Known moderate or severe ICA Stenosis (PSV>125 cm/sec)

Diagnostic Test: Carotid Stenotic Scan (CSS)

Known ICA Fibromuscular Dysplasia

Diagnostic Test: Carotid Stenotic Scan (CSS)

Outcome Measures

Primary Outcome Measures

Comparison of CSS readings to conventional carotid artery duplex ultrasound [Baseline]
Primary analysis % agreement CSS and carotid duplex ultrasound (SRUCC interpretation) for ICA stenosis

Secondary Outcome Measures

Reproducibility of the CSS measurement [Baseline]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.