Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis

NeuroTherapia, Inc.

Status: Terminated

Conditions: Carotid Artery Stenosis

Treatments: Diagnostic Test: Carotid Stenotic Scan (CSS)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03464851

IRB 18-126

Details and patient eligibility

About

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.

Full 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).

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

51 participants in 3 patient groups

Unknown/Normal/Mild Disease

Description:

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

Treatment:

Diagnostic Test: Carotid Stenotic Scan (CSS)

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

Treatment:

Diagnostic Test: Carotid Stenotic Scan (CSS)

Known ICA Fibromuscular Dysplasia

Treatment:

Diagnostic Test: Carotid Stenotic Scan (CSS)