Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

Thomas Jefferson University

Status: Terminated

Conditions: Carotid Artery Disease

Treatments: Device: Carotid Stenotic Scan

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03041168

16G.774

Details and patient eligibility

About

The proposed study is evaluating a novel technology, Carotid Stenotic Scan (CSS), developed by the sponsor, CVR Global. Study Design. This is a prospective cohort study that will compare a new application of a technology, the CSS device, to reference standards for assessment of carotid disease.

Full description

The overall objectives of this study are to demonstrate that the Carotid Stenotic Scan (CSS) can accurately detect significant carotid artery stenosis.

Secondary objective is to relate changes in CSS signal to different degrees of stenosis. We obtain a "proof of concept" if the device correlates strongly with the established classification of atherosclerotic carotid disease derived various imaging modalities including magnetic resonance angiography (MRA) and computer tomographic angiography (CTA), conventional angiography, or carotid ultrasound.

Enrollment: 414 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects over 18 referred for carotid duplex ultrasound.
• Subjects over 18 referred for CT angiography, MR angiography, or conventional angiography of the carotid arteries

Exclusion criteria

• Previous history of carotid endarterectomy, carotid artery stent
• Previous surgery involving the neck (including thyroidectomy or parathyroidectomy)
• Patients with prosthetic heart valve
• Patients unable to provide informed consent.