Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

Terminated

• Conditions: Carotid Artery Disease

• Registration Number: NCT03041168
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-02
• Primary Completion: 2018-03-15
• Study Completion: 2018-03-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 414

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between percent carotid artery stenosis measured by CSS and by carotid ultrasound	CSS reported percentage of carotid stenosis within 30 days of carotid ultrasound

Secondary Outcome Measures

Name	Time	Method
Difference between percent carotid artery stenosis measured by CSS and by carotid CTA	CSS reported percentage of carotid stenosis within 30 days of carotid CTA
Difference between percent carotid artery stenosis measured by CSS and carotid angiogram	CSS reported percentage of carotid stenosis within 30 days of carotid angiogram
Difference between percent carotid artery stenosis measured by CSS and by carotid MRA	CSS reported percentage of carotid stenosis within 30 days of carotid MRA

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States