Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

Carotid Artery Disease Clinical Trial

Official title:

Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03041168
• Other study ID #: 16G.774
• Status: Terminated
• Start date: January 2017
• Est. completion date: March 15, 2018

Study information

• Verified date: November 2021
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 414
• Est. completion date: March 15, 2018
• Est. primary completion date: March 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases

Intervention

Device:
• Carotid Stenotic Scan
Each subject will have been scheduled for a carotid ultrasound, or other imaging test of the neck (carotids) as ordered by his/her physician for clinical or screening purposes. These studies will be read by a Jefferson radiologist and a report generated for standard clinical purposes. These reports and the images will be collected and de-identified to be used as comparator measurements to the CSS results. The CSS device is shaped like a stethoscope with 3 small gel pads. It is positioned with a gel pad on either side of the neck and one on the front of the chest. The scan takes about 1-2 minutes to provide an image on the screen of the device cart. The scan device pads just lie on the skin and do not use any invasive techniques to provide the image.

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	CVR Global, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Difference between percent carotid artery stenosis measured by CSS and carotid angiogram		CSS reported percentage of carotid stenosis within 30 days of carotid angiogram