Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

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.

Study Overview

• Status: Terminated
• Conditions: Carotid Artery Disease
• Intervention / Treatment: Device: Carotid Stenotic Scan

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 Type: Observational
• Enrollment (Actual): 414

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients presenting to a Jefferson facility for carotid imaging studies. Subjects scheduled for carotid artery assessments will be identified prior to the day of study using radiology scheduling.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 by carotid MRA	CSS reported percentage of carotid stenosis within 30 days of carotid MRA
Difference between percent carotid artery stenosis measured by CSS and carotid angiogram	CSS reported percentage of carotid stenosis within 30 days of carotid angiogram

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: CVR Global, Inc.
• Investigators: Principal Investigator: David J Whellan, MD MHS, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): March 15, 2018
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carotid Artery Diseases
• Other Study ID Numbers: 16G.774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes