Clinical Trial: Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors

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 Summary:

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.


Sponsor: Thomas Jefferson University

Current Primary Outcome: Difference between percent carotid artery stenosis measured by CSS and by carotid ultrasound [ Time Frame: CSS reported percentage of carotid stenosis within 30 days of carotid ultrasound ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Difference between percent carotid artery stenosis measured by CSS and by carotid CTA [ Time Frame: 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 [ Time Frame: CSS reported percentage of carotid stenosis within 30 days of carotid MRA ]
  • Difference between percent carotid artery stenosis measured by CSS and carotid angiogram [ Time Frame: CSS reported percentage of carotid stenosis within 30 days of carotid angiogram ]


Original Secondary Outcome: Same as current

Information By: Thomas Jefferson University

Dates:
Date Received: January 11, 2017
Date Started: January 2017
Date Completion: June 2019
Last Updated: February 1, 2017
Last Verified: February 2017