Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Thomas Jefferson University
- Enrollment
- 414
- Locations
- 1
- Primary Endpoint
- Difference between percent carotid artery stenosis measured by CSS and by carotid ultrasound
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)