Clinical trial NCT03041168: Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
Official title: Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carotid Artery Disease
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: CVR Global, Inc.
First posted: 2017-02-02
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference between percent carotid artery stenosis measured by CSS and by carotid ultrasound
timeFrame: CSS reported percentage of carotid stenosis within 30 days of carotid ultrasound
Secondary outcomes:
measure: Difference between percent carotid artery stenosis measured by CSS and by carotid CTA
timeFrame: CSS reported percentage of carotid stenosis within 30 days of carotid CTA
measure: Difference between percent carotid artery stenosis measured by CSS and by carotid MRA
timeFrame: CSS reported percentage of carotid stenosis within 30 days of carotid MRA
measure: Difference between percent carotid artery stenosis measured by CSS and carotid angiogram
timeFrame: CSS reported percentage of carotid stenosis within 30 days of carotid angiogram
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: David J Whellan, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: