Carotid Artery Disease Clinical Trial
Official title:
Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
NCT number | NCT03041168 |
Other study ID # | 16G.774 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | March 15, 2018 |
Verified date | November 2021 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University | CVR Global, Inc. |
United States,
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 |
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