Carotid Artery DiseaseNCT03041168
Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
An observational study of Carotid Artery Disease, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Disease
- What is being tested?
- Carotid Stenotic Scan
- Type of treatment
- Medical device
- How many people
- 414 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 15 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subjects over 18 referred for carotid duplex ultrasound.
- Subjects over 18 referred for CT angiography, MR angiography, or conventional angiography of the carotid arteries
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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.
Read the 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.
- Conditions
- Carotid Artery Disease
- Being tested
- Carotid Stenotic Scan
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Stenotic ScanDevice
Each subject will have been scheduled for a carotid ultrasound, or other imaging test of the neck (carotids) as ordered by his/her physician for clinical or screening purposes. These studies will be read by a Jefferson radiologist and a report generated for standard clinical purposes. These reports and the images will be collected and de-identified to be used as comparator measurements to the CSS results. The CSS device is shaped like a stethoscope with 3 small gel pads. It is positioned with a gel pad on either side of the neck and one on the front of the chest. The scan takes about 1-2 minutes to provide an image on the screen of the device cart. The scan device pads just lie on the skin and do not use any invasive techniques to provide the image.
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between percent carotid artery stenosis measured by CSS and by carotid ultrasound
Measured: CSS reported percentage of carotid stenosis within 30 days of carotid ultrasound
Secondary outcomes (3)
Difference between percent carotid artery stenosis measured by CSS and by carotid CTA
Measured: 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
Measured: CSS reported percentage of carotid stenosis within 30 days of carotid MRA
Difference between percent carotid artery stenosis measured by CSS and carotid angiogram
Measured: CSS reported percentage of carotid stenosis within 30 days of carotid angiogram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startJan 2017
- Primary completion15 Mar 2018
- Study completion15 Mar 2018
Why it stopped: Study was stopped due to suspension of funding from CVR Global.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- CVR Global, Inc.
- Responsible party
- Sponsor
- Investigators
- David J Whellan, MD MHS, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041168
- Sponsor's protocol ID
- 16G.774
- Status last verified
- Nov 2021
- First submitted
- 11 Jan 2017
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Technique to Investigate CAS Piezo Electric Sensors
- ClinicalTrials.gov ID
- NCT03041168
- Acronym / sponsor ID
- 16G.774
- Conditions
- Carotid Artery Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was stopped due to suspension of funding from CVR Global.
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- CVR Global, Inc.
- Study start
- Jan 2017
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Subjects over 18 referred for carotid duplex ultrasound.
- Subjects over 18 referred for CT angiography, MR angiography, or conventional angiography of the carotid arteries
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid Stenotic ScanEach subject will have been scheduled for a carotid ultrasound, or other imaging test of the neck (carotids) as ordered by his/her physician for clinical or screening purposes. These studies will be read by a Jefferson radiologist and a report generated for standard clinical purposes. These reports and the images will be collected and de-identified to be used as comparator measurements to the CSS results. The CSS device is shaped like a stethoscope with 3 small gel pads. It is positioned with a gel pad on either side of the neck and one on the front of the chest. The scan takes about 1-2 minutes to provide an image on the screen of the device cart. The scan device pads just lie on the skin and do not use any invasive techniques to provide the image. | Device | – |
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
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Study was stopped due to suspension of funding from CVR Global.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Whellan, MD MHS principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Disease, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was stopped due to suspension of funding from CVR Global.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.