Carotid Artery StenosisNCT03464851
Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis
An observational study of Carotid Artery Stenosis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the accuracy of a new non-invasive device, the Carotid Stenotic Scan (CSS), to check for stenosis of the internal carotid artery (ICA) as compared to a carotid ultrasound study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Carotid Stenotic Scan (CSS)
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2018to 1 Feb 2020
- 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 consistent of adult patients (> 18 years) presenting to the Cleveland Clinic Non-Invasive Vascular Laboratory for a scheduled carotid duplex ultrasound to evaluate for carotid artery disease or in follow-up of known ICA stenosis.
Who may be able to join
- Outpatients age > 18 years sent to the vascular laboratory for carotid duplex examination for initial carotid ultrasound study or for follow-up of known carotid disease.
- Enrolled patients will include at least 100 subjects with at least moderate known stenosis (50-69% or greater, PSV > 125 cm/sec) or occlusion of one or both ICAs
- Up to 25 patients with known fibromuscular dysplasia (FMD) of the internal carotid arteries.
Who cannot join
- Age < 18 years.
- Hospitalized inpatients.
- Inability to provide informed consent.
- Prior history of carotid endarterectomy or carotid artery stent.
- Prior neck surgery
- Known prosthetic heart valve, known critical aortic stenosis, or study indication "preop" open heart or aortic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the accuracy of a new non-invasive device, the Carotid Stenotic Scan (CSS), to check for stenosis of the internal carotid artery (ICA) as compared to a carotid ultrasound study.
Read the detailed description
Currently, carotid duplex ultrasound is used for screening for ICA stenosis and must be performed by a trained and certified vascular technologist using advanced duplex imaging equipment and with subsequent interpretation by a trained physician. It would be of value to develop an accurate, reliable, low-cost, and easily accessible tool to screen for extra-cranial ICA disease in an office based setting. However, such a tool would require novel technology that allows for quick, accurate, reproducible, and safe evaluation.
This study will evaluate a new technology called the Carotid Stenotic Scan (CSS) developed by CVR Global. The CSS instrument uses principles of cardiovascular resonance to detect low frequency pressure fluctuations associated with flow disturbances in areas of significant arterial narrowing.
Subjects will undergo a clinically ordered clinical carotid duplex ultrasound as part of standard of care. Subjects will have a noninvasive CSS assessment before or after the carotid duplex ultrasound.
Within 3 months following the date of the initial study visit, the electronic medical record will be queried for any interval correlative imaging studies (CTA, MRA, or angiography) and reports performed up to 1 month prior and 3 months after the duplex examination date. Report of findings will be documented (i.e., % ICA stenosis by CTA/MRA).
- Conditions
- Carotid Artery Stenosis
- Being tested
- Carotid Stenotic Scan (CSS)
- Keywords
- carotid artery stenosis, plaque, carotid duplex, ultrasound, fibromsucular dysplasia, carotid atherosclerosis
- Medical subject headings
- Carotid Stenosis, Plaque, Amyloid, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Stenotic Scan (CSS)Diagnostic test
Placement of the CSS instrument on the carotid arteries to measure degree of stenosis
of the carotid artery. The CSS scan takes about 1-2 minutes to gather data for real-time analysis by the processor on the device cart.
| Study group | Role | What they receive |
|---|---|---|
| Unknown/Normal/Mild Disease | No prior carotid duplex study or known normal or mild disease in the ICAs (PSV <= 125 cm/sec) Receives: Diagnostic Test: Carotid Stenotic Scan (CSS) | |
| Known moderate or severe ICA Stenosis (PSV>125 cm/sec) | Not described Receives: Diagnostic Test: Carotid Stenotic Scan (CSS) | |
| Known ICA Fibromuscular Dysplasia | Not described Receives: Diagnostic Test: Carotid Stenotic Scan (CSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of CSS readings to conventional carotid artery duplex ultrasound
Primary analysis % agreement CSS and carotid duplex ultrasound (SRUCC interpretation) for ICA stenosis
Measured: Baseline
Secondary outcomes (1)
Reproducibility of the CSS measurement
Each CSS measurement will be repeated and the Intraclass Correlation Coefficient (ICC) will be calculated. The ICC in an index of the reliability of measurements from the same operator
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start8 Mar 2018
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Why it stopped: Low enrollment due to inclusion/exclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- CVR Global, Inc.
- Responsible party
- Principal investigator, Imad Bagh, M. D., The Cleveland Clinic
- Investigators
- Imad Bagh, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464851
- Sponsor's protocol ID
- IRB 18-126
- Status last verified
- Apr 2020
- First submitted
- 8 Mar 2018
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Technique to Diagnose Carotid Artery Stenosis
- ClinicalTrials.gov ID
- NCT03464851
- Acronym / sponsor ID
- IRB 18-126
- Conditions
- Carotid Artery Stenosis
- Keywords
- carotid artery stenosis, plaque, carotid duplex, ultrasound, fibromsucular dysplasia, carotid atherosclerosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment due to inclusion/exclusion criteria
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- CVR Global, Inc.
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 14 Mar 2018 (actual)
- 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 purpose of this study is to determine the accuracy of a new non-invasive device, the Carotid Stenotic Scan (CSS), to check for stenosis of the internal carotid artery (ICA) as compared to a carotid ultrasound study.
Detailed description
Currently, carotid duplex ultrasound is used for screening for ICA stenosis and must be performed by a trained and certified vascular technologist using advanced duplex imaging equipment and with subsequent interpretation by a trained physician. It would be of value to develop an accurate, reliable, low-cost, and easily accessible tool to screen for extra-cranial ICA disease in an office based setting. However, such a tool would require novel technology that allows for quick, accurate, reproducible, and safe evaluation.
This study will evaluate a new technology called the Carotid Stenotic Scan (CSS) developed by CVR Global. The CSS instrument uses principles of cardiovascular resonance to detect low frequency pressure fluctuations associated with flow disturbances in areas of significant arterial narrowing.
Subjects will undergo a clinically ordered clinical carotid duplex ultrasound as part of standard of care. Subjects will have a noninvasive CSS assessment before or after the carotid duplex ultrasound.
Within 3 months following the date of the initial study visit, the electronic medical record will be queried for any interval correlative imaging studies (CTA, MRA, or angiography) and reports performed up to 1 month prior and 3 months after the duplex examination date. Report of findings will be documented (i.e., % ICA stenosis by CTA/MRA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unknown/Normal/Mild Disease | – | Diagnostic Test: Carotid Stenotic Scan (CSS)No prior carotid duplex study or known normal or mild disease in the ICAs (PSV <= 125 cm/sec) |
| Known moderate or severe ICA Stenosis (PSV>125 cm/sec) | – | Diagnostic Test: Carotid Stenotic Scan (CSS) |
| Known ICA Fibromuscular Dysplasia | – | Diagnostic Test: Carotid Stenotic Scan (CSS) |
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 consistent of adult patients (> 18 years) presenting to the Cleveland Clinic Non-Invasive Vascular Laboratory for a scheduled carotid duplex ultrasound to evaluate for carotid artery disease or in follow-up of known ICA stenosis.
Key inclusion criteria (3 listed)
- Outpatients age > 18 years sent to the vascular laboratory for carotid duplex examination for initial carotid ultrasound study or for follow-up of known carotid disease.
- Enrolled patients will include at least 100 subjects with at least moderate known stenosis (50-69% or greater, PSV > 125 cm/sec) or occlusion of one or both ICAs
- Up to 25 patients with known fibromuscular dysplasia (FMD) of the internal carotid arteries.
Key exclusion criteria (6 listed)
- Age < 18 years.
- Hospitalized inpatients.
- Inability to provide informed consent.
- Prior history of carotid endarterectomy or carotid artery stent.
- Prior neck surgery
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 Scan (CSS)Placement of the CSS instrument on the carotid arteries to measure degree of stenosis of the carotid artery. The CSS scan takes about 1-2 minutes to gather data for real-time analysis by the processor on the device cart. | Diagnostic test | Known ICA Fibromuscular Dysplasia, Known moderate or severe ICA Stenosis (PSV>125 cm/sec), Unknown/Normal/Mild Disease |
Primary outcome
Comparison of CSS readings to conventional carotid artery duplex ultrasound
Time frame: Baseline
Primary analysis % agreement CSS and carotid duplex ultrasound (SRUCC interpretation) for ICA stenosis
1 secondary outcome
Reproducibility of the CSS measurement
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Low enrollment due to inclusion/exclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- 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.
Imad Bagh, MD principal investigator
The Cleveland Clinic
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 Stenosis, run by The Cleveland Clinic 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 3 inclusion and 6 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 1 May 2020. 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: Low enrollment due to inclusion/exclusion criteria). 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?
Comparison of CSS readings to conventional carotid artery duplex ultrasound (time frame: Baseline). 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 1 May 2020.