Carotid Artery StenosisCAS-PRONCT05270005
Progression Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound Flow Imaging
An observational study of Carotid Artery Stenosis, run by Rijnstate Hospital at 2 sites in Netherlands.
Trial summary
Rationale: Approximately 15-20% of strokes originates from an atherosclerotic plaque rupture in the carotid artery. To reduce the risk of stroke, patients should be evaluated for possible carotid endarterectomy (CEA), which is based on simple geometrical and clinical measures. 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?
- Ultrasound-based flow imaging, Ultrasound-based strain imaging and Conventional duplex
- How many people
- 85 participants
- Where
- 2 sitesNetherlands
- Study dates
- 7 Apr 2022to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with an asymptomatic carotid artery stenosis, defined by 30% to 69% narrowing of the carotid artery according to conventional duplex measurements in the absence of ipsilateral retinal or cerebral ischemia in the preceding 6 months.
Who may be able to join
- Adult male or female (≥18 years old);
- Informed consent form understood and signed, and patient agrees to follow-up visits;
- Presence of carotid artery stenosis (between 30%-69%) according to conventional duplex measurements (peak-systolic velocity of 125-230 cm/s [5] in combination with visible lumen reduction >30% according to North American Symptomatic Carotid Endarterectomy Trial [NASCET] method);
- Defined asymptomatic with respect to the ipsilateral carotid artery stenosis.
Who cannot join
- A planned carotid revascularisation for the ipsilateral carotid artery stenosis at date of inclusion;
- History of carotid revascularisation at artery under investigation;
- Visible near occlusion at asymptomatic stenosis side according to conventional duplex measurements;
- Life expectancy < 2 years;
- Participating in another clinical study, interfering on outcomes
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Rijnstate Hospital
Arnhem
Radboud university medical center
Nijmegen
About this study
Rationale: Approximately 15-20% of strokes originates from an atherosclerotic plaque rupture in the carotid artery. To reduce the risk of stroke, patients should be evaluated for possible carotid endarterectomy (CEA), which is based on simple geometrical and clinical measures. Multiple studies have shown that the current risk stratification may lead to both over- and under-treatment for patients with carotid artery stenosis. This implicates that the current guidelines are lacking patient-specific parameters and have limited sensitivity. There is a wealth of evidence implicating the important role of local (disturbed) blood flow throughout the onset and progression of atherosclerosis. Novel flow-related measures, that go beyond simple geometrical indications, are required to improve diagnosis and treatment in patients with carotid artery stenosis. Nowadays, ultrasound (US) is one of the main techniques to assess for the presence and extent of carotid artery stenosis. However, current clinically-used US systems are unable to acquire and visualize the complex flow phenomena that play such a crucial role in the atherosclerotic disease process. With the advent of ultrafast ultrasound imaging, acquiring thousands of images per second, continuous tracking of flow in all directions became feasible, which enables us to image two-dimensional blood flow and possible disturbances with high accuracy and precision.
In this project, we aim to assess whether flow (related) parameters are associated with disease progression (and if so, which), in order to map the progression of atherosclerotic plaques using non-invasive, US-based blood flow imaging. In the future, this could improve risk stratification for individual patients for surgery, decrease patient mortality and morbidity, and therefore reduce healthcare costs.
Read more
Objective: To longitudinally assess the association between spatio-temporal blood flow velocities (peak systole and end-diastole at common carotid artery, maximum stenosis and internal carotid artery) and the progression of carotid atherosclerosis defined by duplex measurements.
Secondary objectives are to investigate the association between blood flow-derived parameters, including wall shear stress (WSS), vector complexity and vorticity, and the progression of atherosclerosis defined by duplex measurements. Furthermore, to assess the association between spatio-temporal blood flow velocities and blood flow-derived parameters (WSS, vector complexity and vorticity) and the progression of atherosclerosis as measured using ultrasound-based strain imaging.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Ultrasound-based flow imaging, Ultrasound-based strain imaging, Conventional duplex
- Keywords
- Ultrafast ultrasound flow imaging, Atherosclerotic plaque, Disease progression, Velocity vector imaging
- Medical subject headings
- Carotid Stenosis, Plaque, Atherosclerotic, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-based flow imagingDiagnostic test
Ultrasound-based flow imaging of the carotid artery stenosis will be acquired at baseline and two annual follow-up appointments.
Ultrasound-based strain imagingDiagnostic test
Ultrasound-based strain imaging of the carotid artery stenosis will be acquired at baseline and two annual follow-up appointments.
Conventional duplexDiagnostic test
Conventional duplex measurements of the carotid artery stenosis will be acquired at baseline and two annual follow-up appointments.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic carotid artery stenosis | Patients with an asymptomatic carotid artery stenosis, defined by 30% to 69% narrowing of the carotid artery according to conventional duplex measurements in the absence of ipsilateral retinal or cerebral ischemia in the preceding 6 months. Receives: Diagnostic Test: Ultrasound-based flow imaging; Diagnostic Test: Ultrasound-based strain imaging; Diagnostic Test: Conventional duplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-dimensional spatio-temporal blood flow velocities
Two-dimensional vector velocity fields derived from the US-based flow imaging will be used to calculate the spatio-temporal blood flow velocities.
Measured: 2 year follow-up
Plaque progression (stenosis degree)
Plaque progression, defined by increase in stenosis degree. Stenosis degree will be quantified by conventional ultrasound imaging.
Measured: 2 year follow-up
Secondary outcomes (5)
Wall shear stress
Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is the wall shear stress.
Measured: 2 year follow-up
Vorticity
Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is vorticity.
Measured: 2 year follow-up
Vector complexity
Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is vector complexity.
Measured: 2 year follow-up
Plaque progression (deformation)
Plaque progression, defined by change in plaque deformation. Plaque deformation will be quantified by strain imaging.
Measured: 2 year follow-up
Symptomatic carotid stenosis
Measured: 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start7 Apr 2022
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- 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
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270005
- Sponsor's protocol ID
- 2021-1915
- Acronym
- CAS-PRO
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2022
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ruisch J, Holewijn S, Vermeer SE, Reijnen MMPJ, de Korte CL, Saris AECM. Blood Flow Characteristics in Patients with Asymptomatic Carotid Artery Stenosis Using Ultrasound-based Velocity Vector Imaging. Ultrasound Med Biol. 2026 Oct;52(10):2204-2212. doi: 10.1016/j.ultrasmedbio.2026.06.009. Epub 2026 Jul 25.
PubMed 42498657
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound Flow Imaging
- ClinicalTrials.gov ID
- NCT05270005
- Acronym / sponsor ID
- CAS-PRO / 2021-1915
- Conditions
- Carotid Artery Stenosis
- Keywords
- Ultrafast ultrasound flow imaging, Atherosclerotic plaque, Disease progression, Velocity vector imaging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Mar 2022 (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.
Rationale: Approximately 15-20% of strokes originates from an atherosclerotic plaque rupture in the carotid artery. To reduce the risk of stroke, patients should be evaluated for possible carotid endarterectomy (CEA), which is based on simple geometrical and clinical measures. Multiple studies have shown that the current risk stratification may lead to both over- and under-treatment for patients with carotid artery stenosis. This implicates that the current guidelines are lacking patient-specific parameters and have limited sensitivity. There is a wealth of evidence implicating the important role of local (disturbed) blood flow throughout the onset and progression of atherosclerosis. Novel flow-related measures, that go beyond simple geometrical indications, are required to improve diagnosis and treatment in patients with carotid artery stenosis. Nowadays, ultrasound (US) is one of the main techniques to assess for the presence and extent of carotid artery stenosis. However, current clinically-used US systems are unable to acquire and visualize the complex flow phenomena that play such a crucial role in the atherosclerotic disease process. With the advent of ultrafast ultrasound imaging, acquiring thousands of images per second, continuous tracking of flow in all directions became feasible, which enables us to image two-dimensional blood flow and possible disturbances with high accuracy and precision.
In this project, we aim to assess whether flow (related) parameters are associated with disease progression (and if so, which), in order to map the progression of atherosclerotic plaques using non-invasive, US-based blood flow imaging. In the future, this could improve risk stratification for individual patients for surgery, decrease patient mortality and morbidity, and therefore reduce healthcare costs.
Objective: To longitudinally assess the association between spatio-temporal blood flow velocities (peak systole and end-diastole at common carotid artery, maximum stenosis and internal carotid artery) and the progression of carotid atherosclerosis defined by duplex measurements.
Secondary objectives are to investigate the association between blood flow-derived parameters, including wall shear stress (WSS), vector complexity and vorticity, and the progression of atherosclerosis defined by duplex measurements. Furthermore, to assess the association between spatio-temporal blood flow velocities and blood flow-derived parameters (WSS, vector complexity and vorticity) and the progression of atherosclerosis as measured using ultrasound-based strain imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic carotid artery stenosis | – | Diagnostic Test: Ultrasound-based flow imaging, Diagnostic Test: Ultrasound-based strain imaging, Diagnostic Test: Conventional duplexPatients with an asymptomatic carotid artery stenosis, defined by 30% to 69% narrowing of the carotid artery according to conventional duplex measurements in the absence of ipsilateral retinal or cerebral ischemia in the preceding 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an asymptomatic carotid artery stenosis, defined by 30% to 69% narrowing of the carotid artery according to conventional duplex measurements in the absence of ipsilateral retinal or cerebral ischemia in the preceding 6 months.
Key inclusion criteria (4 listed)
- Adult male or female (≥18 years old);
- Informed consent form understood and signed, and patient agrees to follow-up visits;
- Presence of carotid artery stenosis (between 30%-69%) according to conventional duplex measurements (peak-systolic velocity of 125-230 cm/s [5] in combination with visible lumen reduction >30% according to North American Symptomatic Carotid Endarterectomy Trial [NASCET] method);
- Defined asymptomatic with respect to the ipsilateral carotid artery stenosis.
Key exclusion criteria (5 listed)
- A planned carotid revascularisation for the ipsilateral carotid artery stenosis at date of inclusion;
- History of carotid revascularisation at artery under investigation;
- Visible near occlusion at asymptomatic stenosis side according to conventional duplex measurements;
- Life expectancy < 2 years;
- Participating in another clinical study, interfering on outcomes
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 |
|---|---|---|
| Ultrasound-based flow imagingUltrasound-based flow imaging of the carotid artery stenosis will be acquired at baseline and two annual follow-up appointments. | Diagnostic test | Asymptomatic carotid artery stenosis |
| Ultrasound-based strain imagingUltrasound-based strain imaging of the carotid artery stenosis will be acquired at baseline and two annual follow-up appointments. | Diagnostic test | Asymptomatic carotid artery stenosis |
| Conventional duplexConventional duplex measurements of the carotid artery stenosis will be acquired at baseline and two annual follow-up appointments. | Diagnostic test | Asymptomatic carotid artery stenosis |
Primary outcome
Two-dimensional spatio-temporal blood flow velocities
Time frame: 2 year follow-up
Two-dimensional vector velocity fields derived from the US-based flow imaging will be used to calculate the spatio-temporal blood flow velocities.
Plaque progression (stenosis degree)
Time frame: 2 year follow-up
Plaque progression, defined by increase in stenosis degree. Stenosis degree will be quantified by conventional ultrasound imaging.
5 secondary outcomes
Wall shear stress
Time frame: 2 year follow-up
Vorticity
Time frame: 2 year follow-up
Vector complexity
Time frame: 2 year follow-up
Plaque progression (deformation)
Time frame: 2 year follow-up
Symptomatic carotid stenosis
Time frame: 2 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 42498657Ruisch J, Holewijn S, Vermeer SE, Reijnen MMPJ, de Korte CL, Saris AECM. Blood Flow Characteristics in Patients with Asymptomatic Carotid Artery Stenosis Using Ultrasound-based Velocity Vector Imaging. Ultrasound Med Biol. 2026 Oct;52(10):2204-2212. doi: 10.1016/j.ultrasmedbio.2026.06.009. Epub 2026 Jul 25.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Rijnstate Hospital at 2 sites in Netherlands.
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Two-dimensional spatio-temporal blood flow velocities (time frame: 2 year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05270005, which also lists 1 linked publication.
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 12 Feb 2025.