Carotid Artery StenosisCAS-iFLOWNCT06170580
Improved Image Quality for Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound FLOW Imaging
An observational study of Carotid Artery Stenosis, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Objective: To evaluate the technical performance of a novel cascaded wave imaging technique compared to plane wave imaging for blood flow imaging in patients with and without carotid artery stenosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Conventional duplex, Ultrasound-based flow imaging using plane wave imaging and Ultrasound-based flow imaging using cascaded wave imaging
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Nov 2023to 10 Mar 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 patients with and 10 patients without a hemodynamic significant carotid artery stenosis
Who may be able to join
- Capacitated adult male or female (≥18 years old);
- Informed consent form understood and signed;
- Recent conventional duplex measurement of the carotid artery confirming either the absence or presence of a plaque
Who cannot join
- Hampered carotid blood flow imaging during conventional duplex/doppler measurements due to near to total carotid occlusion at the side of interest or a calcified plaque;
- History of radiation at the head-neck area;
- Participating in another clinical study, interfering on outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To evaluate the technical performance of a novel cascaded wave imaging technique compared to plane wave imaging for blood flow imaging in patients with and without carotid artery stenosis.
Study design: Observational, feasibility study in a total of 10 patients with and 10 patients without a hemodynamic significant carotid artery plaque.
Intervention (observational): all participants will undergo a carotid ultrasound measurement including conventional duplex ultrasound and ultrasound based flow imaging using plane waves and cascaded waves.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Conventional duplex, Ultrasound-based flow imaging using plane wave imaging, Ultrasound-based flow imaging using cascaded wave imaging
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional duplexDiagnostic test
Conventional carotid duplex measurement
Ultrasound-based flow imaging using plane wave imagingDiagnostic test
Ultrasound-based flow imaging using plane wave imaging
Ultrasound-based flow imaging using cascaded wave imagingDiagnostic test
Ultrasound-based flow imaging using cascaded wave imaging
| Study group | Role | What they receive |
|---|---|---|
| Participants with a hemodynamic significant carotid artery stenosis | Not described Receives: Diagnostic Test: Conventional duplex; Diagnostic Test: Ultrasound-based flow imaging using plane wave imaging; Diagnostic Test: Ultrasound-based flow imaging using cascaded wave imaging | |
| Participants without a hemodynamic significant carotid artery stenosis | Not described Receives: Diagnostic Test: Conventional duplex; Diagnostic Test: Ultrasound-based flow imaging using plane wave imaging; Diagnostic Test: Ultrasound-based flow imaging using cascaded wave imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
2D velocity vector fields obtained by plane wave and cascaded wave imaging of the carotid artery
Measured: After study completion, average of one year
Secondary outcomes (5)
Signal-to-noise ratio obtained from plane wave and cascaded wave imaging will be obtained and compared for different vessel depths
Measured: After study completion, average of one year
Cross-correlation maps of plane wave and cascaded wave imaging will be obtained and compared for different vessel depths
Measured: After study completion, average of one year
Velocity vector fields obtained from plane wave and cascaded wave imaging will be obtained and compared
Measured: After study completion, average of one year
Blood-flow related parameters, including vector complexity and vorticity, will be calculated from 2D velocity fields.
Measured: After study completion, average of one year
Spatiotemporal blood flow profiles obtained with plane wave, cascaded wave and conventional duplex ultrasound will be compared to assess the correlation between these techniques
Measured: After study completion, average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start16 Nov 2023
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
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.
- More trials run by Radboud University Medical CenterThe 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
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170580
- Sponsor's protocol ID
- 114554
- Acronym
- CAS-iFLOW
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2023
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Bakker JMK, Ruisch J, de Korte CL, Saris AECM. Cascaded Plane Wave Ultrasound Velocity Vector Imaging: In Vivo Feasibility in Carotid Arteries. IEEE Trans Ultrason Ferroelectr Freq Control. 2025 Dec;72(12):1607-1617. doi: 10.1109/TUFFC.2025.3631658.
PubMed 41217908
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Image Quality for Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound FLOW Imaging
- ClinicalTrials.gov ID
- NCT06170580
- Acronym / sponsor ID
- CAS-iFLOW / 114554
- Conditions
- Carotid Artery Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 14 Dec 2023 (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.
Objective: To evaluate the technical performance of a novel cascaded wave imaging technique compared to plane wave imaging for blood flow imaging in patients with and without carotid artery stenosis.
Study design: Observational, feasibility study in a total of 10 patients with and 10 patients without a hemodynamic significant carotid artery plaque.
Intervention (observational): all participants will undergo a carotid ultrasound measurement including conventional duplex ultrasound and ultrasound based flow imaging using plane waves and cascaded waves.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with a hemodynamic significant carotid artery stenosis | – | Diagnostic Test: Conventional duplex, Diagnostic Test: Ultrasound-based flow imaging using plane wave imaging, Diagnostic Test: Ultrasound-based flow imaging using cascaded wave imaging |
| Participants without a hemodynamic significant carotid artery stenosis | – | Diagnostic Test: Conventional duplex, Diagnostic Test: Ultrasound-based flow imaging using plane wave imaging, Diagnostic Test: Ultrasound-based flow imaging using cascaded wave imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients with and 10 patients without a hemodynamic significant carotid artery stenosis
Key inclusion criteria (3 listed)
- Capacitated adult male or female (≥18 years old);
- Informed consent form understood and signed;
- Recent conventional duplex measurement of the carotid artery confirming either the absence or presence of a plaque
Key exclusion criteria (3 listed)
- Hampered carotid blood flow imaging during conventional duplex/doppler measurements due to near to total carotid occlusion at the side of interest or a calcified plaque;
- History of radiation at the head-neck area;
- 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 |
|---|---|---|
| Conventional duplexConventional carotid duplex measurement | Diagnostic test | Participants with a hemodynamic significant carotid artery stenosis, Participants without a hemodynamic significant carotid artery stenosis |
| Ultrasound-based flow imaging using plane wave imagingUltrasound-based flow imaging using plane wave imaging | Diagnostic test | Participants with a hemodynamic significant carotid artery stenosis, Participants without a hemodynamic significant carotid artery stenosis |
| Ultrasound-based flow imaging using cascaded wave imagingUltrasound-based flow imaging using cascaded wave imaging | Diagnostic test | Participants with a hemodynamic significant carotid artery stenosis, Participants without a hemodynamic significant carotid artery stenosis |
Primary outcome
2D velocity vector fields obtained by plane wave and cascaded wave imaging of the carotid artery
Time frame: After study completion, average of one year
5 secondary outcomes
Signal-to-noise ratio obtained from plane wave and cascaded wave imaging will be obtained and compared for different vessel depths
Time frame: After study completion, average of one year
Cross-correlation maps of plane wave and cascaded wave imaging will be obtained and compared for different vessel depths
Time frame: After study completion, average of one year
Velocity vector fields obtained from plane wave and cascaded wave imaging will be obtained and compared
Time frame: After study completion, average of one year
Blood-flow related parameters, including vector complexity and vorticity, will be calculated from 2D velocity fields.
Time frame: After study completion, average of one year
Spatiotemporal blood flow profiles obtained with plane wave, cascaded wave and conventional duplex ultrasound will be compared to assess the correlation between these techniques
Time frame: After study completion, average of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 41217908de Bakker JMK, Ruisch J, de Korte CL, Saris AECM. Cascaded Plane Wave Ultrasound Velocity Vector Imaging: In Vivo Feasibility in Carotid Arteries. IEEE Trans Ultrason Ferroelectr Freq Control. 2025 Dec;72(12):1607-1617. doi: 10.1109/TUFFC.2025.3631658.
- 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.
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 Radboud University Medical Center at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Mar 2025. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
2D velocity vector fields obtained by plane wave and cascaded wave imaging of the carotid artery (time frame: After study completion, average of one year). 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 NCT06170580, 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 21 Mar 2025.