Carotid EndarterectomyBEATNCT06827509
Blood Flow Evaluation After Carotid Surgical Treatment
An observational study of Carotid Endarterectomy, run by Rijnstate Hospital.
Trial summary
Approximately 20% of strokes originate from the rupture of an atherosclerotic plaque in the carotid artery. Surgical revascularization, i.e. carotid endarterectomy (CEA), is the treatment of choice for patients with a symptomatic carotid stenosis each year about 3,000 procedures are performed in the Netherlands. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Endarterectomy
- What is being tested?
- Ultrasound-based flow imaging
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Apr 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 that underwent a CEA, without residual stenosis after surgery, will be included in this study. Patients with ET will be recruited in two collaborating hospitals (ETZ and MST) at the department of Vascular Surgery. Participants to the CAP-VALUE trial (Rijnstate and Radboud) are included, where already ultrasound measurements after CEAP were acquired.
Who may be able to join
- Presence of carotid artery stenosis (≥50%) according to conventional clinically performed imaging (duplex/CT(A)/MR(A)) for which patient underwent uncomplicated CEA with either a patch plasty or the eversion technique
- ≥18 years old;
- Able to provide signed or oral informed consent
- Carotid artery <25mm below skin
Who cannot join
- Carotid bifurcation with depth of center bulb lumen ≥2.5cm
- Restenosis after carotid revascularisation at side of interest
- Participating in another clinical study, interfering on outcomes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Blood Flow Evaluation After Carotid Surgical Treatment: Carotid Endarterectomy With Patch Repair Versus Eversion Technique
Approximately 20% of strokes originate from the rupture of an atherosclerotic plaque in the carotid artery. Surgical revascularization, i.e. carotid endarterectomy (CEA), is the treatment of choice for patients with a symptomatic carotid stenosis each year about 3,000 procedures are performed in the Netherlands. Currently, two surgical procedures are performed in clinical practice. Most frequently an endarterectomy is performed using a length incision over the artery, followed by a patch plasty (CEAP), in order to reduce the risk of restenosis. As an alternative the eversion technique (ET) was introduced, in which transversal arteriotomy is performed and the plaque is removed from within. After reconstruction with a patch a >50% restenosis has been described in 6-36% of patients during long-term follow-up. When using the eversion technique this is seen in 1.7-2.5%, while also the risk on adverse events seem to be lower. One of the drivers for atherosclerosis in general is a disturbance of local blood flow. This may lead to turbulence, recirculation and stasis of blood. The subsequent low Wall Shear Stress may lead to the ne formation of plaque that in turn may become instable and cause recurrent ischemic events. Recently, a breakthrough was achieved in the imaging options of flow in the carotid arteries, using Vector Flow Imaging. Using a fully programmable ultrasound machine, over 10,000 frames per second can be captured, in comparison to about 50 in regular ultrasound. This enables the tracking of particles that, after processing will provide the needed flow information. A recent study, comparing flow before and after CEAP has shown that there is significant recirculation after reconstruction. This raises the question whether this would be more optimal after ET, which would support the potential lower incidence of recurrent stenosis.
- Conditions
- Carotid Endarterectomy
- Being tested
- Ultrasound-based flow imaging
- Keywords
- Ultrafast ultrasound flow imaging, Velocity vector imaging, Carotid endarterectomy, Patch repair, Eversion technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-based flow imagingDiagnostic test
Also called Velocity vector imaging, Ultrafast flow imaging
Ultrasound-based flow imaging (based on blood speckle tracking) of the carotid artery will be acquired at 6-8 weeks after surgery.
| Study group | Role | What they receive |
|---|---|---|
| CEA with patch repair (CEAP) | Patients with a carotid artery stenosis that underwent recent conventional carotid endarterectomy with patch repair. Ultrasound measurements were performed 6-8 weeks after CEAP. Receives: Diagnostic Test: Ultrasound-based flow imaging | |
| CEA with eversion technique (ET) | Patients with a carotid artery stenosis that underwent recent carotid endarterectomy with the eversion technique. Ultrasound measurements were performed 6-8 weeks after CEAP. Receives: Diagnostic Test: Ultrasound-based flow imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
2D spatio-temporal blood flow velocity profiles
2D vector velocity fields derived from the US-based flow images will be used to calculate the spatio-temporal blood flow velocities.
Measured: 6-8 weeks after CEA
Secondary outcomes (3)
Wall shear stress
Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is wall shear stress.
Measured: 6-8 weeks after CEA
Vortex identification
Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is vortex identification.
Measured: 6-8 weeks after CEA
Vector complexity
Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is vector complexity.
Measured: 6-8 weeks after CEA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid EndarterectomyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Elisabeth-TweeSteden Ziekenhuis, Medisch Spectrum Twente, Radboud University Medical Center, University of Twente
- Responsible party
- Sponsor
- Investigators
- Michel M.P.J. Reijnen, MD, PhD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827509
- Sponsor's protocol ID
- 2024-2578
- Acronym
- BEAT
- Status last verified
- Aug 2025
- First submitted
- 10 Feb 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Evaluation After Carotid Surgical Treatment: Carotid Endarterectomy With Patch Repair Versus Eversion Technique
- ClinicalTrials.gov ID
- NCT06827509
- Acronym / sponsor ID
- BEAT / 2024-2578
- Conditions
- Carotid Endarterectomy
- Keywords
- Ultrafast ultrasound flow imaging, Velocity vector imaging, Carotid endarterectomy, Patch repair, Eversion technique
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Elisabeth-TweeSteden Ziekenhuis, Medisch Spectrum Twente, Radboud University Medical Center, University of Twente
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 14 Feb 2025 (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.
Approximately 20% of strokes originate from the rupture of an atherosclerotic plaque in the carotid artery. Surgical revascularization, i.e. carotid endarterectomy (CEA), is the treatment of choice for patients with a symptomatic carotid stenosis each year about 3,000 procedures are performed in the Netherlands. Currently, two surgical procedures are performed in clinical practice. Most frequently an endarterectomy is performed using a length incision over the artery, followed by a patch plasty (CEAP), in order to reduce the risk of restenosis. As an alternative the eversion technique (ET) was introduced, in which transversal arteriotomy is performed and the plaque is removed from within. After reconstruction with a patch a >50% restenosis has been described in 6-36% of patients during long-term follow-up. When using the eversion technique this is seen in 1.7-2.5%, while also the risk on adverse events seem to be lower. One of the drivers for atherosclerosis in general is a disturbance of local blood flow. This may lead to turbulence, recirculation and stasis of blood. The subsequent low Wall Shear Stress may lead to the ne formation of plaque that in turn may become instable and cause recurrent ischemic events. Recently, a breakthrough was achieved in the imaging options of flow in the carotid arteries, using Vector Flow Imaging. Using a fully programmable ultrasound machine, over 10,000 frames per second can be captured, in comparison to about 50 in regular ultrasound. This enables the tracking of particles that, after processing will provide the needed flow information. A recent study, comparing flow before and after CEAP has shown that there is significant recirculation after reconstruction. This raises the question whether this would be more optimal after ET, which would support the potential lower incidence of recurrent stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEA with patch repair (CEAP) | – | Diagnostic Test: Ultrasound-based flow imagingPatients with a carotid artery stenosis that underwent recent conventional carotid endarterectomy with patch repair. Ultrasound measurements were performed 6-8 weeks after CEAP. |
| CEA with eversion technique (ET) | – | Diagnostic Test: Ultrasound-based flow imagingPatients with a carotid artery stenosis that underwent recent carotid endarterectomy with the eversion technique. Ultrasound measurements were performed 6-8 weeks after CEAP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that underwent a CEA, without residual stenosis after surgery, will be included in this study. Patients with ET will be recruited in two collaborating hospitals (ETZ and MST) at the department of Vascular Surgery. Participants to the CAP-VALUE trial (Rijnstate and Radboud) are included, where already ultrasound measurements after CEAP were acquired.
Key inclusion criteria (4 listed)
- Presence of carotid artery stenosis (≥50%) according to conventional clinically performed imaging (duplex/CT(A)/MR(A)) for which patient underwent uncomplicated CEA with either a patch plasty or the eversion technique
- ≥18 years old;
- Able to provide signed or oral informed consent
- Carotid artery <25mm below skin
Key exclusion criteria (3 listed)
- Carotid bifurcation with depth of center bulb lumen ≥2.5cm
- Restenosis after carotid revascularisation at side of interest
- 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 imagingAlso: Velocity vector imaging, Ultrafast flow imagingUltrasound-based flow imaging (based on blood speckle tracking) of the carotid artery will be acquired at 6-8 weeks after surgery. | Diagnostic test | CEA with eversion technique (ET), CEA with patch repair (CEAP) |
Primary outcome
2D spatio-temporal blood flow velocity profiles
Time frame: 6-8 weeks after CEA
2D vector velocity fields derived from the US-based flow images will be used to calculate the spatio-temporal blood flow velocities.
3 secondary outcomes
Wall shear stress
Time frame: 6-8 weeks after CEA
Vortex identification
Time frame: 6-8 weeks after CEA
Vector complexity
Time frame: 6-8 weeks after CEA
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 5 Aug 2025.
- 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.
Michel M.P.J. Reijnen, MD, PhD principal investigator
Rijnstate Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Endarterectomy, run by Rijnstate Hospital.
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 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: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact J. Ruisch, Msc (088 005 7282, jruisch@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2D spatio-temporal blood flow velocity profiles (time frame: 6-8 weeks after CEA). 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 5 Aug 2025.