ClinicalTrials.gg
Not yet recruitingNCT06827509BEATUpdated Aug 5, 2025

Blood Flow Evaluation After Carotid Surgical Treatment

An observational study in Carotid Endarterectomy, sponsored by Rijnstate Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by Rijnstate Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Carotid Endarterectomy

Keywords

  • Ultrafast ultrasound flow imaging
  • Velocity vector imaging
  • Carotid endarterectomy
  • Patch repair
  • Eversion technique
03

In context

Lead sponsor

Rijnstate Hospital is the lead sponsor of 130 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • Carotid artery \<25mm below skin

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Diagnostic Test: Ultrasound-based flow imaging

Interventions

  • Diagnostic testUltrasound-based flow imaging

    Ultrasound-based flow imaging (based on blood speckle tracking) of the carotid artery will be acquired at 6-8 weeks after surgery.

    Also known as: Velocity vector imaging, Ultrafast flow imaging

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6-8 weeks after CEA

Secondary outcomes

  1. 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.

    Time frame: 6-8 weeks after CEA

  2. Vortex identification

    Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is vortex identification.

    Time frame: 6-8 weeks after CEA

  3. Vector complexity

    Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is vector complexity.

    Time frame: 6-8 weeks after CEA

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06827509
Lead sponsor
Rijnstate Hospital
Collaborators
Elisabeth-TweeSteden Ziekenhuis, Medisch Spectrum Twente, Radboud University Medical Center, University of Twente
Responsible party
Sponsor
First posted
Feb 14, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
Aug 5, 2025

Study contacts

J. Ruisch, Msc
Contact
jruisch@rijnstate.nl
088 005 7282
Michel M.P.J. Reijnen, MD, PhD
principal investigator · Rijnstate Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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