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NCT Number: NCT06827509

Blood Flow Evaluation After Carotid Surgical Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent
  • Carotid artery <25mm below skin

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

Treatment and study plan

Ultrasound-based flow imaging

Diagnostic Test

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

Other names: Velocity vector imaging, Ultrafast flow imaging

Primary outcomes

  1. 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.

Secondary outcomes

  1. Wall shear stress

    Time frame: 6-8 weeks after CEA

    Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is wall shear stress.

  2. Vortex identification

    Time frame: 6-8 weeks after CEA

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

  3. Vector complexity

    Time frame: 6-8 weeks after CEA

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

Study contacts

Contact information is provided by the study sponsor or research team.

J. Ruisch, Msc

CONTACT

[email protected]

088 005 7282

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • Elisabeth-TweeSteden Ziekenhuis
  • Medisch Spectrum Twente
  • Radboud University Medical Center
  • University of Twente

Registry information

Official study title

Blood Flow Evaluation After Carotid Surgical Treatment: Carotid Endarterectomy With Patch Repair Versus Eversion Technique

Acronym: BEAT

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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