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Blood Flow Evaluation After Carotid Surgical Treatment

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06827509
Acronym
BEAT
Enrollment
40
Registered
2025-02-14
Start date
2025-09-01
Completion date
2026-04-01
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Endarterectomy

Keywords

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

Brief 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.

Interventions

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

Sponsors

Elisabeth-TweeSteden Ziekenhuis
CollaboratorOTHER
Medisch Spectrum Twente
CollaboratorOTHER
Radboud University Medical Center
CollaboratorOTHER
University of Twente
CollaboratorOTHER
Rijnstate Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
2D spatio-temporal blood flow velocity profiles6-8 weeks after CEA2D vector velocity fields derived from the US-based flow images will be used to calculate the spatio-temporal blood flow velocities.

Secondary

MeasureTime frameDescription
Wall shear stress6-8 weeks after CEAMultiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is wall shear stress.
Vortex identification6-8 weeks after CEAMultiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is vortex identification.
Vector complexity6-8 weeks after CEAMultiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is vector complexity.

Contacts

Primary ContactJ. Ruisch, Msc
jruisch@rijnstate.nl088 005 7282

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026