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Blood Flow Evaluation After Carotid Surgical Treatment

NCT06827509 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-08-05

No results posted yet for this 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.

Conditions

  • Carotid Endarterectomy

Interventions

DIAGNOSTIC_TEST

Ultrasound-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.

Sponsors & Collaborators

  • Elisabeth-TweeSteden Ziekenhuis

    collaborator OTHER

  • Medisch Spectrum Twente

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • University of Twente

    collaborator OTHER

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • Michel M.P.J. Reijnen, MD, PhD · Rijnstate Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-12-31
Completion
2026-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06827509 on ClinicalTrials.gov