Blood Flow Evaluation After Carotid Surgical Treatment (BEAT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carotid Endarterectomy
• Intervention / Treatment: Diagnostic test: Ultrasound-based flow imaging

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: J. Ruisch, Msc; Phone Number: 088 005 7282; Email: jruisch@rijnstate.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6-8 weeks after CEA

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	6-8 weeks after CEA

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: Radboud University Medical Center; Elisabeth-TweeSteden Ziekenhuis; University of Twente; Medisch Spectrum Twente
• Investigators: Principal Investigator: Michel M.P.J. Reijnen, MD, PhD, Rijnstate Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Carotid endarterectomy; Ultrafast ultrasound flow imaging; Velocity vector imaging; Patch repair; Eversion technique
• Other Study ID Numbers: 2024-2578

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No