Blood Flow Evaluation After Carotid Surgical Treatment

NCT ID: NCT06827509

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-04-01

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.

Conditions

Carotid Endarterectomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Ultrasound-based flow imaging

Intervention Type: DIAGNOSTIC_TEST

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

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.

Ultrasound-based flow imaging

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Velocity vector imaging; Ultrafast flow imaging

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elisabeth-TweeSteden Ziekenhuis

OTHER

Sponsor Role: collaborator

Medisch Spectrum Twente

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

University of Twente

OTHER

Sponsor Role: collaborator

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel M.P.J. Reijnen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Central Contacts

J. Ruisch, Msc

Role: CONTACT

jruisch@rijnstate.nl

088 005 7282

Other Identifiers

2024-2578

Identifier Type: -

Identifier Source: org_study_id