Blood Flow Evaluation After Carotid Surgical Treatment

NCT06827509 | Not Yet Recruiting

• 1 other identifier: 2024-2578
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Wall shear stress

  6-8 weeks after CEA

• Vortex identification

  6-8 weeks after CEA

• Vector complexity

  6-8 weeks after CEA

Study Arms (2)

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

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

Interventions

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.

Also known as: Velocity vector imaging, Ultrafast flow imaging

CEA with eversion technique (ET); CEA with patch repair (CEAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead
• Elisabeth-TweeSteden Ziekenhuis: collaborator
• Medisch Spectrum Twente: collaborator
• Radboud University Medical Center: collaborator
• University of Twente: collaborator

Study Officials

• Michel M.P.J. Reijnen, MD, PhD

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J. Ruisch, Msc

CONTACT

088 005 7282; jruisch@rijnstate.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: April 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-08