Clinical trial NCT06827509: Blood Flow Evaluation After Carotid Surgical Treatment
Official title: Blood Flow Evaluation After Carotid Surgical Treatment: Carotid Endarterectomy With Patch Repair Versus Eversion Technique
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Carotid Endarterectomy
Keywords: Ultrafast ultrasound flow imaging
Velocity vector imaging
Carotid endarterectomy
Patch repair
Eversion technique
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Elisabeth-TweeSteden Ziekenhuis
name: Medisch Spectrum Twente
name: Radboud University Medical Center
name: University of Twente
First posted: 2025-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: 2D spatio-temporal blood flow velocity profiles
timeFrame: 6-8 weeks after CEA
Secondary outcomes:
measure: Wall shear stress
timeFrame: 6-8 weeks after CEA
measure: Vortex identification
timeFrame: 6-8 weeks after CEA
measure: Vector complexity
timeFrame: 6-8 weeks after CEA
Other outcomes:
Locations:
Study officials:
affiliation: Rijnstate Hospital
name: Michel M.P.J. Reijnen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: