Blood Flow Evaluation After Carotid Surgical Treatment

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRijnstate Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: CEA with patch repair (CEAP)1 intervention
Group B: CEA with eversion technique (ET)1 intervention

Trial outcomes

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.

Time frame
6-8 weeks after CEA

Secondary outcomes

1

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.

Time frame
6-8 weeks after CEA
2

Vortex identification

Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is vortex identification.

Time frame
6-8 weeks after CEA
3

Vector complexity

Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is vector complexity.

Time frame
6-8 weeks after CEA

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rijnstate Hospital

Lead sponsor

Elisabeth-TweeSteden Ziekenhuis

Collaborator

Medisch Spectrum Twente

Collaborator

Radboud University Medical Center

Collaborator

University of Twente

Collaborator

This trial is not recruiting at the moment. You can still explore other options: