Research on Ultrasound Diagnostic Criteria for Intracranial and Extracranial Arterial Serial Stenosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing
About this trial
This study utilized different hemodynamic parameters of transcranial color-coded Doppler (TCCD) and transcranial Doppler (TCD) to conduct ultrasonic grading evaluation on middle cerebral artery (MCA) stenosis severity in patients with severe extracranial internal carotid artery stenosis, as well as intracranial V4 segment stenosis severity in patients with severe vertebral artery (VA) origin stenosis. The aim was to establish ultrasonic diagnostic criteria and provide reference basis for clinical treatment decision-making. Clarify the distribution of stroke risk factors, establish and evaluate stroke risk identification and prediction models. Patient cohort: Individuals undergoing carotid artery stenting or vertebral artery stenting, including those with either 1) severe extracranial internal carotid artery stenosis combined with ipsilateral MCA tandem stenosis, or 2) unilateral severe vertebral artery origin stenosis combined with intracranial V4 segment tandem stenosis. Collected data included demographic information, vascular ultrasound findings, and imaging examination results. All patients underwent a 1-year follow-up investigation documenting follow-up vascular ultrasound results, laboratory test results, imaging findings, clinical symptoms (ischemic stroke, transient ischemic attack, hemorrhagic stroke), and occurrence of endpoint events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed by carotid ultrasound with severe stenosis of the extracranial segment of the internal carotid artery or severe stenosis of the initial segment of the unilateral vertebral artery;
Perform stent placement surgery within 2 weeks of ultrasound examination, and perform DSA and CTA examinations;
Age ≥ 18 years old;
Clinical data is complete.
Disqualifiers
Bilateral temporal windows are not transparent to sound;
Patients with severe stenosis of the extracranial segment of the internal carotid artery have ipsilateral MCA occlusion/ipsilateral common carotid artery severe stenosis or occlusion;
Patients with severe stenosis of the extracranial segment of the internal carotid artery have severe stenosis of the contralateral carotid artery;
Patients with severe stenosis or occlusion of the anterior circulation in the initial segment of unilateral vertebral artery;
Trial population
Male and female patients over 18 years old with severe stenosis of the extracranial segment of the internal carotid artery or severe stenosis of the initial segment of the unilateral vertebral artery, who undergo carotid or vertebral artery stenting
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
stenting
Procedure/SurgeryAll individuals are anesthetized, with local or general anesthesia depending on the patient's level of cooperation. During the surgery, heparin must be injected intravenously to control the activated clotting time between 250-300 seconds. The surgery is performed via the femoral artery, and the choice of stent type and size, as well as any required equipment, are determined by the intervention personnel themselves.
Treatment groups
700 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: Mild stenosis group without collateral circulation1 intervention
Group B: Group without collateral circulation and stenosis1 intervention
Group C: Moderate stenosis group without collateral circulation1 intervention
Group D: Severe stenosis group without collateral circulation1 intervention
Group E: Group with collateral circulation and no stenosis1 intervention
Group F: Mild stenosis of collateral circulation group1 intervention
Group G: Moderate stenosis of collateral circulation group1 intervention
Group H: Group with severe stenosis of collateral circulation1 intervention
Group I: End event group1 intervention
Group J: Group without endpoint events1 intervention
Trial outcomes
Primary outcomes
1
Ultrasound diagnostic criteria for serial stenosis
Ultrasound standards for assessing the degree of stenosis in the ipsilateral middle cerebral artery or vertebral artery V4 segment in patients with severe stenosis of the extracranial segment of the internal carotid artery or the initial segment of the vertebral artery, using different hemodynamic parameters
Time frame
From preoperative TCCD assessment to surgical completion2
The occurrence of the endpoint event
At the 1-year follow-up after surgery, whether ischemic stroke, transient ischemic attack, and hemorrhagic stroke occurred.
Time frame
Within 1 year after surgerySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: