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Starting soon Observational

Research on Ultrasound Diagnostic Criteria for Intracranial and Extracranial Arterial Serial Stenosis

NCT06947720 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-09-01
Last updated
2025-08-15

Condition(s) studied

Ischemic StrokeCarotid Stenosis

Investigational drug(s) / intervention(s)

stenting

stenting: All 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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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; 2. Perform stent placement surgery within 2 weeks of ultrasound examination, and perform DSA and CTA examinations; 3. Age ≥ 18 years old; 4. Clinical data is complete. Exclusion Criteria: 1. Bilateral temporal windows are not transparent to sound; 2. 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; 3. Patients with severe stenosis of the extracranial segment of the internal carotid artery have severe stenosis of the contralateral carotid artery; 4. Patients with severe stenosis or occlusion of the anterior circulation in the initial segment of unilateral vertebral artery; 5. Severe stenosis or occlusion of bilateral subclavian arteries; 6. Vasospasm caused by subarachnoid hemorrhage, etc; 7. Related MCA or vertebral artery thrombolysis or endovascular treatment; 8. Arrhythmias such as atrial fibrillation or heart failure that affect velocity measurement; 9. CT, MRI, DSA examination contraindications or refusal of examination; 10. Severe bleeding disorders or coagulation dysfunction; 11. Merge serious diseases of other organs or tissues.

Primary outcome measure(s)

  • Ultrasound diagnostic criteria for serial stenosis — From preoperative TCCD assessment to surgical completion
    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
  • The occurrence of the endpoint event — Within 1 year after surgery
    At the 1-year follow-up after surgery, whether ischemic stroke, transient ischemic attack, and hemorrhagic stroke occurred.

Trial sites (1)

FacilityCityRegionStatus
Department of Vascular Ultrasound, Xuanwu Hospital, Capital Medical University Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06947720 on ClinicalTrials.gov ↗ ← All trials in China