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

NCT06947720 | Not Yet Recruiting DMC

• 1 other identifier: xwzc202500203
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke; Carotid Stenosis

Keywords

Serial stenosis; hemodynamics; Ultrasound diagnostic criteria; prediction model

Outcome Measures

Primary Outcomes (2)

• 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

  From preoperative TCCD assessment to surgical completion

• The occurrence of the endpoint event

  At the 1-year follow-up after surgery, whether ischemic stroke, transient ischemic attack, and hemorrhagic stroke occurred.

  Within 1 year after surgery

Study Arms (10)

Mild stenosis group without collateral circulation

There is no anterior communicating artery, posterior communicating artery, or internal external carotid artery in the skull, and the degree of stenosis in the V4 segment of the middle cerebral artery or vertebral artery is less than 50%

Procedure: stenting

Group without collateral circulation and stenosis

There is no anterior communicating artery, posterior communicating artery, or internal carotid external artery in the skull, and there is no stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery.

Procedure: stenting

Moderate stenosis group without collateral circulation

There is no anterior communicating artery, posterior communicating artery, or internal carotid external artery in the skull, and the degree of stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery is 50-69%.

Procedure: stenting

Severe stenosis group without collateral circulation

There is no anterior communicating artery, posterior communicating artery, or internal carotid external artery in the skull, and the degree of stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery is 70-99%.

Procedure: stenting

Group with collateral circulation and no stenosis

There are anterior or posterior communicating arteries or internal external carotid arteries in the skull, and there is no stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery.

Procedure: stenting

Mild stenosis of collateral circulation group

There are anterior or posterior communicating arteries or internal external carotid arteries in the skull, and the degree of stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery is less than 50%.

Procedure: stenting

Moderate stenosis of collateral circulation group

There are anterior or posterior communicating arteries or internal external carotid arteries in the skull, and the degree of stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery is 50-69%.

Procedure: stenting

Group with severe stenosis of collateral circulation

There are anterior or posterior communicating arteries or internal external carotid arteries in the skull, and the degree of stenosis in the V4 segment of the affected middle cerebral artery or vertebral artery is 70-99%.

Procedure: stenting

End event group

During the 1-year follow-up after surgery, the patient experienced new stroke events such as ischemic stroke, transient ischemic attack, and hemorrhagic stroke.

Procedure: stenting

Group without endpoint events

At the 1-year follow-up after surgery, the patient did not experience any new stroke events such as ischemic stroke, transient ischemic attack, or hemorrhagic stroke.

Procedure: stenting

Interventions

stenting PROCEDURE

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.

End event group; Group with collateral circulation and no stenosis; Group with severe stenosis of collateral circulation; Group without collateral circulation and stenosis; Group without endpoint events; Mild stenosis group without collateral circulation; Mild stenosis of collateral circulation group; Moderate stenosis group without collateral circulation; Moderate stenosis of collateral circulation group; Severe stenosis group without collateral circulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Severe stenosis or occlusion of bilateral subclavian arteries;
• Vasospasm caused by subarachnoid hemorrhage, etc;
• Related MCA or vertebral artery thrombolysis or endovascular treatment;
• Arrhythmias such as atrial fibrillation or heart failure that affect velocity measurement;
• CT, MRI, DSA examination contraindications or refusal of examination;
• Severe bleeding disorders or coagulation dysfunction;
• Merge serious diseases of other organs or tissues.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Department of Vascular Ultrasound, Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (5)

• Du B, Wong EH, Jiang WJ. Long-term outcome of tandem stenting for stenoses of the intracranial vertebrobasilar artery and vertebral ostium. AJNR Am J Neuroradiol. 2009 Apr;30(4):840-4. doi: 10.3174/ajnr.A1427. Epub 2009 Mar 11.

  PMID: 19279273 BACKGROUND

• Ballotta E, Toniato A, Da Roit A, Baracchini C. Clinical Outcomes of Carotid Endarterectomy in Symptomatic and Asymptomatic Patients with Ipsilateral Intracranial Stenosis. World J Surg. 2015 Nov;39(11):2823-30. doi: 10.1007/s00268-015-3165-7.

  PMID: 26243559 BACKGROUND

• Ryu JC, Lee SH, Yoo JS, Kwon B, Song Y, Lee DH, Bae JH, Chang JY, Kang DW, Kwon SU, Kim JS, Kim BJ. Prognosis of Proximal and Distal Vertebrobasilar Artery Stent Placement. AJNR Am J Neuroradiol. 2024 Nov 7;45(11):1685-1691. doi: 10.3174/ajnr.A8389.

  PMID: 39389775 BACKGROUND

• Zhang J, Xing Y, Cui L. Duplex Ultrasonography for the Evaluation of Extracranial Vertebral Artery: A Prospective Comparison With Digital Subtraction Angiography. Front Neurol. 2022 Jun 27;13:814972. doi: 10.3389/fneur.2022.814972. eCollection 2022.

  PMID: 35832174 BACKGROUND

• Liu S, Huang ZL, Sun YR, Liu L, Qi H, Wei LY. Application value of transcranial contrast-enhanced ultrasonography in evaluating middle cerebral artery stenosis. Eur Rev Med Pharmacol Sci. 2023 Jan;27(1):224-232. doi: 10.26355/eurrev_202301_30875.

  PMID: 36647872 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Carotid Stenosis

Interventions

Stents

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Yingqi Xing

  Vascular Ultrasound Diagnosis Department, Xuanwu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingqi Xing

CONTACT

+8618610047846; xingyq2009@sina.com

Songwei Chen

CONTACT

+8615896921765; csw1021@sina.cn

Study Design

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

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 27, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)