Ischemic StrokeNCT06947720
Research on Ultrasound Diagnostic Criteria for Intracranial and Extracranial Arterial Serial Stenosis
An observational study of Ischemic Stroke and Carotid Stenosis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Carotid Stenosis
- What is being tested?
- stenting
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Vascular Ultrasound, Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Ying-qi Xing, +8618610047846, xingyq2009@sina.com
Song-wei Chen, +8615896921765, csw1021@sina.cn
About this study
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.
Read the detailed description
This study retrospectively and consecutively enrolled 700 patients diagnosed with either 1) severe extracranial internal carotid artery stenosis combined with ipsilateral middle cerebral artery (MCA) tandem stenosis, or 2) unilateral severe vertebral artery (VA) origin stenosis combined with intracranial V4 segment tandem stenosis, who underwent carotid artery stenting or vertebral artery stenting at our institution. Demographic information, vascular ultrasound findings, and imaging examination results were collected and recorded. All enrolled patients underwent a 1-year follow-up investigation. Follow-up data included vascular ultrasound results, laboratory test results, imaging findings, clinical symptoms (ischemic stroke, transient ischemic attack, hemorrhagic stroke), and documentation of endpoint events. The primary endpoint was the 12-month incidence of new-onset stroke events, defined as ischemic stroke, transient ischemic attack, or hemorrhagic stroke.
The study utilized transcranial color-coded Doppler (TCCD) and transcranial Doppler (TCD) hemodynamic parameters to ultrasonically grade MCA stenosis severity in patients with severe extracranial internal carotid artery stenosis and intracranial V4 segment stenosis severity in patients with severe VA origin stenosis. The goal was to establish ultrasound diagnostic criteria and provide a reference basis for clinical treatment decision-making. Additionally, the distribution of stroke risk factors was analyzed, and a risk identification and prediction model for stroke was developed and evaluated.
Patients were first stratified into two groups based on the presence or absence of collateral circulation. Further subgroup classification was performed according to the degree of MCA stenosis (on digital subtraction angiography [DSA]) or V4 segment stenosis: no stenosis, mild stenosis, moderate stenosis, and severe stenosis. Finally, patients were categorized into either the endpoint event group or the non-event group based on the occurrence of endpoint events during follow-up.
- Conditions
- Ischemic Stroke, Carotid Stenosis
- Being tested
- stenting
- Keywords
- Serial stenosis, hemodynamics, Ultrasound diagnostic criteria, prediction model
- Medical subject headings
- Ischemic Stroke, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stentingProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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% Receives: 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. Receives: 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%. Receives: 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%. Receives: 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. Receives: 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%. Receives: 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%. Receives: 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%. Receives: 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. Receives: 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. Receives: Procedure: stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Within 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingqi Xing, Principal investigator, Vascular Ultrasound Diagnosis Department, Xuanwu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947720
- Sponsor's protocol ID
- xwzc202500203
- Status last verified
- Aug 2025
- First submitted
- 20 Apr 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19279273Ballotta 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.
PubMed 26243559Ryu 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.
PubMed 39389775Zhang 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.
PubMed 35832174Liu 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.
PubMed 36647872
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Ultrasound Diagnostic Criteria for Intracranial and Extracranial Arterial Serial Stenosis
- ClinicalTrials.gov ID
- NCT06947720
- Acronym / sponsor ID
- xwzc202500203
- Conditions
- Ischemic Stroke, Carotid Stenosis
- Keywords
- Serial stenosis, hemodynamics, Ultrasound diagnostic criteria, prediction model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study retrospectively and consecutively enrolled 700 patients diagnosed with either 1) severe extracranial internal carotid artery stenosis combined with ipsilateral middle cerebral artery (MCA) tandem stenosis, or 2) unilateral severe vertebral artery (VA) origin stenosis combined with intracranial V4 segment tandem stenosis, who underwent carotid artery stenting or vertebral artery stenting at our institution. Demographic information, vascular ultrasound findings, and imaging examination results were collected and recorded. All enrolled patients underwent a 1-year follow-up investigation. Follow-up data included vascular ultrasound results, laboratory test results, imaging findings, clinical symptoms (ischemic stroke, transient ischemic attack, hemorrhagic stroke), and documentation of endpoint events. The primary endpoint was the 12-month incidence of new-onset stroke events, defined as ischemic stroke, transient ischemic attack, or hemorrhagic stroke.
The study utilized transcranial color-coded Doppler (TCCD) and transcranial Doppler (TCD) hemodynamic parameters to ultrasonically grade MCA stenosis severity in patients with severe extracranial internal carotid artery stenosis and intracranial V4 segment stenosis severity in patients with severe VA origin stenosis. The goal was to establish ultrasound diagnostic criteria and provide a reference basis for clinical treatment decision-making. Additionally, the distribution of stroke risk factors was analyzed, and a risk identification and prediction model for stroke was developed and evaluated.
Patients were first stratified into two groups based on the presence or absence of collateral circulation. Further subgroup classification was performed according to the degree of MCA stenosis (on digital subtraction angiography [DSA]) or V4 segment stenosis: no stenosis, mild stenosis, moderate stenosis, and severe stenosis. Finally, patients were categorized into either the endpoint event group or the non-event group based on the occurrence of endpoint events during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Mild stenosis group without collateral circulation | – | Procedure: stentingThere 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% |
| Group without collateral circulation and stenosis | – | Procedure: stentingThere 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. |
| Moderate stenosis group without collateral circulation | – | Procedure: stentingThere 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%. |
| Severe stenosis group without collateral circulation | – | Procedure: stentingThere 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%. |
| Group with collateral circulation and no stenosis | – | Procedure: stentingThere 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. |
| Mild stenosis of collateral circulation group | – | Procedure: stentingThere 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%. |
| Moderate stenosis of collateral circulation group | – | Procedure: stentingThere 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%. |
| Group with severe stenosis of collateral circulation | – | Procedure: stentingThere 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%. |
| End event group | – | Procedure: stentingDuring the 1-year follow-up after surgery, the patient experienced new stroke events such as ischemic stroke, transient ischemic attack, and hemorrhagic stroke. |
| Group without endpoint events | – | Procedure: stentingAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stentingAll 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. | Procedure or surgery | 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 |
Primary outcome
Ultrasound diagnostic criteria for serial stenosis
Time frame: 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
Time frame: Within 1 year after surgery
At the 1-year follow-up after surgery, whether ischemic stroke, transient ischemic attack, and hemorrhagic stroke occurred.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Background: PubMed 19279273Du 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.
- Background: PubMed 26243559Ballotta 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.
- Background: PubMed 39389775Ryu 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.
- Background: PubMed 35832174Zhang 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.
- Background: PubMed 36647872Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yingqi Xing principal investigator
Vascular Ultrasound Diagnosis Department, Xuanwu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Carotid Stenosis, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yingqi Xing (+8618610047846, xingyq2009@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound diagnostic criteria for serial stenosis (time frame: From preoperative TCCD assessment to surgical completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06947720, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.