Asymptomatic Carotid Artery StenosisNCT06899399
Efficacy and Safety Study of Endovascular Treatment of Asymptomatic Carotid Artery Stenosis
A study testing Endovascular treatment and Best medical treatment in people with Asymptomatic Carotid Artery Stenosis, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This study is a multicenter, prospective, open-label, endpoint-blinded, randomized controlled trial designed to evaluate the safety and efficacy of endovascular stenting combined with optimal medical therapy versus optimal medical therapy alone in patients with asymptomatic severe stenosis (70-99%) of the internal… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Asymptomatic Carotid Artery Stenosis
- What is being tested?
- Endovascular treatment and Best medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 982 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2024to Jul 2028
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-80 years
- Severe asymptomatic internal carotid artery stenosis (70-99%) confirmed by ultrasound/CTA/DSA
- Contralateral ICA stenosis <70%
- No TIA/stroke related to target lesion in past 6 months
- Declined carotid endarterectomy
- Willing to complete 12-month follow-up
- Signed informed consent by participant/legal representative
Who cannot join
- symptomatic internal carotid artery stenosis in the past 6 months
- Spontaneous intracranial hemorrhage in nearly one year
- Patients with larger intracranial aneurysms (diameter >5 mm) who cannot undergo prior or concurrent treatment
- Chronic occlusion without obvious symptoms of cerebral ischemic attack
- Patients with transient or permanent neurological deficit resulting from Neurological deficits mimicking TIA/stroke from TIA or stroke
- Common carotid artery ostial lesion
Show all 30Show fewer
- Tandem lesions with severe stenosis of the ipsilateral intracranial artery
- Patients with severe dementia
- Internal carotid artery dissection
- Internal carotid artery aneurysm
- Myocardial infarction within 30 days
- Ejection fraction <30% or New York Heart Association (NYHA) functional class III or higher; unstable angina, characterized by angina at rest with electrocardiogram changes
- Cardiogenic embolism, including left ventricular aneurysm, intraluminal filling defects, cardiomyopathy, aortic or mitral valve-prosthetic heart valve, calcified aortic stenosis, infective endocarditis
- Mitral stenosis, atrial septal defect, atrial septal aneurysm or left chamber myxoma
- Two or more proximal or main coronary artery stenosis 70%, untreated or recanable
- Platelets <5 * 104 / uL, INR> 1.5, bleeding time> 1min or heparin-related thrombocytopenia; heparin is a contraindication to antiplatelet drugs; coagulopathy
- Poor controlled diabetes mellitus, fasting blood glucose> 22 mmol/L and ketone body>+2
- Malignant tumor or respiratory insufficiency, and a life expectancy of <5 years
- Severe liver and kidney function impairment, ALT> 3 times the upper limit of normal value or AST> 3 times the upper limit of normal value, blood creatinine increase> 2 times the upper limit of normal value
- Contrast allergy
- Other general anesthesia operations are required during the same period
- Pregnant or lactating women
- The patient does not attend the clinical trial of other drug or medical device before enrollment
- The investigator is not considered fit to participate in this clinical study
- Imaging exclusion criteria:
- Type III aortic arch
- Severe angulation or tortuosity (≥90 degrees) of the common carotid artery or innominate artery that prevents safe and rapid placement of a guiding catheter or long sheath
- Severe angulation or tortuosity of the internal carotid artery that prevents safe deployment of an embolic protection device or stent. Severe tortuosity is defined as the presence of two or more angles ≥90 degrees within 4 cm of the stenotic lesion
- Stenosis of the beginning or proximal end of the common carotid artery, innominate artery, distal or intracranial segment of the internal carotid artery, and the stenosis degree is greater than that of the target stenosis
- The stenotic lesion exhibits severe circumferential calcification, defined as calcification greater than 3 mm in thickness visible in orthogonal views during fluoroscopy. (Note: In elderly subjects aged ≥70 years, anatomical factors such as tortuosity, arch anatomy, and calcification must be assessed more carefully)
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, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing
Dapeng Sun, MD, +8619520064886, sundp1990@163.com
About this study
This study is a multicenter, prospective, open-label, endpoint-blinded, randomized controlled trial designed to evaluate the safety and efficacy of endovascular stenting combined with optimal medical therapy versus optimal medical therapy alone in patients with asymptomatic severe stenosis (70-99%) of the internal carotid artery. The study plans to enroll 982 patients aged 40-80 years who have had no ipsilateral carotid artery-related neurological symptoms in the past six months and who have declined carotid endarterectomy. The primary endpoints include stroke, myocardial infarction, or death within 30 days post-procedure/enrollment, as well as the incidence of ipsilateral stroke from 30 days to one year post-procedure/enrollment. Secondary endpoints include procedural success rate, restenosis rate, changes in cognitive function, and others. The study results will provide high-level evidence-based medical evidence for the treatment selection of patients with asymptomatic carotid artery stenosis.
Read the detailed description
This multicenter, prospective, open-label, randomized controlled trial with blinded endpoint assessment aims to evaluate the safety and efficacy of endovascular stenting combined with best medical therapy (BMT) versus BMT alone in patients with asymptomatic severe stenosis (70-99%) of the internal carotid artery (ICA). The study will enroll 982 participants aged 40-80 years who have no history of ipsilateral transient ischemic attack (TIA), stroke, or related neurological symptoms within the past 6 months and have declined carotid endarterectomy. The primary objective is to determine whether stenting reduces the composite risk of stroke, myocardial infarction, or death within 30 days post-procedure/enrollment, as well as ipsilateral stroke from 30 days to 1 year. Secondary objectives include assessing procedural success, restenosis rates, cognitive outcomes (measured by Montreal Cognitive Assessment [MoCA] and Mini-Mental State Examination [MMSE]), and long-term clinical outcomes.
The trial will be conducted across multiple centers in China, led by Beijing Tiantan Hospital, Capital Medical University. Participants will be randomly assigned (1:1) via a computer-generated stratified randomization scheme to either the intervention group (endovascular stenting plus BMT) or the control group (BMT alone). BMT includes antiplatelet therapy, lipid-lowering agents, blood pressure control, and management of other cardiocerebrovascular risk factors. Endpoint adjudication will be performed by an independent blinded clinical events committee to minimize bias.
Eligible participants must have severe ICA origin stenosis confirmed by ultrasound, computed tomography angiography (CTA), or digital subtraction angiography (DSA), with contralateral ICA stenosis <70%. Key exclusion criteria include recent symptomatic stenosis, intracranial hemorrhage within 1 year, severe cardiopulmonary comorbidities, contraindications to antiplatelet/anticoagulant therapy, life expectancy <5 years, or anatomical challenges (e.g., Type III aortic arch, severe vascular tortuosity/calcification). Imaging exclusions focus on technical feasibility and safety, such as tandem intracranial stenosis or distal lesions more severe than the target stenosis.
The primary endpoints are the 30-day composite rate of stroke, myocardial infarction, or death, and the incidence of ipsilateral stroke between 30 days and 1 year. Secondary endpoints include technical success (defined as residual stenosis <30% with Thrombolysis in Myocardial Infarction [TIMI] grade 3 flow post-procedure), 30-day and 12-month mortality, restenosis rates, and cognitive changes. Statistical analysis will follow the intention-to-treat principle, with Kaplan-Meier survival analysis and log-rank tests for primary outcomes. Cox proportional hazards models will estimate hazard ratios (HRs) with 95% confidence intervals (CIs). Sensitivity analyses will use per-protocol and as-treated populations.
The study duration is scheduled from August 2024 to July 2028, including a 12-month follow-up period. Ethical approval will be obtained from all participating centers, and the trial will adhere to the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.
- Conditions
- Asymptomatic Carotid Artery Stenosis
- Being tested
- Endovascular treatment, Best medical treatment
- Keywords
- Asymptomatic carotid stenosis, Carotid stenting, Best medical therapy, Randomized controlled trial, Stroke prevention, Endovascular treatment, Carotid artery disease, Ischemic stroke
- Medical subject headings
- Carotid Artery Diseases, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatmentProcedure or surgery
Participants will receive carotid artery stenting as the primary intervention. The procedure will be performed via femoral artery access (radial access allowed for anatomically challenging cases) with mandatory use of an embolic protection device (EPD). Stent selection and EPD type will be determined by the operator based on lesion characteristics.
Pre-procedural dual antiplatelet therapy (DAPT: aspirin 100 mg/day + clopidogrel 75 mg/day) will be administered for ≥3-5 days. Post-procedural DAPT will continue for 3 months, transitioning to aspirin monotherapy (100 mg/day) thereafter. Statins and risk factor management (blood pressure、LDL-C, glycemic control) will align with standardized protocols.
Best medical treatmentDrug
Participants will receive intensive medical management, including aspirin (75-325 mg/day) or alternative antiplatelet agents (clopidogrel/dipyridamole) for intolerance. Statin therapy and risk factor control targets (blood pressure, lipids, glucose, lifestyle) will mirror the experimental group. Both groups will undergo regular follow-up for adherence monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Internal carotid artery stenting and medical treatment | Experimental | Not described Receives: Procedure: Endovascular treatment |
| Best Medical Therapy | Active comparator | Not described Receives: Drug: Best medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoint
The primary outcome was a composite of any stroke, myocardial infarction (MI), or all-cause mortality within 30 days post-enrollment or post-procedure, plus ipsilateral stroke between 30 days and 12 months post-enrollment/procedure.
Measured: Within 30 days/ between 30 days and 12 months post-enrollment or post-procedure
Secondary outcomes (13)
Success rate of surgical technique
Success rate of surgical technique (defined as final residual stenosis <30%,TIMI grade 3, no dissection or thrombosis after endovascular treatment)
Measured: Surgery completed
Incidence of myocardial infarction
Incidence of myocardial infarction within 30 days after surgery or within 30 days of enrollment
Measured: Within 30 days after surgery or within 30 days of enrollment
Incidence of ipsilateral stroke
Incidence of ipsilateral stroke within 30 days after surgery or within 30 days of enrollment
Measured: Within 30 days after surgery or within 30 days of enrollment
Incidence of bilateral stroke
Incidence of bilateral stroke within 30 days after surgery or within 30 days of enrollment
Measured: Within 30 days after surgery or within 30 days of enrollment
The incidence of all-cause death
The incidence of all-cause death after surgery or within 30 days of enrollment
Measured: Within 30 days after surgery or within 30 days of enrollment
Cognitive function improvement (MoCA scale)
Cognitive function assessment at 30 days after surgery or within 30 days of enrollment (MoCA scale) (optional)
Measured: Within 30 days after surgery or within 30 days of enrollment
Cognitive improvement (MMSE scale)
Cognitive function assessment (MMSE scale) after surgery or within 30 days of enrollment (optional)
Measured: 30 days after surgery or within 30 days of enrollment
Incidence of ipsilateral stroke
Incidence of ipsilateral stroke at 12 months after surgery or enrollment
Measured: 12 months after surgery or enrollment
The incidence of all-cause death
The incidence of all-cause death at 12 months after surgery or enrollment
Measured: 12 months after surgery or enrollment
Incidence of bilateral stroke
Incidence of bilateral stroke at 12 months after surgery or enrollment
Measured: 12 months after surgery or enrollment
Rate of internal carotid artery restenosis
Rate of internal carotid artery restenosis at 12 months after surgery or enrollment; (Internal carotid artery restenosis definition: Restenosis ≥50% after internal carotid artery stent implantation, peak contraction velocity ratio [PSVR]≥2.0)
Measured: 12 months after surgery or enrollment
Cognitive function improvement (MoCA scale)
Cognitive function assessment at 12 months after surgery or within 12 months of enrollment (MoCA scale) (optional)
Measured: 12 months after surgery or within 12 months of enrollment.
Improvement in cognitive function (MMSE scale)
Improvement in cognitive function (MMSE scale) at 12 months after surgery or enrollment (optional)
Measured: 12 months after surgery or enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start18 Oct 2024
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 982 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Gao, Beijing Tiantan Hospital
- Investigators
- Feng Gao, MD, Principal investigator, Beijing Tiantan HospitalZhongrong Miao, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899399
- Sponsor's protocol ID
- 2023ZD0505400
- Status last verified
- Feb 2025
- First submitted
- 21 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Endovascular Treatment of Asymptomatic Carotid Artery Stenosis
- ClinicalTrials.gov ID
- NCT06899399
- Acronym / sponsor ID
- 2023ZD0505400
- Conditions
- Asymptomatic Carotid Artery Stenosis
- Keywords
- Asymptomatic carotid stenosis, Carotid stenting, Best medical therapy, Randomized controlled trial, Stroke prevention, Endovascular treatment, Carotid artery disease, Ischemic stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 982 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 28 Mar 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 is a multicenter, prospective, open-label, endpoint-blinded, randomized controlled trial designed to evaluate the safety and efficacy of endovascular stenting combined with optimal medical therapy versus optimal medical therapy alone in patients with asymptomatic severe stenosis (70-99%) of the internal carotid artery. The study plans to enroll 982 patients aged 40-80 years who have had no ipsilateral carotid artery-related neurological symptoms in the past six months and who have declined carotid endarterectomy. The primary endpoints include stroke, myocardial infarction, or death within 30 days post-procedure/enrollment, as well as the incidence of ipsilateral stroke from 30 days to one year post-procedure/enrollment. Secondary endpoints include procedural success rate, restenosis rate, changes in cognitive function, and others. The study results will provide high-level evidence-based medical evidence for the treatment selection of patients with asymptomatic carotid artery stenosis.
Detailed description
This multicenter, prospective, open-label, randomized controlled trial with blinded endpoint assessment aims to evaluate the safety and efficacy of endovascular stenting combined with best medical therapy (BMT) versus BMT alone in patients with asymptomatic severe stenosis (70-99%) of the internal carotid artery (ICA). The study will enroll 982 participants aged 40-80 years who have no history of ipsilateral transient ischemic attack (TIA), stroke, or related neurological symptoms within the past 6 months and have declined carotid endarterectomy. The primary objective is to determine whether stenting reduces the composite risk of stroke, myocardial infarction, or death within 30 days post-procedure/enrollment, as well as ipsilateral stroke from 30 days to 1 year. Secondary objectives include assessing procedural success, restenosis rates, cognitive outcomes (measured by Montreal Cognitive Assessment [MoCA] and Mini-Mental State Examination [MMSE]), and long-term clinical outcomes.
The trial will be conducted across multiple centers in China, led by Beijing Tiantan Hospital, Capital Medical University. Participants will be randomly assigned (1:1) via a computer-generated stratified randomization scheme to either the intervention group (endovascular stenting plus BMT) or the control group (BMT alone). BMT includes antiplatelet therapy, lipid-lowering agents, blood pressure control, and management of other cardiocerebrovascular risk factors. Endpoint adjudication will be performed by an independent blinded clinical events committee to minimize bias.
Eligible participants must have severe ICA origin stenosis confirmed by ultrasound, computed tomography angiography (CTA), or digital subtraction angiography (DSA), with contralateral ICA stenosis <70%. Key exclusion criteria include recent symptomatic stenosis, intracranial hemorrhage within 1 year, severe cardiopulmonary comorbidities, contraindications to antiplatelet/anticoagulant therapy, life expectancy <5 years, or anatomical challenges (e.g., Type III aortic arch, severe vascular tortuosity/calcification). Imaging exclusions focus on technical feasibility and safety, such as tandem intracranial stenosis or distal lesions more severe than the target stenosis.
The primary endpoints are the 30-day composite rate of stroke, myocardial infarction, or death, and the incidence of ipsilateral stroke between 30 days and 1 year. Secondary endpoints include technical success (defined as residual stenosis <30% with Thrombolysis in Myocardial Infarction [TIMI] grade 3 flow post-procedure), 30-day and 12-month mortality, restenosis rates, and cognitive changes. Statistical analysis will follow the intention-to-treat principle, with Kaplan-Meier survival analysis and log-rank tests for primary outcomes. Cox proportional hazards models will estimate hazard ratios (HRs) with 95% confidence intervals (CIs). Sensitivity analyses will use per-protocol and as-treated populations.
The study duration is scheduled from August 2024 to July 2028, including a 12-month follow-up period. Ethical approval will be obtained from all participating centers, and the trial will adhere to the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal carotid artery stenting and medical treatment | Experimental | Procedure: Endovascular treatment |
| Best Medical Therapy | Active comparator | Drug: Best medical treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40-80 years
- Severe asymptomatic internal carotid artery stenosis (70-99%) confirmed by ultrasound/CTA/DSA
- Contralateral ICA stenosis <70%
- No TIA/stroke related to target lesion in past 6 months
- Declined carotid endarterectomy
Key exclusion criteria (30 listed)
- symptomatic internal carotid artery stenosis in the past 6 months
- Spontaneous intracranial hemorrhage in nearly one year
- Patients with larger intracranial aneurysms (diameter >5 mm) who cannot undergo prior or concurrent treatment
- Chronic occlusion without obvious symptoms of cerebral ischemic attack
- Patients with transient or permanent neurological deficit resulting from Neurological deficits mimicking TIA/stroke from TIA or stroke
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 |
|---|---|---|
| Endovascular treatmentParticipants will receive carotid artery stenting as the primary intervention. The procedure will be performed via femoral artery access (radial access allowed for anatomically challenging cases) with mandatory use of an embolic protection device (EPD). Stent selection and EPD type will be determined by the operator based on lesion characteristics. Pre-procedural dual antiplatelet therapy (DAPT: aspirin 100 mg/day + clopidogrel 75 mg/day) will be administered for ≥3-5 days. Post-procedural DAPT will continue for 3 months, transitioning to aspirin monotherapy (100 mg/day) thereafter. Statins and risk factor management (blood pressure、LDL-C, glycemic control) will align with standardized protocols. | Procedure or surgery | Internal carotid artery stenting and medical treatment |
| Best medical treatmentParticipants will receive intensive medical management, including aspirin (75-325 mg/day) or alternative antiplatelet agents (clopidogrel/dipyridamole) for intolerance. Statin therapy and risk factor control targets (blood pressure, lipids, glucose, lifestyle) will mirror the experimental group. Both groups will undergo regular follow-up for adherence monitoring. | Drug | Best Medical Therapy |
Primary outcome
Efficacy endpoint
Time frame: Within 30 days/ between 30 days and 12 months post-enrollment or post-procedure
The primary outcome was a composite of any stroke, myocardial infarction (MI), or all-cause mortality within 30 days post-enrollment or post-procedure, plus ipsilateral stroke between 30 days and 12 months post-enrollment/procedure.
13 secondary outcomes
Success rate of surgical technique
Time frame: Surgery completed
Incidence of myocardial infarction
Time frame: Within 30 days after surgery or within 30 days of enrollment
Incidence of ipsilateral stroke
Time frame: Within 30 days after surgery or within 30 days of enrollment
Incidence of bilateral stroke
Time frame: Within 30 days after surgery or within 30 days of enrollment
The incidence of all-cause death
Time frame: Within 30 days after surgery or within 30 days of enrollment
Cognitive function improvement (MoCA scale)
Time frame: Within 30 days after surgery or within 30 days of enrollment
Cognitive improvement (MMSE scale)
Time frame: 30 days after surgery or within 30 days of enrollment
Incidence of ipsilateral stroke
Time frame: 12 months after surgery or enrollment
The incidence of all-cause death
Time frame: 12 months after surgery or enrollment
Incidence of bilateral stroke
Time frame: 12 months after surgery or enrollment
Rate of internal carotid artery restenosis
Time frame: 12 months after surgery or enrollment
Cognitive function improvement (MoCA scale)
Time frame: 12 months after surgery or within 12 months of enrollment.
Improvement in cognitive function (MMSE scale)
Time frame: 12 months after surgery or enrollment
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 28 Mar 2025.
- 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.
Feng Gao, MD principal investigator
Beijing Tiantan Hospital
Zhongrong Miao, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular treatment and Best medical treatment in people with Asymptomatic Carotid Artery Stenosis, run by Beijing Tiantan Hospital 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 7 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 28 Mar 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 Dapeng Sun, MD (+8619520064886, sundp1990@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy endpoint (time frame: Within 30 days/ between 30 days and 12 months post-enrollment or post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2025.