Intracranial Atherosclerotic Stenosis-Related Large Vessel OcclusionNCT07618052
Efficacy and Safety of Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Intracranial Atherosclerotic Large Vessel Occlusion (ANGEL-REBOOT 2)
A study testing Bailout Intracranial Angioplasty or Stenting and Standard Thrombectomy in people with Intracranial Atherosclerotic Stenosis-Related Large Vessel Occlusion and Acute Ischemic Stroke, run by Feng Gao at 1 site in China.
Trial summary
A multicenter, randomized, open-label, blinded-endpoint trial with a concurrent prospective observational cohort to compare bailout intracranial angioplasty or stenting versus standard therapy on functional outcome, stroke recurrence, and mortality in patients with acute intracranial atherosclerotic stenosis-related… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Atherosclerotic Stenosis-Related Large Vessel Occlusion, Acute Ischemic Stroke, Bailout Angioplasty or Stenting
- What is being tested?
- Bailout Intracranial Angioplasty or Stenting and Standard Thrombectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years.
- Time interval from symptom onset to puncture ≤24 hours.
- National Institute of Health Stroke Scale (NIHSS) Score ≥6 before randomisation.
- Pre-stroke modified Rankin Scale (mRS) of 0-2.
- Each patient or their legal representative must provide written informed consent before enrolment.
- Imaging Inclusion Criteria:
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- For patients with anterior circulation stroke, a CT or DWI-based Alberta Stroke Program Early CT Score (ASPECTS) of ≥6 is required.
- For patients with posterior circulation stroke, CT or DWI-based posterior circulation ASPECTS (pc-ASPECTS) of ≥6 and Pons-Midbrain Index (PMI) of <3 are required.
- Angiographic Inclusion Criteria:
- Acute ischemic stroke (AIS) resulting from large vessel occlusion (LVO) involving the intracranial internal carotid artery, the M1 segment of the middle cerebral artery, the V4 segment of the vertebral artery, or the basilar artery, with high suspicion of intracranial atherosclerotic stenosis-related large-vessel occlusion (ICAS-LVO).
- Part 1 (RCT): Successful recanalization of the occluded artery (eTICI ≥ 2b) with residual stenosis ≥ 70% after 1-2 thrombectomy attempts.
- Part 2 (Prospective observational cohort): Failure to achieve successful recanalization (eTICI 0-2a) after at least two thrombectomy attempts. All other inclusion criteria are identical to those for Part 1.
- Occluded artery amenable to angioplasty (balloon dilation and/or stenting) by the judgement of the treating neurointerventionalist.
Who cannot join
- Any sign of intracranial hemorrhage (ICH, except microbleeds) on baseline brain imaging.
- CT or MR imaging evidence of intracranial tumor (except small meningiomas or cerebral aneurysms < 3mm in diameter).
- Any indication of intracranial vessel perforation during thrombectomy..
- Presence of tandem lesion in the extracranial segment of the internal carotid artery or vertebral artery, or intracranial arterial stenosis with distal vessel occlusion..
- Stenosis caused by non-atherosclerotic intracranial arteriopathies (e.g., autoimmune vasculitis, vasospasm, cerebral artery dissection).
- Evidence of cardioembolism (e.g., atrial fibrillation, prosthetic heart valve, infective endocarditis, mitral stenosis, atrial myxoma, intracardiac thrombus/vegetation, left ventricular aneurysm, etc.).
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- Contraindication for antiplatelet treatment.
- Excessive vascular tortuosity or anatomical variants that may preclude successful delivery or positioning of interventional devices.
- History of contraindication to the use of contrast medium.
- Refractory hypertension (defined as systolic blood pressure>185 mmHg or diastolic blood pressure>110 mmHg) that cannot be controlled by drug treatment.
- Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR>1.5.
- Blood glucose<2.8 or>22.2 mmol/L; Platelet count<100*109/L, serum creatinine>2.0 g/L (177 μ mol/L), or glomerular filtration rate<30 ml/(min*1.73 m2).
- Concurrent participation in another drug or device trial, or expected participation within the following 3 months.
- Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.).
- Known pregnancy or lactation, or positive pregnancy test before randomization (or before enrollment).
- Known dementia or psychiatric disorder that precludes completion of neurological assessments and follow-up.
- Any other condition deemed by the site investigator to make the patient unsuitable for participation.
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
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: Efficacy and Safety of Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Intracranial Atherosclerotic Large Vessel Occlusion: A Clinical Trial Combining a Randomized Controlled Trial and a Concurrent Prospective Observational Cohort
A multicenter, randomized, open-label, blinded-endpoint trial with a concurrent prospective observational cohort to compare bailout intracranial angioplasty or stenting versus standard therapy on functional outcome, stroke recurrence, and mortality in patients with acute intracranial atherosclerotic stenosis-related large vessel occlusion after thrombectomy.
Read the detailed description
This is a clinical trial with a composite design, consisting of: (1) a multicenter, prospective, open-label, blinded-endpoint randomized controlled trial (RCT) for patients with successful recanalization but residual severe stenosis (>70%) after thrombectomy, and (2) a concurrent prospective observational cohort for patients with failed recanalization. Patients with acute ischemic stroke due to intracranial atherosclerotic stenosis-related large vessel occlusion (ICAS-LVO) within 24 hours of symptom onset who undergo up to two thrombectomy passes are assessed. Those achieving successful recanalization (expanded Thrombolysis in Cerebral Infarction [eTICI] grade ≥2b) but with residual stenosis ≥70% are enrolled in the RCT and randomly assigned in a 1:1 ratio to receive either bailout angioplasty or stenting (BAOS) (intervention group) or standard therapy (control group). Randomization is performed using a centralized interactive web response system with a minimization method, stratified by baseline National Institutes of Health Stroke Scale score (6-15 vs. ≥16), time from symptom onset to puncture (≤6 hours vs. 6-24 hours), and occlusion site (anterior circulation vs. posterior circulation). For patients who fail to achieve successful recanalization (eTICI 0-2a) after at least two thrombectomy passes, they are enrolled in the concurrent prospective observational cohort without randomization, and subsequent treatment (including continued thrombectomy, BAOS, or termination of the procedure) is at the discretion of the treating physician. The primary endpoint is the modified Rankin Scale (mRS) score at 90 days (±7 days) after randomization or enrollment. Key secondary efficacy endpoints include the proportion of patients with mRS scores of 0-1, 0-2, and 0-3 at 90 days; stroke recurrence in the target vessel territory within 90 days and 1 year; NIHSS score at 24 hours; and quality of life measures at 90 days and 1 year. Safety endpoints include symptomatic intracranial hemorrhage within 24 hours (defined by the Heidelberg Bleeding Classification), any intracranial hemorrhage within 24 hours, mortality at 7 days, 90 days, and 1 year, and procedure-related complications (e.g., arterial perforation, dissection, or distal embolization). Follow-up assessments are performed at 24 hours, 7 days or discharge (whichever occurs first), 90 days, and every 3 months thereafter until 1 year after randomization or enrollment.
- Conditions
- Intracranial Atherosclerotic Stenosis-Related Large Vessel Occlusion, Acute Ischemic Stroke, Bailout Angioplasty or Stenting
- Being tested
- Bailout Intracranial Angioplasty or Stenting, Standard Thrombectomy
- Keywords
- Acute Intracranial Atherosclerotic Stenosis-Related Large Vessel Occlusion, Endovascular Thrombectomy, Bailout Angioplasty or Stenting
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bailout Intracranial Angioplasty or StentingProcedure or surgery
Balloon angioplasty and/or stent placement for residual severe stenosis (≥70%) after successful thrombectomy; combined with medical management (intravenous tirofiban, followed by dual antiplatelet therapy with aspirin 100 mg/day and clopidogrel 75 mg/day for 90 days, then single antiplatelet therapy thereafter; and cerebrovascular risk factor management).
Standard ThrombectomyProcedure or surgery
Endovascular thrombectomy performed according to guideline recommendations, without additional endovascular intervention; combined with medical management (intravenous tirofiban as needed, dual antiplatelet therapy with aspirin 100 mg/day and clopidogrel 75 mg/day for 90 days, then single antiplatelet therapy thereafter; and cerebrovascular risk factor management).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Bailout Angioplasty or Stenting (BAOS) Group Receives: Procedure: Bailout Intracranial Angioplasty or Stenting |
| Control group | Other | Standard Ttherapy Group Receives: Procedure: Standard Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the mRS score at 90 (±7) days after randomization (or after enrollment), analyzed as an ordinal variable
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
Measured: 90±7 days after randomization (or after enrollment)
Secondary outcomes (10)
The proportion of mRS 0-1, 0-2 and 0-3 at 90 (±7) days
The proportion of mRS 0-1, 0-2 and 0-3 at 90 (±7) days.
Measured: 90±7 days after randomization (or after enrollment)
The rate of stroke recurrence in the target vessel territory within 90 (±7) days
Stroke recurrence in the target vessel territory within 90 (±7) days.
Measured: 90±7 days after randomization (or after enrollment)
NIHSS score at 24 (±6/+12) hours
The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Measured: 24 (-6/+12) hours after randomization (or after enrollment)
European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score at 90±7 days
EuroQol Five Dimensions (EQ-5D-5L) is a standardized instrument for measuring the general health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
Measured: 90±7 days after randomization (or after enrollment)
Patency of the target vessel at 24 (±6/+12) hours after the procedure, as confirmed by CTA, MRA, DSA, or TCD
Patency of the target vessel at 24 (±6/+12) hours after the procedure, as confirmed by CTA, MRA, DSA, or TCD.
Measured: 24 (-6/+12) hours after randomization (or after enrollment)
The mRS score at 1 year (±30 days), analyzed as an ordinal variable
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
Measured: 1 year (±30 days) after randomization (or after enrollment)
The proportion of mRS 0-1, 0-2 and 0-3 scores at 1 year (± 30 days)
The proportion of mRS 0-1, 0-2 and 0-3 scores at 1 year (± 30 days).
Measured: 1 year (±30 days) after randomization (or after enrollment)
The rate of stroke recurrence in the target vessel territory within 1 year (± 30 days)
Stroke recurrence in the target vessel territory within 1 year (± 30 days).
Measured: 1 year (±30 days) after randomization (or after enrollment)
Patency of the target vessel at 1 year (± 30 days) after the procedure, as confirmed by CTA, MRA, DSA, or TCD
Patency of the target vessel at 1 year (± 30 days) after the procedure, as confirmed by CTA, MRA, DSA, or TCD.
Measured: 1 year (±30 days) after randomization (or after enrollment)
European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score at 1 year (±30 days)
EuroQol Five Dimensions (EQ-5D-5L) is a standardized instrument for measuring the general health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
Measured: 1 year (±30 days) after randomization (or after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Atherosclerotic Stenosis-Related Large Vessel OcclusionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feng Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Gao, Beijing Tiantan Hospital
- Investigators
- Feng Gao, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618052
- Sponsor's protocol ID
- HX-A-2026023
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 1 Jun 2026
- 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Intracranial Atherosclerotic Large Vessel Occlusion: A Clinical Trial Combining a Randomized Controlled Trial and a Concurrent Prospective Observational Cohort
- ClinicalTrials.gov ID
- NCT07618052
- Acronym / sponsor ID
- HX-A-2026023
- Conditions
- Intracranial Atherosclerotic Stenosis-Related Large Vessel Occlusion, Acute Ischemic Stroke, Bailout Angioplasty or Stenting
- Keywords
- Acute Intracranial Atherosclerotic Stenosis-Related Large Vessel Occlusion, Endovascular Thrombectomy, Bailout Angioplasty or Stenting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Feng GaoUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 1 Jun 2026 (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.
A multicenter, randomized, open-label, blinded-endpoint trial with a concurrent prospective observational cohort to compare bailout intracranial angioplasty or stenting versus standard therapy on functional outcome, stroke recurrence, and mortality in patients with acute intracranial atherosclerotic stenosis-related large vessel occlusion after thrombectomy.
Detailed description
This is a clinical trial with a composite design, consisting of: (1) a multicenter, prospective, open-label, blinded-endpoint randomized controlled trial (RCT) for patients with successful recanalization but residual severe stenosis (>70%) after thrombectomy, and (2) a concurrent prospective observational cohort for patients with failed recanalization. Patients with acute ischemic stroke due to intracranial atherosclerotic stenosis-related large vessel occlusion (ICAS-LVO) within 24 hours of symptom onset who undergo up to two thrombectomy passes are assessed. Those achieving successful recanalization (expanded Thrombolysis in Cerebral Infarction [eTICI] grade ≥2b) but with residual stenosis ≥70% are enrolled in the RCT and randomly assigned in a 1:1 ratio to receive either bailout angioplasty or stenting (BAOS) (intervention group) or standard therapy (control group). Randomization is performed using a centralized interactive web response system with a minimization method, stratified by baseline National Institutes of Health Stroke Scale score (6-15 vs. ≥16), time from symptom onset to puncture (≤6 hours vs. 6-24 hours), and occlusion site (anterior circulation vs. posterior circulation). For patients who fail to achieve successful recanalization (eTICI 0-2a) after at least two thrombectomy passes, they are enrolled in the concurrent prospective observational cohort without randomization, and subsequent treatment (including continued thrombectomy, BAOS, or termination of the procedure) is at the discretion of the treating physician. The primary endpoint is the modified Rankin Scale (mRS) score at 90 days (±7 days) after randomization or enrollment. Key secondary efficacy endpoints include the proportion of patients with mRS scores of 0-1, 0-2, and 0-3 at 90 days; stroke recurrence in the target vessel territory within 90 days and 1 year; NIHSS score at 24 hours; and quality of life measures at 90 days and 1 year. Safety endpoints include symptomatic intracranial hemorrhage within 24 hours (defined by the Heidelberg Bleeding Classification), any intracranial hemorrhage within 24 hours, mortality at 7 days, 90 days, and 1 year, and procedure-related complications (e.g., arterial perforation, dissection, or distal embolization). Follow-up assessments are performed at 24 hours, 7 days or discharge (whichever occurs first), 90 days, and every 3 months thereafter until 1 year after randomization or enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Bailout Intracranial Angioplasty or StentingBailout Angioplasty or Stenting (BAOS) Group |
| Control group | Other | Procedure: Standard ThrombectomyStandard Ttherapy Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age≥18 years.
- Time interval from symptom onset to puncture ≤24 hours.
- National Institute of Health Stroke Scale (NIHSS) Score ≥6 before randomisation.
- Pre-stroke modified Rankin Scale (mRS) of 0-2.
- Each patient or their legal representative must provide written informed consent before enrolment.
Key exclusion criteria (17 listed)
- Any sign of intracranial hemorrhage (ICH, except microbleeds) on baseline brain imaging.
- CT or MR imaging evidence of intracranial tumor (except small meningiomas or cerebral aneurysms < 3mm in diameter).
- Any indication of intracranial vessel perforation during thrombectomy..
- Presence of tandem lesion in the extracranial segment of the internal carotid artery or vertebral artery, or intracranial arterial stenosis with distal vessel occlusion..
- Stenosis caused by non-atherosclerotic intracranial arteriopathies (e.g., autoimmune vasculitis, vasospasm, cerebral artery dissection).
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 |
|---|---|---|
| Bailout Intracranial Angioplasty or StentingBalloon angioplasty and/or stent placement for residual severe stenosis (≥70%) after successful thrombectomy; combined with medical management (intravenous tirofiban, followed by dual antiplatelet therapy with aspirin 100 mg/day and clopidogrel 75 mg/day for 90 days, then single antiplatelet therapy thereafter; and cerebrovascular risk factor management). | Procedure or surgery | Intervention group |
| Standard ThrombectomyEndovascular thrombectomy performed according to guideline recommendations, without additional endovascular intervention; combined with medical management (intravenous tirofiban as needed, dual antiplatelet therapy with aspirin 100 mg/day and clopidogrel 75 mg/day for 90 days, then single antiplatelet therapy thereafter; and cerebrovascular risk factor management). | Procedure or surgery | Control group |
Primary outcome
The primary endpoint is the mRS score at 90 (±7) days after randomization (or after enrollment), analyzed as an ordinal variable
Time frame: 90±7 days after randomization (or after enrollment)
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
10 secondary outcomes
The proportion of mRS 0-1, 0-2 and 0-3 at 90 (±7) days
Time frame: 90±7 days after randomization (or after enrollment)
The rate of stroke recurrence in the target vessel territory within 90 (±7) days
Time frame: 90±7 days after randomization (or after enrollment)
NIHSS score at 24 (±6/+12) hours
Time frame: 24 (-6/+12) hours after randomization (or after enrollment)
European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score at 90±7 days
Time frame: 90±7 days after randomization (or after enrollment)
Patency of the target vessel at 24 (±6/+12) hours after the procedure, as confirmed by CTA, MRA, DSA, or TCD
Time frame: 24 (-6/+12) hours after randomization (or after enrollment)
The mRS score at 1 year (±30 days), analyzed as an ordinal variable
Time frame: 1 year (±30 days) after randomization (or after enrollment)
The proportion of mRS 0-1, 0-2 and 0-3 scores at 1 year (± 30 days)
Time frame: 1 year (±30 days) after randomization (or after enrollment)
The rate of stroke recurrence in the target vessel territory within 1 year (± 30 days)
Time frame: 1 year (±30 days) after randomization (or after enrollment)
Patency of the target vessel at 1 year (± 30 days) after the procedure, as confirmed by CTA, MRA, DSA, or TCD
Time frame: 1 year (±30 days) after randomization (or after enrollment)
European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score at 1 year (±30 days)
Time frame: 1 year (±30 days) after randomization (or after 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 1 Jun 2026.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bailout Intracranial Angioplasty or Stenting and Standard Thrombectomy in people with Intracranial Atherosclerotic Stenosis-Related Large Vessel Occlusion and Acute Ischemic Stroke, run by Feng Gao 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 13 inclusion and 17 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 1 Jun 2026. 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 Feng Gao, MD (13581936066, gaofengletter@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the mRS score at 90 (±7) days after randomization (or after enrollment), analyzed as an ordinal variable (time frame: 90±7 days after randomization (or after enrollment)). 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 1 Jun 2026.