Acute Basilar Artery OcclusionNCT07333950
The Efficacy and Safety of Endovascular Therapy for Acute Ischemic Stroke Due to Large Core Infarction
A study testing Endovascular Recanalization Strategy and Best Medical Management in people with Acute Basilar Artery Occlusion and Endovascular Therapy, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This study assesses the efficacy and safety of endovascular therapy in patients with acute basilar artery occlusion with large core infarction within a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Basilar Artery Occlusion, Endovascular Therapy, Large Core Infarction
- What is being tested?
- Endovascular Recanalization Strategy and Best Medical Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Interventional
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age ranged from 18 to 80 years
- Acute ischemic stroke in posterior circulation, the time from stroke onset (or finally found normal) to randomization was within 24 hours
- Acute basilar artery occlusion confirmed by CTA,MRA,or DSA
- Posterior circulation large core infarction:NCCT or DWI showed pc-ASPECTS≤5, or Pons-Midbrain Index (PMI)≥3
- NIHSS score ≥10 before randomization
- Pre-stroke mRS of 0-2
- Each patient or their legal representative must provide written informed consent before enrolment
Who cannot join
- Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization
- Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging
- Known or highly suspected chronic occlusion of basilar artery
- History of contraindication for contrast medium (except mild rash)
- Current pregnant or breast-feeding
- Refractory hypertension (defined as systolic blood pressure>220 mmHg or diastolic blood pressure>110 mmHg) that cannot be controlled by drug treatment;
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- Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
- It is known that patients with dementia or mental illness cannot complete neurological function assessment and follow-up
- Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.)
- Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months
- Any other condition (in the opinion of the site investigator) that inappropriate to participate this study
- CTA/MRA/DSA confirmed occlusion of anterior and posterior circulation
- Central nervous system vasculitis has been diagnosed or clinically suspected
- Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR>1.7
- Blood glucose<2.7 or>22.2 mmol/L; Platelet count<50×109/L, glomerular filtration rate<30ml/min or serum creatinine ≥ 3 mg/dl
- Acute cerebral infarction occurred within 48 hours after cardio cerebral vascular intervention or major surgery (patients over 48 hours can be included in the group)
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
Feng Gao, MD, 13581936066, gaofengletter@sina.com
About this study
Official title: The Efficacy and Safety of Endovascular Therapy for Acute Ischemic Stroke Due to Large Core Infarction -- A Multicenter, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial
This study assesses the efficacy and safety of endovascular therapy in patients with acute basilar artery occlusion with large core infarction within a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial
Read the detailed description
This is a prospective, randomized, open-label, controlled trial designed to compare 90-day clinical outcomes between endovascular therapy (EVT) and best medical management (BMM) in patients with acute posterior circulation large vessel occlusion (LVO) and large core infarction. Eligible patients, aged 18 to 80 years presenting within 24 hours of symptom onset or last known well, must have imaging-confirmed acute basilar artery occlusion and large core infarction, defined as a pc-ASPECTS ≤5 or a Pons-midbrain-index (PMI) ≥ 3 on NCCT or DWI. Participants will be randomly assigned (1:1) to receive EVT or BMM. The primary outcome is functional independence at 90 days, assessed by the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-3. Secondary outcomes include the distribution of mRS scores at 90 days, 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH)
- Being tested
- Endovascular Recanalization Strategy, Best Medical Management
- Keywords
- Ischemic Stroke, Acute Basilar Artery Occlusion, Endovascular Therapy, Large Core Infarction
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Recanalization StrategyProcedure or surgery
The endovascular approach is selected by the treating neurointerventionalist based on angiographic findings, occlusion characteristics, and procedural feasibility. Permitted techniques include mechanical thrombectomy using stent retriever and/or aspiration-based methods. Adjunctive endovascular procedures, such as balloon angioplasty, stent placement, or intra-arterial thrombolysis, may be used when deemed necessary to achieve or maintain vessel patency. Angiographic reperfusion is assessed during the procedure, and treatment is terminated once adequate revascularization is obtained. Subsequent medical management is individualized according to stroke mechanism, procedural findings, and post-treatment imaging.
Best Medical ManagementDrug
Best medical management consists of comprehensive evidence-based medical therapy for acute ischemic stroke, encompassing acute supportive care, neurological and physiological monitoring, etiological evaluation, and secondary prevention strategies. Standard pharmacological treatments are administered as appropriate, together with risk factor modification and supportive care measures, in accordance with current guideline recommendations. Endovascular recanalization procedures are not included in this treatment strategy.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Treatment Group | Experimental | Participants randomized to the endovascular recanalization arm will receive endovascular treatment in addition to best medical management. The procedure aims to achieve recanalization of the occluded posterior circulation vessel using mechanical thrombectomy techniques, including stent retriever and/or aspiration-based approaches. When necessary, adjunctive endovascular measures may be performed as rescue therapy at the discretion of the treating neurointerventionalist. Receives: Procedure: Endovascular Recanalization Strategy |
| Best Medical Management Group | Other | Participants randomized to this arm will receive best medical management alone, consistent with current guideline recommendations for the acute and secondary prevention phases of ischemic stroke. No endovascular recanalization procedures are permitted after randomization. Receives: Drug: Best Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization
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±14 days after randomization
Secondary outcomes (9)
MRS score as an ordinal scale at 90 (±14) days after randomization
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±14 days after randomization
Rate of mRS 0-2 at 90 (±14) days after randomization
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±14 days after randomization
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization
The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Measured: 24 hours after randomization
NIHSS score at 7 days after randomization or discharge (whichever came first)
The National Institute of Health Stroke Scale（NIHSS） ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Measured: 7 days after randomization or at discharge
Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after randomization
EuroQol Five Dimensions (EQ-5D) 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±14 days after randomization
The proportion of Barthel Index ≥ 95 at 90 (± 14) days after randomization
The proportion of Barthel Index ≥ 95 at 90 (± 14) days after randomization.
Measured: 90±14 days after randomization
Basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA, MRA, DSA or TCD)
Basilar artery recanalization at 18-36 hours after randomization (confirmed by CTA, MRA, DSA or TCD).
Measured: 18-36 hours after randomization
Technical success rate, defined as successful recanalization of target vessels at the end of surgery (eTICI 2b-3)
Technical success rate, defined as successful recanalization of target vessels at the end of surgery (eTICI 2b-3).
Measured: At the end of the operation
The proportion of mRS 0-4 at 90 (± 14) days after randomization
The proportion of mRS 0-4 at 90 (± 14) days after randomization.
Measured: 90±14 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Basilar Artery 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
- 308 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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333950
- Sponsor's protocol ID
- HX-A-2025081
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No