Basilar Artery OcclusionBAOCHE3NCT07046299
Basilar Artery Occlusion Chinese Endovascular Trial in Patients With Large Core Infarct
A study testing Endovascular Therapy Plus Best Medical Treatment and Best Medical Treatment Alone in people with Basilar Artery Occlusion and Ischemic Stroke, run by Capital Medical University at 1 site in China.
Trial summary
This study evaluates the safety and efficacy of endovascular therapy for acute basilar artery occlusion with large core infarcts in a multicenter randomized trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Basilar Artery Occlusion, Ischemic Stroke, Large Core Infarct
- What is being tested?
- Endovascular Therapy Plus Best Medical Treatment and Best Medical Treatment Alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 Nov 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Posterior circulation acute ischemic stroke within 24 hours from symptom onset/last seen well.
- Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
- Patients with large core infarction in the posterior circulation, defined as a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) score of 3-5 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT.
- Age ≥18 and ≤80 years.
- Baseline NIHSS score ≥6 at the time of randomization.
- No significant pre-stroke functional disability (modified Rankin Scale, mRS ≤ 1).
- Informed consent obtained from patient or acceptable patient surrogate.
Who cannot join
- Clinical exclusion criteria:
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0.
- Baseline platelet count < 50000/µL.
- Baseline blood glucose of < 50mg/dL or >400mg/dL.
- Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained below these levels using commonly used medications in China for these purposes (including iv antihypertensive drips), the patient can be enrolled.
- Patients in whom baseline NIHSS can not be obtained by a neurologist or emergency physician prior to sedation or intubation.
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- Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
- Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
- History of life threatening allergy (more than rash) to contrast medium.
- Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery .
- Renal insufficiency with creatinine ≥ 3 mg/dL.
- Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
- Subject participating in a study involving an investigational drug or device that would impact this study.
- Known diagnosis or clinical suspicion of cerebral vasculitis.
- Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
- Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
- Neuroimaging exclusion criteria:
- Pons-midbrain-index of ≥ 4 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT.
- CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).
- Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the fourth ventricle.
- Complete bilateral thalamic infarction on CT or MRI.
- Evidence of vertebral occlusion, high grade stenosis or arterial dissection in the extracranial or intracranial segment that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment.
- Subjects with occlusions in both anterior and posterior circulation.
- Evidence of intracranial tumor (except small meningioma).
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
Xuanwu Hospital
Beijing, Beijing Municipality, 100053
Chuanhui Li, +8615210439828, lichuanhui365@163.com
Xunming Ji, 01083198962, jixm@ccmu.edu.cn
About this study
Official title: Safety and Efficacy of Endovascular Therapy for Acute Basilar Artery Occlusion With Large Core Infarct: A Prospective, Multicenter, Randomized, Open-Label Controlled Trial
This study evaluates the safety and efficacy of endovascular therapy for acute basilar artery occlusion with large core infarcts in a multicenter randomized trial.
Read the detailed description
This is a prospective, randomized, open-label, controlled trial evaluating endovascular therapy (EVT) for patients with acute basilar artery occlusion (BAO) and large core infarcts, defined by a pc-ASPECTS score of 3-5 on DWI or CT. Eligible participants aged 18-80 years and presenting within 24 hours of symptom onset will be randomly assigned in a 1:1 ratio to receive either EVT plus standard medical therapy or medical therapy alone. Randomization will be stratified by age, baseline NIHSS, and onset-to-treatment time. The primary outcome is the proportion of patients achieving functional independence (mRS 0-3) at 90 days. Secondary outcomes include neurological improvement, mRS distribution, quality of life, and 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH). This study aims to generate high-quality evidence to guide treatment strategies for patients with acute basilar artery occlusion and large core infarcts.
- Being tested
- Endovascular Therapy Plus Best Medical Treatment, Best Medical Treatment Alone
- Keywords
- Endovascular Therapy, Large Core Infarct, Randomized Controlled Trial
- 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 Therapy Plus Best Medical TreatmentProcedure or surgery
Also called Mechanical Thrombectomy
Participants assigned to the endovascular therapy arm will receive EVT in addition to best medical treatment. EVT must be initiated within 24 hours of symptom onset and completed within 3 hours of groin puncture. After evaluating vascular anatomy, neurointerventionalists will determine the most appropriate strategy based on the presence of proximal stenosis, occlusion morphology, and vessel tortuosity. Permitted interventions include mechanical thrombectomy, stent thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, and stent implantation. The choice of treatment approach is left to the discretion of the treating physician, and combinations of techniques are allowed.
Best Medical Treatment AloneDrug
Participants in this arm will receive best medical treatment and maximal supportive care according to current stroke guidelines, without the use of mechanical thrombectomy or any intra-arterial intervention.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Therapy Plus Best Medical Treatment | Experimental | Patients randomized to this arm will receive endovascular therapy (EVT) in addition to best medical treatment. EVT must be initiated within 24 hours of symptom onset and completed within 3 hours.The EVT strategy will be selected by the treating neurointerventionalist based on vascular findings. Allowed procedures include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, or a combination of these. Receives: Procedure: Endovascular Therapy Plus Best Medical Treatment |
| Best Medical Treatment Alone | Active comparator | Patients in this arm will receive best medical treatment alone in accordance with current stroke guidelines. No endovascular therapy will be performed. Receives: Drug: Best Medical Treatment Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Achieving mRS 0-3 at 90 Days
The modified Rankin scale (range, 0 [no symptoms] to 6 [death]). Higher scores mean a worse outcome.
Measured: 90 days
Secondary outcomes (8)
Dramatic early favorable response
Dramatic early favorable response as determined by an National Institute of Health stroke scale (NIHSS) of 0-2 or NIHSS improvement ≥ 8 points at 24 (-2/+12) hours.
Measured: 24 (-2/+12) hours
Ordinal Shift analysis of mRS at 90 days
The modified Rankin scale (range, 0 [no symptoms] to 6 [death])
Measured: 90 days
Dichotomized mRS score (0-2 versus 3-6 )
The modified Rankin scale (range, 0 [no symptoms] to 6 [death])
Measured: 90 days
Proportion of Patients Achieving mRS 0-4 at 90 Days
The modified Rankin scale (range, 0 [no symptoms] to 6 [death])
Measured: 90 days
Barthel Index
The Barthel Index ranges from a minimum of 0 to a maximum of 100, with higher scores indicating better outcomes.
Measured: 90 days
Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 6 months
The modified Rankin scale (range, 0 [no symptoms] to 6 [death])
Measured: 6 months
Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 12 months
The modified Rankin scale (range, 0 [no symptoms] to 6 [death])
Measured: 12 months
Proportion of basilar artery recanalization
Vessel recanalization at 24 hours (-2/+12 hours) in both treatment groups assessed by using Arterial Occlusive Lesion (AOL) grades
Measured: 24 hours (-2/+12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046299
- Sponsor's protocol ID
- BAOCHE3
- Acronym
- BAOCHE3
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is proceeding.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endovascular Therapy for Acute Basilar Artery Occlusion With Large Core Infarct: A Prospective, Multicenter, Randomized, Open-Label Controlled Trial
- ClinicalTrials.gov ID
- NCT07046299
- Acronym / sponsor ID
- BAOCHE3 / BAOCHE3
- Keywords
- Endovascular Therapy, Large Core Infarct, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 1 Jul 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 evaluates the safety and efficacy of endovascular therapy for acute basilar artery occlusion with large core infarcts in a multicenter randomized trial.
Detailed description
This is a prospective, randomized, open-label, controlled trial evaluating endovascular therapy (EVT) for patients with acute basilar artery occlusion (BAO) and large core infarcts, defined by a pc-ASPECTS score of 3-5 on DWI or CT. Eligible participants aged 18-80 years and presenting within 24 hours of symptom onset will be randomly assigned in a 1:1 ratio to receive either EVT plus standard medical therapy or medical therapy alone. Randomization will be stratified by age, baseline NIHSS, and onset-to-treatment time. The primary outcome is the proportion of patients achieving functional independence (mRS 0-3) at 90 days. Secondary outcomes include neurological improvement, mRS distribution, quality of life, and 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH). This study aims to generate high-quality evidence to guide treatment strategies for patients with acute basilar artery occlusion and large core infarcts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Therapy Plus Best Medical Treatment | Experimental | Procedure: Endovascular Therapy Plus Best Medical TreatmentPatients randomized to this arm will receive endovascular therapy (EVT) in addition to best medical treatment. EVT must be initiated within 24 hours of symptom onset and completed within 3 hours.The EVT strategy will be selected by the treating neurointerventionalist based on vascular findings. Allowed procedures include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, or a combination of these. |
| Best Medical Treatment Alone | Active comparator | Drug: Best Medical Treatment AlonePatients in this arm will receive best medical treatment alone in accordance with current stroke guidelines. No endovascular therapy will be performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Posterior circulation acute ischemic stroke within 24 hours from symptom onset/last seen well.
- Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
- Patients with large core infarction in the posterior circulation, defined as a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) score of 3-5 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT.
- Age ≥18 and ≤80 years.
- Baseline NIHSS score ≥6 at the time of randomization.
Key exclusion criteria (24 listed)
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0.
- Baseline platelet count < 50000/µL.
- Baseline blood glucose of < 50mg/dL or >400mg/dL.
- Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained below these levels using commonly used medications in China for these purposes (including iv antihypertensive drips), the patient can be enrolled.
- Patients in whom baseline NIHSS can not be obtained by a neurologist or emergency physician prior to sedation or intubation.
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 Therapy Plus Best Medical TreatmentAlso: Mechanical ThrombectomyParticipants assigned to the endovascular therapy arm will receive EVT in addition to best medical treatment. EVT must be initiated within 24 hours of symptom onset and completed within 3 hours of groin puncture. After evaluating vascular anatomy, neurointerventionalists will determine the most appropriate strategy based on the presence of proximal stenosis, occlusion morphology, and vessel tortuosity. Permitted interventions include mechanical thrombectomy, stent thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, and stent implantation. The choice of treatment approach is left to the discretion of the treating physician, and combinations of techniques are allowed. | Procedure or surgery | Endovascular Therapy Plus Best Medical Treatment |
| Best Medical Treatment AloneParticipants in this arm will receive best medical treatment and maximal supportive care according to current stroke guidelines, without the use of mechanical thrombectomy or any intra-arterial intervention. | Drug | Best Medical Treatment Alone |
Primary outcome
Proportion of Patients Achieving mRS 0-3 at 90 Days
Time frame: 90 days
The modified Rankin scale (range, 0 [no symptoms] to 6 [death]). Higher scores mean a worse outcome.
8 secondary outcomes
Dramatic early favorable response
Time frame: 24 (-2/+12) hours
Ordinal Shift analysis of mRS at 90 days
Time frame: 90 days
Dichotomized mRS score (0-2 versus 3-6 )
Time frame: 90 days
Proportion of Patients Achieving mRS 0-4 at 90 Days
Time frame: 90 days
Barthel Index
Time frame: 90 days
Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 6 months
Time frame: 6 months
Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 12 months
Time frame: 12 months
Proportion of basilar artery recanalization
Time frame: 24 hours (-2/+12 hours)
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 Jul 2025.
- Individual participant dataSharing planned: No. The study is proceeding.
Related trials for Basilar Artery Occlusion
Active, not recruiting
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
Acute Ischemic Stroke, Basilar Artery Occlusion
Recruiting
Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core
Acute Ischemic Stroke, Basilar Artery Occlusion
Recruiting
Rescue Endovascular Treatment After Neurological Deterioration in Initially Mild Basilar Artery Occlusion in an Extended Time Window
Acute Mild Ischemic Stroke, Basilar Artery Occlusion
Recruiting
EVT in Acute Basilar Artery Occlusion With Large Infarction Core
Basilar Artery Occlusion, Large Ischemic Core
RecruitingObservational study
Basilar Artery Occlusion Chinese Endovascular Registry in Patients With Large-Core Infarct
Basilar Artery Occlusion, Ischemic Stroke
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.
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 Therapy Plus Best Medical Treatment and Best Medical Treatment Alone in people with Basilar Artery Occlusion and Ischemic Stroke, run by Capital Medical University 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 24 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 Jul 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 Xunming Ji (01083198962, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Achieving mRS 0-3 at 90 Days (time frame: 90 days). 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 Jul 2025.