Tests catheter treatment for blocked basilar artery stroke with large core damage
Tests a catheter procedure plus medical care in adults with blocked basilar artery stroke.
Key facts
- Who runs it
- Capital Medical University
- Where
- Beijing, ChinaSee the site
- Trial code
- Registry title
- Basilar Artery Occlusion Chinese Endovascular Trial in Patients With Large Core Infarct
- Status
- Not yet recruiting
- People taking part
- 314 people, planned
- Started
- 1 Jul 2025
- Expected to end
- 30 Nov 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Endovascular Therapy Plus Best Medical Treatment
- Best Medical Treatment Alone
- Record updated
- 1 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 who have had a sudden stroke at the back of the brain within 24 hours. A blocked basilar artery has caused a large area of damaged brain tissue.
- Age
- 18 to 80 years
- Sex
- Women and men can join.
- Disease stage
- Acute stroke in the back of the brain within 24 hours of symptom onset or last seen well. The basilar artery or both vertebral arteries (V4) are blocked. Large core infarct: pc-ASPECTS score of 3-5 on imaging. Baseline NIHSS score of 6 or more.
Main reasons for not taking part
- Bleeding in the brain on CT or MRI
- Serious illness with life expectancy of less than one year
- Pregnant or breastfeeding, or positive pregnancy test
- Bleeding disorder, or platelet count below 50000/µL
- Pons-midbrain-index of 4 or more on imaging
The registry criteria, word for word
Show all 30 criteriaShow less
Who can take part
- 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 take part
- Patients in whom baseline NIHSS can not be obtained by a neurologist or emergency physician prior to sedation or intubation
- Subject participating in a study involving an investigational drug or device that would impact this study
- 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
- 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
- Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
- CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed)
- 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
- Renal insufficiency with creatinine ≥ 3 mg/dL
- Clinical exclusion criteria:
- Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission
- Known diagnosis or clinical suspicion of cerebral vasculitis
- 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
- 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)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- Xuanwu HospitalBeijing, ChinaContact: Chuanhui LiNo longer taking part
About the trial
What the trial wants to find out
This study evaluates the safety and efficacy of endovascular therapy for acute basilar artery occlusion with large core infarcts in a multicenter randomized trial.
The 2 groups in the trial
- Endovascular Therapy Plus Best Medical TreatmentTreatment being tested
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.
- Best Medical Treatment AloneExisting treatment, for comparison
Patients in this arm will receive best medical treatment alone in accordance with current stroke guidelines. No endovascular therapy will be performed.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Tests catheter treatment for blocked basilar artery stroke with large core damageGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07046299, who can take part
- Record updated
- 1 July 2025