Basilar Artery Occlusion Chinese Endovascular Trial in Patients With Large Core Infarct

Launched by CAPITAL MEDICAL UNIVERSITY · Jun 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called endovascular therapy for people who have had a specific type of stroke called basilar artery occlusion, which affects blood flow to important parts of the brain. The trial is focused on patients who have a large area of brain damage from this stroke and aims to see if this treatment is safe and helpful in improving their outcomes. The study will take place at multiple medical centers, but it has not started enrolling patients yet.

People who might be eligible for this trial are adults between 18 and 80 years old who have had a stroke in the back part of their brain within the last 24 hours. To join, they need to have a blockage in certain arteries at the base of the brain confirmed by imaging tests, and a moderate to severe stroke with some preserved brain function before the stroke happened. Participants will be carefully screened to ensure they don’t have conditions that could make the treatment risky, like bleeding problems, very high blood pressure, or other serious illnesses. If accepted, patients will receive the endovascular treatment and be closely monitored to see how well it works and if there are any side effects. The study will follow participants for 90 days to check their recovery progress.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Posterior circulation acute ischemic stroke within 24 hours from symptom onset/last seen well.
• • 2. Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
• • 3. 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.
• • 4. Age ≥18 and ≤80 years.
• • 5. Baseline NIHSS score ≥6 at the time of randomization.
• • 6. No significant pre-stroke functional disability (modified Rankin Scale, mRS ≤ 1).
• • 7. Informed consent obtained from patient or acceptable patient surrogate.
• Exclusion Criteria:
• Clinical exclusion criteria:
• • 1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0.
• • 2. Baseline platelet count \< 50000/µL.
• • 3. Baseline blood glucose of \< 50mg/dL or \>400mg/dL.
• • 4. 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.
• • 5. Patients in whom baseline NIHSS can not be obtained by a neurologist or emergency physician prior to sedation or intubation.
• • 6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
• • 7. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
• • 8. History of life threatening allergy (more than rash) to contrast medium.
• • 9. Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery .
• • 10. Renal insufficiency with creatinine ≥ 3 mg/dL.
• • 11. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
• • 12. Subject participating in a study involving an investigational drug or device that would impact this study.
• • 13. Known diagnosis or clinical suspicion of cerebral vasculitis.
• • 14. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
• • 15. Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
• Neuroimaging exclusion criteria:
• • 16. Pons-midbrain-index of ≥ 4 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT.
• • 17. CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).
• • 18. Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the fourth ventricle.
• • 19. Complete bilateral thalamic infarction on CT or MRI.
• • 20. 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.
• • 21. Subjects with occlusions in both anterior and posterior circulation.
• • 22. Evidence of intracranial tumor (except small meningioma).