Basilar Artery Occlusion Chinese Endovascular Trial in Patients With Large Core Infarct (BAOCHE3)

Capital Medical University

Status: Not yet enrolling

Conditions: Basilar Artery Occlusion; Ischemic Stroke; Large Core Infarct

Treatments: Drug: Best Medical Treatment Alone; Procedure: Endovascular Therapy Plus Best Medical Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07046299

BAOCHE3

Details and patient eligibility

About

This study evaluates the safety and efficacy of endovascular therapy for acute basilar artery occlusion with large core infarcts in a multicenter randomized trial.

Full 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.

Enrollment: 314 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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314 participants in 2 patient groups

Endovascular Therapy Plus Best Medical Treatment

Experimental group

Description:

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.

Treatment:

Procedure: Endovascular Therapy Plus Best Medical Treatment

Best Medical Treatment Alone

Active Comparator group

Description:

Patients in this arm will receive best medical treatment alone in accordance with current stroke guidelines. No endovascular therapy will be performed.

Treatment:

Drug: Best Medical Treatment Alone