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

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

Overview

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.

Interventions

• Procedure Endovascular Therapy Plus Best Medical Treatment
  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 thromb
• Drug Best Medical Treatment Alone
  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.

Primary outcome measures

• Proportion of Patients Achieving mRS 0-3 at 90 Days [Time frame: 90 days]

Secondary outcome measures (8)

• 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)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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.
• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Xuanwu Hospital — Beijing

Identifiers

NCT: NCT07046299 · BAOCHE3

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗