Recruiting
Not applicable
EVT in Acute Basilar Artery Occlusion With Large Infarction Core
Condition(s) studied
Basilar Artery OcclusionLarge Ischemic CoreLarge Core InfarctEndovascular Treatments
Investigational drug(s) / intervention(s)
Endovascular Treatment
Endovascular Treatment: The vascular access route is selected based on the patient's anatomical characteristics and operator discretion. Endovascular treatment (EVT) procedures must adhere to each participating center's standardized operating protocols. Upon confirmation of vascular occlusion, EVT may be performed using devices approved by China's National Medical Products Administration (NMPA). Based on lesion-specific features and operator judgment, permissible techniques include stent retriever thrombectomy, aspiration thrombectomy, balloon angioplasty with or without stenting, or intra-arterial thrombolysis. Investigational devices are strictly prohibited.
Study summary
A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the efficacy and safety of best medical management (BMM) combined with endovascular treatment (EVT) versus BMM alone in acute basilar artery occlusion (BAO) patients with large infarct cores.
Eligibility
Inclusion Criteria:
* 1\. Age ≥18 years. 2. Symptoms and signs consistent with basilar artery ischemia. 3. Basilar artery or vertebral artery occlusion confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), digital subtraction angiography (DSA); if vertebral artery occlusion is present, it must completely obstruct blood flow to the basilar artery.
4\. POST-NIHSS score ≥10 at randomization. 5. Time from symptom onset to randomization ≤24 hours (symptom onset defined as last known well time).
6\. pc-ASPECTS of 3-5 on CT/MRI (for patients aged \<80 years) or pc-ASPECTS of 3-7 (for patients aged ≥80 years).
7\. Willingness of the patient or legally authorized representative to comply with protocol requirements and data collection procedures, with documented informed consent.
Exclusion Criteria:
* 1\. Pre-stroke modified Rankin Scale (mRS) score \>2. 2. Factors in the target vessel that are expected to prevent completion of endovascular treatment.
3\. Concurrent anterior and posterior circulation strokes or multivessel occlusions.
4\. Significant mass effect with imaging or clinical signs of obstructive hydrocephalus or tonsillar herniation.
5\. Basilar artery occlusion confirmed as chronic by prior imaging or investigator judgment.
6\. Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations.
7\. Intracranial hemorrhage within the past 6 months, including parenchymal brain hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.
8\. Presence of active bleeding, coagulation disorders, or uncorrectable bleeding tendencies.
9\. Severe heart, liver, or kidney dysfunction or other severe systemic late-stage diseases.
10\. Known allergy to iodine contrast agents or other treatment-related drugs. 11. Medically uncontrolled refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) (Note: Participants can be included if their blood pressure is controllable with medication and maintained at an acceptable level).
12\. Uncontrollable blood glucose \<2.8 mmol/L or \>22.2 mmol/L. 13. Pregnancy or breastfeeding. 14. Life expectancy \<6 months. 15. Participation in other clinical studies that may affect outcome assessment. 16. Investigator's judgment that the patient is unsuitable for participation in this study or may face significant risks (e.g., due to mental illness, cognitive, or emotional disorders preventing understanding and/or compliance with study procedures and/or follow-up).
Primary outcome measure(s)
- Shift analysis of the improvement trend in modified Rankin Scale (mRS) scores at 90 (±7) days after randomization. — 90 (±7) days after randomization
Shift analysis is a statistical method used to evaluate the overall distribution change in modified Rankin Scale (mRS) scores, assessing whether an intervention leads to a general shift toward better outcomes across all score categories.
Trial sites (2)
| Facility | City | Region | Status |
|---|
| The First Affiliated Hospital of the University of Science and Technology of China |
Hefei |
Anhui |
Recruiting |
| First Affiliated Hospital of Hainan Medical University |
Haikou |
Hainan |
Recruiting |
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