EVT in Acute Basilar Artery Occlusion With Large Infarction Core

Launched by THE FIRST AFFILIATED HOSPITAL OF HAINAN MEDICAL UNIVERSITY · Jul 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a serious type of stroke caused by a blockage in the basilar artery, which is an important blood vessel in the brainstem. The trial aims to find out if adding a procedure called endovascular treatment (EVT), where doctors use special tools to remove the blockage, along with the best medical care, helps patients more than just giving the best medical care alone. This study focuses on patients who have a large area of brain damage from the stroke but are still within 24 hours of when their symptoms started.

To join the study, patients need to be adults (18 years or older) who have signs of this specific type of stroke confirmed by brain scans, with a certain level of stroke severity. People with other serious health issues, recent brain bleeding, or those who cannot safely undergo the treatment won’t be able to participate. If selected, participants will receive either the standard medical treatment or the standard treatment plus the EVT procedure, and the researchers will carefully monitor their recovery and safety. The goal is to learn which approach works best to help people recover from this dangerous stroke.

Gender

ALL

Eligibility criteria

• 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).