Endovascular treatment for acute basilar artery stroke with a large infarct core

Trial of Endovascular Treatment in Acute Basilar Artery Occlusion Patients With a Large Infarct Core

This trial will test whether adding endovascular clot removal to standard medical care helps adults with acute basilar artery occlusion who already have a large area of brain damage.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 348 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Hainan Medical University (Government)
• Locations: 1 site (Haikou, Hainan)
• Trial ID: NCT07090941 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective, open-label, blinded-endpoint randomized controlled trial comparing best medical management (BMM) plus endovascular treatment (EVT) versus BMM alone. Adults with basilar or qualifying vertebral artery occlusion, NIHSS ≥10, and a large posterior-circulation infarct core meeting pc‑ASPECTS criteria within 24 hours of last known well are randomized 1:1 by a centralized simple randomization. Treating teams know the assigned therapy while outcomes are adjudicated blinded to reduce bias. The trial focuses on neurological outcomes and safety of adding EVT in this high-risk population.

Who should consider this trial

Good fit: Adults (≥18 years) with acute basilar or qualifying vertebral artery occlusion, NIHSS ≥10, pc‑ASPECTS 3–5 for those under 80 (or 3–7 for those 80 and older), within 24 hours of last known well, and able to provide consent or have a representative who can consent.

Not a fit: Patients with significant pre-stroke disability (pre-stroke mRS >2), anatomical or technical factors expected to prevent completion of endovascular therapy, or other trial exclusions are unlikely to receive benefit from the EVT arm.

Why it matters

Potential benefit: If successful, adding EVT to standard care could reduce disability and improve neurologic recovery for patients with basilar artery occlusion and large infarct cores.

How similar studies have performed: Endovascular therapy is well established for anterior-circulation large-vessel occlusions, but randomized evidence for EVT specifically in basilar artery occlusion with large infarct cores is limited and less proven.

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).

Where this trial is running

Haikou, Hainan

• First Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (Recruiting)

Study contacts

• Study coordinator: Zhengqiang Zhao, PhD

Conditions Basilar Artery Occlusion; Large Ischemic Core; Large Core Infarct; Endovascular Treatments; Endovascular treatment; Large infarct core