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Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core

Sponsor: The First Affiliated Hospital of University of Science and Technology of China • ClinicalTrials.gov ID: NCT07672795

Registry updated: 2026-10-13

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Description

Acute basilar artery occlusion is associated with high mortality and severe disability. Previous randomized trials have demonstrated the benefit of endovascular therapy in selected patients with basilar artery occlusion; however, patients with large ischemic core, commonly defined by low posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS), remain underrepresented and the benefit-risk profile of endovascular therapy in this subgroup is uncertain. This prospective, multicenter, randomized, open-label, blinded-endpoint trial will evaluate the efficacy and safety of endovascular therapy plus best medical management compared with best medical management alone in patients with acute basilar artery occlusion within 24 hours from symptom onset or last known well and pc-ASPECTS \<7. Eligible participants will be randomized in a 1:1 ratio to receive endovascular therapy plus best medical management or best medical management alone. The primary outcome is favorable functional outcome, defined as a modified Rankin Scale score of 0 to 3 at 90 days.

Interventions

Endovascular Therapy (Procedure)
Endovascular therapy consists of mechanical thrombectomy using stent retriever, direct aspiration, or combined techniques with the goal of achieving rapid and effective reperfusion of the occluded basilar artery.
Best Medical Management (Other)
Best medical management includes intravenous thrombolysis when eligible, antithrombotic therapy, standard stroke unit care, management of vascular risk factors, blood pressure control, and supportive care according to current clinical guidelines.

Eligibility criteria

Inclusion Criteria 1. Clinical presentation or imaging findings consistent with posterior-circulation ischemic stroke. 2. Basilar artery occlusion confirmed by CT angiography (CTA), MR angiography (MRA), or digital subtraction angiography (DSA). 3. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥10 before randomization. 4. Age 18-85 years, inclusive. 5. Baseline noncontrast CT, CTA source images, or diffusion-weighted MRI (DWI) demonstrating at least one of the following: * Posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS) of 0-5; or * Pons-Midbrain Index (PMI) \>4. 6. Randomization within 24 hours of the estimated time of basilar artery occlusion. * The estimated time of basilar artery occlusion is defined as the sudden onset of stroke symptoms consistent with acute basilar artery occlusion. * For patients with wake-up stroke or an unknown time of symptom onset, the last known well (LKW) time will be used as the reference time; randomization must occur within 24 hours of LKW. 7. Written informed consent provided by the participant or their legally authorized representative. Exclusion Criteria 1. Prestroke modified Rankin Scale (mRS) score ≥3. 2. Pregnancy or breastfeeding. 3. Allergy to contrast agents or nickel-titanium alloy. 4. Current participation in another clinical trial. 5. Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg that cannot be controlled with antihypertensive treatment. 6. A hereditary or acquired bleeding diathesis, coagulation factor deficiency, or oral anticoagulant use with an international normalized ratio (INR) \>3.0. 7. Blood glucose \<50 mg/dL (2.8 mmol/L) or \>400 mg/dL (22.2 mmol/L), platelet count \<50 × 10⁹/L, or hematocrit \<25%. 8. Life expectancy \<1 year. 9. Inability to complete the 90-day follow-up, for example because of a lack of a fixed residence or residence overseas that prevents follow-up. 10. A documented history of cerebral vasculitis. 11. A pre-existing neurological or psychiatric disorder that would interfere with clinical assessment. Imaging-Based Exclusion Criteria 12. Intracranial hemorrhage on CT or MRI. Patients with cerebral microbleeds \<5 mm in diameter detected on MRI may be included. 13. Vascular tortuosity, anatomical variation, or arterial dissection on CTA, MRA, or DSA that would make endovascular treatment technically difficult. 14. An intracranial tumor, except for a small meningioma.

Conditions

Acute Ischemic Stroke Basilar Artery Occlusion Large Ischemic Core

Locations

The first affiliated hospital of USTC — Hefei, Anhui, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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