Endovascular Therapy for Basilar Artery Occlusion With Large Ischemic Core

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, open-label study comparing endovascular therapy plus best medical management to best medical management alone in adults with acute basilar artery occlusion and a large ischemic core (pc-ASPECTS 0–6 or PMI >4). Participants must be treated within 24 hours of symptom onset or last known well and have a baseline NIHSS of 6 or higher. Randomization is 1:1 with stratification by center, NIHSS, and onset-to-treatment time; both groups may receive guideline-concordant intravenous thrombolysis. Primary outcome is favorable functional status (mRS 0–3) at 90 days; secondary outcomes include mRS 0–2, NIHSS/GCS changes, imaging results, quality of life, and safety endpoints including symptomatic intracranial hemorrhage.

Why it matters

Who can join: the full rules

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.

Where it's running

• The first affiliated hospital of USTC
  Hefei, Anhui, China Recruiting

Study contacts

• Principal investigator: Wei Hu, PhD — The First Affiliated Hospital of University of Science and Technology of China
• Study coordinator: Chunrong Tao, PhD
• Email: chunrongtao@126.com
• Phone: +8662284079

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.