Basilar Artery Occlusion Chinese Endovascular Trial
China217 participantsStarted 2016-07
Plain-language summary
Endovascular treatment of acute ischemic stroke has shown strong benefit in several prospective randomized trials in the anterior circulation and endovascular therapy for basilar artery occlusion has shown promising results in several single-arm studies. This has led to a broad adoption of these techniques which are now considered standard of care in many institutions despite the lack of adequate evidence to prove their benefit. Indeed, the rates of symptomatic intracerebral hemorrhage in these studies have consistently been around 5% which raises the question as to whether patients could actually be harmed as opposed to helped by these procedures. This is a prospective, multi-center, randomized, controlled, open, blinded-endpoint trial, with the aim to evaluate the hypothesis that mechanical embolectomy with the Solitaire device is superior to medical management alone in achieving better outcomes in subjects presenting with an acute ischemic stroke caused by occlusion of the basilar artery within 6-24 hours from symptom onset.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Posterior circulation AIS within 6-24 hours from symptom onset/last seen well where patient is ineligible for i.v. thrombolytic treatment, or patient has received i.v. thrombolytic therapy without recanalization.
✓. Occlusion (Thrombolysis in Myocardial Infarction, TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries as evidenced by computed tomography (CT) angiography, magnetic resonance (MR) angiography or angiogram.
✓. Age ≥18 and ≤80 years.
✓. Baseline National Institutes of Health Stroke Scale (NIHSS) score obtained prior to randomization must be equal to or higher than 6 points.
. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with international normalized ratio \> 3.0.
✕. Baseline platelet count \< 50.000/µL.
✕. Baseline blood glucose \< 50mg/dL or \> 400mg/dL.
✕. Severe, sustained hypertension (systolic blood pressure \> 220 mm Hg or diastolic blood pressure \> 110 mm Hg).
✕. Patients in sedation and/or intubated patients could not be included if baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation.
✕. Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
✕. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
✕. History of life threatening allergy (more than rash) to contrast medium