The primary objective is to investigate whether treatment with Adacolumn can ameliorate the progression of cerebral edema within 72 hours in patients with anterior circulation ischemic stroke. The secondary objective is to explore if Adacolumn could improve acute neurologic status, functional outcomes, treatment requirements and safety in patients with anterior circulation ischemic stroke.
Age 18-80 years, regardless of gender;
A clinical diagnosis of acute ischemic stroke;
Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA or DSA;
NIHSS score ≥10 at screening;
Decompressive craniectomy performed before enrollment or between enrollment and initiation of study treatment;
After endovascular thrombectomy: extensive contrast extravasation (diffuse subarachnoid high density or parenchymal high density not consistent with hematoma), new subarachnoid hemorrhage（SAH）, or symptomatic intracranial hemorrhage (sICH);
Large-vessel occlusion is attributed to other determined etiologies per TOAST classification, such as tumor-related, dissection-related, or other clearly identifiable non-LAA/non-CE causes.
Clinical signs of brain herniation, such as unilateral or bilateral fixed dilated pupils and/or other loss of brainstem reflexes attributable to cerebral edema or herniation in the investigator's opinion;
Parallel
Adacolumn®
DeviceAdacolumn treatment ：once a day for 4 consecutive days after enrollment (60 minutes each time, blood flow rate 30 mL/min, total blood volume processed 1800 mL); the treatment was performed by establishing extracorporeal circulation through bilateral arm veins, and a total of 4 adsorption treatments were completed.
Standard Reperfusion Therapy
Procedure/SurgeryEndovascular thrombectomy and/or intravenous thrombolysis will be performed in strict accordance with the indications, contraindications, and operational specifications outlined in the Chinese Stroke Society Guidelines for Reperfusion Therapy in Acute Ischemic Stroke (2024) and the latest official prescribing information for the relevant pharmaceuticals.
Standard Medical Management
DrugStandard medical management for ischemic stroke.
The change in net water uptake (NWU) on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion
The change in net water uptake (NWU) measured on CT at 72-78 hours post-reperfusion, compared to the immediate post-reperfusion CT
Serious adverse events (SAEs) related to Adacolumn treatment (Primary Safety Outcome)
Adacolumn treatment-related SAEs specifically including but not limited to: hypotension requiring vasopressor support (systolic blood pressure \<90 mmHg); access site hemorrhage or hematoma; infection (manifested as fever or access site erythema); electrolyte disturbances such as hypokalemia or hypocalcemia; thrombocytopenia (platelet count \<100 × 10⁹/L); and any other event judged by the investigator to be a treatment-related SAE.
The number of discontinuation of Adacolumn therapy due to adverse events (Safety Outcome)
Record the number of patients who permanently discontinued Adacolumn therapy during the treatment period specifically due to SAEs
The change in midline shift on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion
Change in National Institutes of Health Stroke Scale (NIHSS) score on day 7 post-treatment compared to immediate post-operative baseline
Dynamic changes in peripheral blood immune cells before and after Adacolumn therapy
Cerebral immune cell infiltration analysis
For patients undergoing decompressive craniectomy combined with internal decompression, intraoperative brain tissue samples will be collected from the infarct region. These specimens will be subjected to comprehensive analysis to characterize the infiltration, including quantification, phenotypic identification, and functional assessment of immune cells
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