[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622641":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":37,"locations":47,"responsibleParty":63,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":26,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Device: Adacolumn®","EXPERIMENTAL","Adacolumn Treatment Combined with Endovascular Thrombectomy and Standard Medical Therapy",[9,13,14],"Procedure: Endovascular Thrombectomy","Drug: Standard medical management",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Treatment","ACTIVE_COMPARATOR","Endovascular Thrombectomy and Standard Medical Therapy",[13,14],[21,27,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Adacolumn®","Adacolumn treatment ：once a day for 4 consecutive days after enrollment (60 minutes each time, blood flow rate 30 mL\u002Fmin, 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.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Endovascular Thrombectomy","Endovascular thrombectomy 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), as well as the latest official instructions for use of the relevant endovascular devices and adjunctive medications.",[9,16],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":26},"DRUG","Standard medical management","Standard medical management for ischemic stroke.",[9,16],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Jianmin Zhang","CONTACT","+86 13805722695","zjm135@zju.edu.cn",{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},"Ligen Shi","+86 13732233245","slg0904@zju.edu.cn",[48],{"facility":49,"status":26,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"The Second Affiliated Hospital of Zhejiang University School of Medicine","Hangzhou","Zhejiang","311221","China","CN",{"type":56,"coordinates":57},"Point",[58,59],120.16142,30.29365,{"lat":59,"lon":58},[62],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},{"type":64,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100622641","a-trial-of-adacolumn-on-cerebral-edema-after-anterior-circulation-ischemic-stroke-100622641",false,"NCT07386262","A Trial of Adacolumn on Cerebral Edema After Anterior Circulation Ischemic Stroke","Efficacy and Safety of the Adacolumn® Granulocyte and Monocyte\u002FMacrophage Apheresis Device for Cerebral Edema After Acute Anterior Circulation Occlusive Cerebral Infarction: A Prospective, Randomized, Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age 18-80 years, regardless of gender;\n2. A clinical diagnosis of acute ischemic stroke;\n3. 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;\n4. NIHSS score ≥10 at screening;\n5. Pre-stroke mRS score \\\u003C2 (independent in all activities of daily living);\n6. Time from stroke onset to initiation of the first Adacolumn treatment is ≤24 hours, stroke onset is defined as the last time the patient was known to be at their neurological baseline (wake-up strokes qualify if within this time window);\n7. All endovascular thrombectomy procedures must strictly adhere to the \"2024 Chinese Stroke Association Guidelines for Reperfusion Therapy in Acute Ischemic Stroke\" and the latest prescribing information\u002Finstructions for use regarding indications, contraindications, and procedural standards;\n8. Written informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n1. Decompressive craniectomy performed before enrollment or between enrollment and initiation of study treatment;\n2. Patients who receive intravenous thrombolysis (including bridging therapy) for the index ischemic stroke episode before or during endovascular thrombectomy; or undergo permanent intracranial or extracranial stent implantation (including intracranial stent-assisted thrombectomy or carotid stenting) during the index endovascular procedure;\n3. 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);\n4. Large-vessel occlusion is attributed to other determined etiologies per TOAST classification, such as tumor-related, dissection-related, or other clearly identifiable non-LAA\u002Fnon-CE causes.\n5. Clinical signs of brain herniation, such as unilateral or bilateral fixed dilated pupils and\u002For other loss of brainstem reflexes attributable to cerebral edema or herniation in the investigator's opinion;\n6. Intracranial lesions conferring markedly increased bleeding risk (known brain tumor, arteriovenous malformation, aneurysm);\n7. Inability to undergo MRI;\n8. Absolute neutrophil count \\\u003C1.5×10⁹\u002FL or \\>15×10⁹\u002FL\n9. Absolute monocyte count \\> 1.0 ×10⁹\u002FL;\n10. Red blood cells \\\u003C3.0×10¹²\u002FL ;\n11. Active internal bleeding or bleeding tendency (such as platelet count \\\u003C100×10⁹\u002FL, INR \\>1.7, PT \\>15 seconds);\n12. Marked hypercoagulability (fibrinogen \\>700 mg\u002FdL);\n13. Intracranial or spinal surgery or severe head trauma within the past 3 months;\n14. Refractory hypertension (persistent systolic blood pressure \\>185 mmHg or diastolic \\>110 mmHg);\n15. Known allergy to components of the blood purification system (including adsorption membrane, anticoagulants);\n16. Acute ST-segment elevation myocardial infarction and\u002For acute decompensated heart failure and\u002For corrected QT interval \\>520 ms and\u002For history of cardiac arrest within the past 6 months(pulseless electrical activity, ventricular tachycardia, ventricular fibrillation, or asystole);\n17. Body temperature \\>38°C or active infection;\n18. Active autoimmune disease or immunodeficiency;\n19. Participation in another interventional clinical trial within the past 30 days;\n20. Any other condition deemed unsuitable for participation by the investigator.","ALL","18 Years","80 Years",{"count":76,"type":77},10,"ESTIMATED","INTERVENTIONAL",[80],"NA","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.",[83,84,85,86],"Cerebral Edema","Ischemic Stroke, Acute","Malignant Cerebral Edema","Anterior Circulation Brain Infarction","NOT_YET_RECRUITING","2026-05-03",{"date":90,"type":91},"2026-05-05","ACTUAL",{"date":93,"type":77},"2026-05-01",{"date":95,"type":77},"2028-12-31",{"name":5,"class":6},1]