A Trial of Adacolumn on Cerebral Edema After Anterior Circulation Ischemic Stroke (NCT07386262) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Trial of Adacolumn on Cerebral Edema After Anterior Circulation Ischemic Stroke
China10 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range18 Years β 80 Years
SexALL
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Inclusion criteria
β. Age 18-80 years, regardless of gender;
β. A clinical diagnosis of acute ischemic stroke;
β. 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;
β. NIHSS score β₯10 at screening;
β. Pre-stroke mRS score \<2 (independent in all activities of daily living);
β. Time from stroke onset to initiation of the first Adacolumn treatment is β€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);
β. 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/instructions for use regarding indications, contraindications, and procedural standards;
β. Written informed consent obtained from the patient or legally authorized representative.
Exclusion criteria
β. Decompressive craniectomy performed before enrollment or between enrollment and initiation of study treatment;
β. 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;
What they're measuring
1
The change in net water uptake (NWU) on CT between the immediate post-reperfusion and 72-78 hours post-reperfusion
Timeframe: 72 hours
Trial details
NCT IDNCT07386262
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
β. After endovascular thrombectomy: extensive contrast extravasation (diffuse subarachnoid high density or parenchymal high density not consistent with hematoma), new subarachnoid hemorrhageοΌSAHοΌ, or symptomatic intracranial hemorrhage (sICH);
β. 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.
β. 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;