About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Adacolumn®
- Standard Reperfusion Therapy
- Standard Medical Management