First-in-man Study of the Cerebrovascular Interventional Procedural Control System
Acute Ischemic Stroke
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility Criteria
Inclusion Criteria: Age 18-80. Diagnosed with acute ischemic stroke. Arterial occlusion in the anterior cerebral circulation that was confirmed by CTA or MRA. Subject could be treated intraarterially within 8 hours after symptom onset. Prestroke Modified Rankin Score ≤ 1. National Institutes of Health Stroke Scale (NIHSS) ≥6 and ≤20. Patients or their legally authorised representatives provided signed, informed consent. Exclusion Criteria: NCCT ASPECT score <6,or the infarct volume exceeded 1/3 of the middle cerebral artery blood supply area. CT/MR Showed midline shift or cerebral hernia, and ventricle occupying effect. Intracranial hemorrhage. CTA/MRA shows carotid artery dissection, severe stenosis, or complete occlusion, which requiring carotid stent implantation during thrombectomy; Bilateral acute stroke or multiple intracranial large vessel occlusion. Females who are pregnant or lactating. Severe allergy to contrast agents, nickel-titanium metal or its alloys. Drug-resistant hypertension (defined as sustained systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg). Hemorrhagic tendency (including but not limited to platelet <100*109/L, heparin treatment within 48 hours with APTT ≥35s, taking warfarin with an INR > 1.7). Surgery or biopsy of parenchymal organs within the last 1 month Any active or recent bleeding (gastrointestinal, urinary, etc.) within the last 1 month Undergoing hemodialysis or peritoneal dialysis; exist of severe renal insufficiency (serum creatinine >220umol/L or 2.5mg/dl) Previous intracranial hemorrhage, subarachnoid hemorrhage, brain tumor. Life expectancy of less than 1 year. Enrollment in another clinical trial evaluating other devices or drugs during the same period. Abnormalities or diseases that the investigator considers to be excluded from the study's coverage.
Sites / Locations
- Beijing Tiantan HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Experimental Group
Patients with acute ischemic stroke will receive interventional procedure by the Cerebrovascular Interventional Procedural Control System.