Emergency Stroke Unit With NeuAngio-CT (ESU-ACT)

This study employs a multicenter, matched-cluster controlled design wherein 5 to 10 hospitals equipped with Neusoft Medical's domestic sliding-gantry Angio-CT/Digital Subtraction Angiography (ACT/DSA) system, and staffed by personnel who have completed standardized operational training, will be selected as the Exposure Group, while a corresponding 5 to 10 matched hospitals lacking this integrated system will serve as the Control Group. In the Exposure Group, the protocol dictates an optimized direct-to-angiography suite workflow; upon arrival, patients undergo immediate neurological evaluation utilizing the Rapid Arterial oCclusion Evaluation (RACE) scale and stat laboratory testing before being transferred directly to the angio suite. Intra-suite imaging is then acquired via the sliding-gantry system to perform non-contrast computed tomography (NCCT) and CT angiography (CTA). If a large vessel occlusion (LVO) is confirmed-specifically involving the M1/M2, P1, A1, or basilar artery (BA) segments-endovascular therapy (EVT), encompassing mechanical thrombectomy, balloon angioplasty, and/or stenting, is initiated immediately on the same table. For patients without an identified LVO, intravenous thrombolysis (IVT) is administered in situ if clinical eligibility is met. Conversely, patients in the Control Group will adhere to standard-of-care diagnostic pathways, undergoing initial cross-sectional neuroimaging (NCCT/CTA or MRI/MRA) in a conventional Radiology Department, where IVT is administered in accordance with current guidelines; if an LVO is radiologically confirmed during this standard workflow, patients are subsequently transferred to a separate angiography suite to undergo EVT.

• Inclusion Criteria:

• Age ≥ 18 years;
• Clinically diagnosed with acute ischemic stroke;
• RACE score ≥ 4 points upon hospital arrival;
• Time from symptom onset/last known normal to hospital arrival ≤ 6 hours;
• Pre-stroke mRS score 0-1;
• Informed consent signed by the patient or their legal representative.
• Exclusion Criteria:

• Hemorrhagic stroke diagnosed by cranial CT or MRI during this current episode;
• Uncontrolled hypertension with medication (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg) (Note: Patients may be included if blood pressure can be successfully reduced and maintained at an acceptable level with medication);
• Known hereditary or acquired bleeding tendency, such as coagulation factor deficiency, or INR > 3.0 or PT > 3 times the normal range after anticoagulant therapy (Patients without a history of coagulation dysfunction or suspected coagulation dysfunction do not need to wait for laboratory results of INR or prothrombin time before enrollment);
• Received heparin, low-molecular-weight heparin (e.g., dalteparin sodium), or thrombin inhibitors (e.g., bivalirudin, argatroban) within 24 hours with a history of coagulation disorders;
• Baseline laboratory values: blood glucose < 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L), hemoglobin count < 7 mmol/l (11.28 g/dl); platelet count < 50,000/μl;
• Patients with renal failure, defined as serum creatinine > 3.0 mg/dl (264 μmol/l) (Note: Patients undergoing dialysis can be included regardless of serum creatinine level);
• Cerebral embolism caused by septic emboli or bacterial endocarditis;
• History of stroke within the past 3 months;
• Seizure at stroke onset leading to diagnostic confusion and difficulty in accurate baseline RACE assessment;
• History of previous neuropsychiatric disorders that make accurate neurological function assessment difficult, such as dementia patients taking cholinesterase inhibitors;
• Diagnosis of cerebral vasculitis, brain tumor, or traumatic brain injury within the past 3 months;
• Major organ surgery or biopsy within 30 days;
• Active bleeding or recent bleeding within 30 days;
• History of previous intracranial stent implantation;
• History of severe contrast agent allergy (non-rash allergy);
• Patients with other contraindications to reperfusion therapy or who refuse reperfusion therapy;
• Life expectancy less than 180 days;
• Lactating women or women with positive pregnancy test on admission;
• Patients who refuse or cannot cooperate with follow-up.