Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke

Prior treatment

• Previous New York Heart Association (NYHA) functional classification \>I.
• Current participation in another interventional drug or device study. For any other reasons, the responsible clinicians believe that the patient is not suitable for SI-AC.

Other illness

• Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
• Known allergies or intolerances to antiplatelet agents, anticoagulants, iodinated contrast, or anesthetics.
• Severe infection (e.g., sepsis) or multiple organ failure.
• Refractory hypertension that is difficult to control by medication (persistent systolic blood pressure (BP) \>185 mmHg or diastolic BP \>110 mmHg).
• Coronary artery stenosis \>70% or history of coronary artery bypass grafting.
• Malignant brain tumor or central nervous system infection.
• Pre-existing neurological or psychiatric diseases that could confound the neurological or functional evaluations (e.g., dementia or mental illness)

Lab values

• Known hereditary or acquired hemorrhagic diathesis; coagulation factor deficiency; recent oral anticoagulant therapy with international normalized ratio (INR)\>3.
  • Exception: Time elapsed since the last use of a novel oral anticoagulant ≥48 hours plus a normal activated partial thromboplastin time (APTT).
• Baseline platelet count \<50 × 109/L.
• Blood glucose concentration \<50 mg/dL (2.7 mmol/L) or \>400 mg/dL (22.2 mmol/L).
• Undergoing hemodialysis or peritoneal dialysis; severe renal insufficiency with a glomerular filtration rate \<30 mL/min or serum creatinine \>220 mmol/L (2.5 mg/dL).

Other

• Baseline CT/MRI reveals the presence of acute infarction in multiple vascular territories.
• CTA/MRA/DSA confirms the presence of arterial dissection.
• Known intracranial aneurysm or cerebral arteriovenous malformation.
• Pregnant or lactating at admission.
• Anticipated life expectancy \<6 months.

• Age ≥18 and ≤80.
• Clinical signs consistent with AIS-LVO in the anterior circulation (intracranial segment of internal carotid artery, M1 segment of middle cerebral artery (MCA) demonstrated by computed tomography angiography (CTA) / magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA)).
• National Institutes of Health Stroke Scale (NIHSS) score (at screening) ≥6 and ≤25.
• Modified Rankin Scale (mRS) score ≤1 before stroke onset.
• Arterial puncture performed within 24 hours of symptom onset or last known well (LKW).
• Written informed consent obtained from the patients or legally authorized representatives.
  • For patients admitted to the hospital within 6 hours of symptom onset, an Alberta Stroke Program Early CT Score (ASPECTS) ≥6 is required. For those admitted between 6 and 24 hours, the neuroimaging criteria of the DAWN or DEFUSE-3 trials are applied.