Regional Hypothermia in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke

• Age ≥18 and ≤80
• Clinical signs consistent with the diagnosis of an acute ischemic stroke
• Baseline NIHSS score obtained prior to randomization ≥8
• Intracranial arterial occlusion of the distal intracranial carotid artery or
• Middle (M1/M2), demonstrated with CTA, MRA, DSA
• The possibility to start treatment (artery puncture) within 6 hours from onset
• Regional hypothermia is expected to start within 15 minutes after recanalization
• Informed consent given

Exclusion Criteria:

• mTICI\<2b after endovascular treatment
• No significant pre-stroke disability (mRS ≤1)
• Previous NYHA grade > 1
• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
• Baseline platelet count \< 50000/µL
• Baseline blood glucose of \< 50mg/dL or >400mg/dl
• Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg). NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using local treatment guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
• Seizures at stroke onset which would preclude obtaining a baseline NIHSS
• Subjects who have received iv t-PA treatment beyond 4,5 hours from the beginning of the symptoms
• Renal insufficiency with creatinine ≥ 3 mg/dl
• Woman of childbearing potential who is known to be pregnant or lactating
• Subject participating in a study involving an investigational drug or device that would impact this study
• Cerebral vasculitis
• Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
• Unlikely to be available for 3 months follow-up (e.g. no fixed home address, visitor from overseas).
• CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed)
• ASPECT\<6
• Subjects with occlusions in multiple vascular territories (anterior circulation and posterior circulation)
• Evidence of intracranial tumor (except small meningioma)