This is a multicenter, randomized, controlled, subject- and assessor-blinded clinical trial. The research objective is to evaluate the safety and efficacy of selective intra-arterial cooling infusion combined with endovascular therapy in the treatment of acute anterior circulation large vessel occlusion stroke. This trial aims to enroll 258 subjects. Patients assigned to the control group will receive best medical management (BMM) and endovascular therapy (EVT). Those in the selective intra-arterial cooling infusion group (IA-SCI group) will undergo selective intra-arterial cold saline infusion, in addition to BMM and EVT. Subjects will be interviewed face-to-face at randomization, 24±6 hours, 48±6 hours after randomization, 7±2 days/discharge. Telephone interviews/ face-to face interviews will be performed at 30±3 days and 90±7 days after randomization. The primary outcome is the distribution of Modified Rankin Score at 90±7days after randomization.
Age ≥ 18 and ≤ 80.
Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (intracranial segment of the internal carotid artery, middle cerebral artery M1 segment) demonstrated with CTA/MRA/DSA.
NIHSS score obtained prior to randomization ≥ 6 and ≤ 25.
Modified Rankin Scale ≤ 1 prior to qualifying stroke.
Baseline CT/MRI confirms the presence of multiple vascular territory acute strokes.
Baseline CT/MRI confirms the presence of arterial dissection.
Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
Known allergies or intolerances to antiplatelet agents, anticoagulation drugs, iodinated contrast and/or anesthetics.
Parallel
Selective Intra-arterial Cooling Infusion (IA-SCI)
Procedure/SurgeryPre-recanalization: During the procedure, the micro-catheter is advanced over a micro-guide wire, traveling up through the neck until it reaches beyond the clot. A 50 mL cold 0.9% saline (4 ℃) is infused intro into the ischemic territory at a rate of 10 mL/min via the micro-catheter. This enables the cold solution to infuse into the ischemic territory prior to revascularization. Post-recanalization: After recanalization, cold 0.9% saline (4 ℃) is reinfused into the vessel via the catheter at a rate of 22 mL/min for 10 min, repeated twice with a 10-minute interval between infusions.
Distribution of Modified Rankin scale
the distribution of Modified Rankin scale (mRS) \[ranging from 0 (normal) to 6 (death)\]
Percentage of functional independence (mRS scale 0-2)
the percentage of mRS scale 0-2 (Modified Rankin scale \[ranging from 0 (normal) to 6 (death)\])
Percentage of favorable outcome (mRS scale 0-1)
the percentage of mRS scale 0-1(Modified Rankin scale \[ranging from 0 (normal) to 6 (death)\])
Final infarction volume
A plain computed tomography (CT) scan will be performed. The infarct area is defined as the low-density area. The infarct area is semi-automatically delineated by the software. The infarct volume= the sum of the infarct area of each layer × layer thickness (5mm).
The changes of infarction volume
the changes of infarction volume between baseline and 7±2 days/discharge assessed by CT
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