To Evaluate the Safety and Efficacy of the Super-Bore 8/7F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion.
Aged 18 years or older;
Clinical presentation consistent with acute ischemic stroke (AIS);
Able to receive mechanical thrombectomy within 24 hours of onset;
Pre-morbid mRS score of 0 or 1;
Pregnant or lactating women;
Severe allergic reactions to contrast agents;
Current participation in other clinical studies;
Known hereditary or acquired bleeding disorders, platelet count <50,000/µL, or coagulation factor deficiencies;
Parallel
Super-Bore Thrombosis Aspiration Catheter treatment group
Procedure/SurgeryFor the subjects randomized to the Super-Bore Thrombosis Aspiration Catheter treatment group, Mechanical thrombectomy will be performed using a Super-Bore 8/7F Thrombosis Aspiration Catheter.
Conventional thrombectomy device treatment group
Procedure/SurgeryFor the subjects randomized to the conventional thrombectomy device treatment group, mechanical thrombectomy will be performed using a commonly used thrombectomy devices in clinic, except for Super-Bore 8/7F Thrombosis Aspiration Catheter.
The Rates of First Pass Effect (eTICI2c-3)
Evaluate effect of thrombectomy on reperfusion
Proportion of mRS 0-2 at 90 days
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (Ordinal Shift Analysis);
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Symptomatic intracerebral hemorrhage (sICH)
sICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 24 hours , or any hemorrhage leading to death.
mortality
Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%
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