To Evaluate the Safety and Efficacy of the Super-Bore 8/7F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
360
For 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.
For 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 First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
RECRUITINGThe Rates of First Pass Effect (eTICI2c-3)
Evaluate effect of thrombectomy on reperfusion
Time frame: Within 5 minutes at final angiography of thrombectomy
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)
Time frame: 90 (± 14 days) after procedure
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)
Time frame: 90 (± 14 days) after procedure
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