A Multicenter, Randomized Controlled Clinical Investigation to Evaluate the Safety and Effectiveness of the Super-Bore 8/7F Aspiration Catheters in the Treatment of Acute Intracranial Large Vessel Occlusion
Trial Parameters
Brief Summary
To Evaluate the Safety and Efficacy of the Super-Bore 8/7F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 years or older; 2. Clinical presentation consistent with acute ischemic stroke (AIS); 3. Able to receive mechanical thrombectomy within 24 hours of onset; 4. Pre-morbid mRS score of 0 or 1; 5. Baseline NIHSS score of 6 or greater; 6. Complete or near-complete occlusion (eTICI 0-1) of the intracranial segment of the internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or the basilar artery (with or without involvement of the intracranial vertebral artery) confirmed by angiography who can undergo intravascular thrombectomy; 7. Vessel diameter ≥2.2 mm at the occlusion site; 8. ASPECTS or PC-ASPECTS score of 6-10 on NCCT, CTA-source imaging, or DWI-MRI; 9. Written informed consent obtained from the patient or the patient's qualified representative. Exclusion Criteria: 1. Pregnant or lactating women; 2. Severe allergic reactions to contrast agents; 3. Current participation in other clinical studies; 4. Known hereditary or acquired