Super Large Bore Catheter Aspiration Versus Stent Retriever Thrombectomy as First Line Technique for Anterior Circulation Large Vessel Occlusion in Acute Ischemic Stroke
This is a multicenter, open-label, blinded-endpoint, randomized controlled trial comparing super large bore catheter aspiration versus stent retriever thrombectomy as the first-line technique for anterior circulation large vessel occlusion in acute ischemic stroke. Eligible patients with acute ischemic stroke due to internal carotid artery intracranial segment and/or middle cerebral artery M1 occlusion will be randomized 1:1 to receive either aspiration using a super large bore catheter (inner diameter ≥0.080 inch) or stent retriever thrombectomy (allowing balloon guiding catheters or intermediate catheters with inner diameter \<0.080 inch). The primary outcome is the ordinal modified Rankin Scale score at 90 days post-procedure. Key secondary outcomes include the proportion of patients with mRS 0-2 at 90 days, change in NIHSS at 24 hours and 7 days, and various angiographic and safety endpoints. The trial plans to enroll 708 patients across approximately 30 centers in China. The total study duration is 24-36 months, with each patient participating for 3 months.
• Age ≥ 18 years;
• Clinically diagnosed with acute ischemic stroke, and pre-procedure imaging confirms that the culprit vessel is occlusion of the intracranial segment of the internal carotid artery and/or the middle cerebral artery M1 segment;
• Pre-stroke modified Rankin Scale (mRS) score of 0-1;
• Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
• Alberta Stroke Program Early CT Score (ASPECTS) ≥ 3;
• Time from symptom onset to initiation of endovascular treatment (arterial puncture) \< 24 hours; symptom onset time is defined as the last known well time;
• Intravenous thrombolysis and/or mechanical thrombectomy are performed according to local guidelines, and intravenous thrombolysis does not delay mechanical thrombectomy;
• Written informed consent is obtained from the patient or a family member.