Overview

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.

Eligibility

Inclusion Criteria:

1. Age ≥ 18 years;
2. 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;
3. Pre-stroke modified Rankin Scale (mRS) score of 0-1;
4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
5. Alberta Stroke Program Early CT Score (ASPECTS) ≥ 3;
6. Time from symptom onset to initiation of endovascular treatment (arterial puncture) \< 24 hours; symptom onset time is defined as the "last known well" time;
7. Intravenous thrombolysis and/or mechanical thrombectomy are performed according to local guidelines, and intravenous thrombolysis does not delay mechanical thrombectomy;
8. Written informed consent is obtained from the patient or a family member.

Exclusion Criteria:

1. Imaging shows acute or subacute intracranial hemorrhage (excluding microbleeds);
2. Imaging indicates an intracranial tumor (excluding meningiomas \<2 cm in diameter) or mass effect caused by a tumor, such as midline shift;
3. Cerebral embolism caused by infection or bacterial endocarditis;
4. The culprit vessel lesion is considered to be chronic atherosclerotic stenosis and occlusion;
5. Pre-procedure imaging suggests that the lesion is due to dissection;
6. Previous intracranial aneurysm or vascular malformation in the culprit vessel;
7. Presence of a life-threatening illness within 6 months that would prevent 3-month follow-up;
8. Pregnancy, psychiatric illness, severe hepatic or renal insufficiency, severe heart failure;
9. Concurrent participation in another clinical drug or device study;
10. Metastatic tumor;
11. Systemic infection;
12. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.