Super Large Bore Catheter Aspiration Versus Stent Retriever Thrombectomy as First Line Technique for Anterior Circulation Large Vessel Occlusion in Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 708
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Imaging shows acute or subacute intracranial hemorrhage (excluding microbleeds);
- •Imaging indicates an intracranial tumor (excluding meningiomas <2 cm in diameter) or mass effect caused by a tumor, such as midline shift;
- •Cerebral embolism caused by infection or bacterial endocarditis;
- •The culprit vessel lesion is considered to be chronic atherosclerotic stenosis and occlusion;
- •Pre-procedure imaging suggests that the lesion is due to dissection;
- •Previous intracranial aneurysm or vascular malformation in the culprit vessel;
- •Presence of a life-threatening illness within 6 months that would prevent 3-month follow-up;
- •Pregnancy, psychiatric illness, severe hepatic or renal insufficiency, severe heart failure;
- •Concurrent participation in another clinical drug or device study;
- •Metastatic tumor;
- •Systemic infection;
- •Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
研究组 & 干预措施
Super Large Bore Catheter Aspiration
A super large bore aspiration catheter with an inner diameter (ID) ≥0.080 inch is preferred as the first-line device for simple aspiration thrombectomy.
干预措施: Super Large Bore Catheter (Procedure)
Stent Retriever Thrombectomy
Stent retriever thrombectomy is preferred as the first-line technique.
干预措施: Stent Retriever Thrombectomy (Procedure)
研究者
Yueqi Zhu
Chief of Radiology department
Shanghai Jiao Tong University Affiliated Sixth People's Hospital