Fransen Puck S S, Beumer Debbie, Berkhemer Olvert A, van den Berg Lucie A, Lingsma Hester, van der Lugt Aad, van Zwam Wim H, van Oostenbrugge Robert J, Roos Yvo B W E M, Majoie Charles B, Dippel Diederik W J
Department of Neurology, Erasmus MC University Medical Center, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.
Trials. 2014 Sep 1;15:343. doi: 10.1186/1745-6215-15-343.
Endovascular or intra-arterial treatment (IAT) increases the likelihood of recanalization in patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion. However, a beneficial effect of IAT on functional recovery in patients with acute ischemic stroke remains unproven. The aim of this study is to assess the effect of IAT on functional outcome in patients with acute ischemic stroke. Additionally, we aim to assess the safety of IAT, and the effect on recanalization of different mechanical treatment modalities.
METHODS/DESIGN: A multicenter randomized clinical trial with blinded outcome assessment. The active comparison is IAT versus no IAT. IAT may consist of intra-arterial thrombolysis with alteplase or urokinase, mechanical treatment or both. Mechanical treatment refers to retraction, aspiration, sonolysis, or use of a retrievable stent (stent-retriever). Patients with a relevant intracranial proximal arterial occlusion of the anterior circulation, who can be treated within 6 hours after stroke onset, are eligible. Treatment effect will be estimated with ordinal logistic regression (shift analysis); 500 patients will be included in the trial for a power of 80% to detect a shift leading to a decrease in dependency in 10% of treated patients. The primary outcome is the score on the modified Rankin scale at 90 days. Secondary outcomes are the National Institutes of Health stroke scale score at 24 hours, vessel patency at 24 hours, infarct size on day 5, and the occurrence of major bleeding during the first 5 days.
If IAT leads to a 10% absolute reduction in poor outcome after stroke, careful implementation of the intervention could save approximately 1% of all new stroke cases from death or disability annually.
NTR1804 (7 May 2009)/ISRCTN10888758 (24 July 2012).
血管内或动脉内治疗（IAT）可增加由颅内近端动脉闭塞引起的急性缺血性中风患者再通的可能性。然而，IAT对急性缺血性中风患者功能恢复的有益作用尚未得到证实。本研究的目的是评估IAT对急性缺血性中风患者功能结局的影响。此外，我们旨在评估IAT的安全性，以及不同机械治疗方式对再通的影响。
方法/设计：一项采用盲法结局评估的多中心随机临床试验。积极对照是IAT与非IAT。IAT可能包括用阿替普酶或尿激酶进行动脉内溶栓、机械治疗或两者皆用。机械治疗是指血栓抽吸、取栓、超声溶栓或使用可回收支架（支架取栓器）。前循环相关颅内近端动脉闭塞且在中风发作后6小时内可接受治疗的患者符合入选条件。治疗效果将通过有序逻辑回归（移位分析）进行估计；将有500名患者纳入试验，以80%的检验效能检测导致10%接受治疗患者的依赖程度降低的移位。主要结局是90天时的改良Rankin量表评分。次要结局是24小时时的美国国立卫生研究院卒中量表评分、24小时时的血管通畅情况、第5天时的梗死灶大小以及前5天内严重出血的发生情况。
如果IAT能使中风后不良结局的绝对发生率降低10%，那么谨慎实施该干预措施每年可使约1%的所有新发中风病例免于死亡或残疾。
NTR1804（2009年5月7日）/ISRCTN10888758（2012年7月24日）。
