Endovascular therapy for Acute ischemic Stroke Trial (EAST): study protocol for a prospective, multicentre control trial in China. Issue 2 (16th June 2016)

• Record Type: Journal Article
• Authors: Miao, Zhongrong; Huo, Xiaochuan; Gao, Feng; Liao, Xiaoling; Wang, Chunjuan; Peng, Ya; Cao, Yibin; Chen, Shengli; Zhang, Meng; Jiang, Changchun; Peng, Xiaoxiang; Song, Cunfeng; Wei, Liping; Zhu, Qiyi; Guo, Zaiyu; Liu, Li; Lin, Hang; Yang, Hua; Wu, Wei; Liang, Hui; Xu, Anding; Chen, Kangning; Zhao, Xingquan; Pan, Yuesong; Li, Hao; Liu, Liping; Wang, Yilong; Wang, Yongjun
• Other Names: author non-byline.; Saver Jeffrey L author non-byline.; Broderick Joseph P author non-byline.; Feng Lei author non-byline.; Ma Ning author non-byline.; Mo Dapeng author non-byline.; Shen Haipeng author non-byline.; Jiang Yong author non-byline.; Wang Anxin author non-byline.; Liu Gaifen author non-byline.; Wang Xianwei author non-byline.; DS Liebeskind author non-byline.; Gao Peiyi author non-byline.; Yu Wengui author non-byline.
• Is Part Of: Stroke and vascular neurology. Volume 1:Issue 2(2016)
• Page Start: 44
• Page End: 51
• Publication Date: 2016-06-16
• Subjects: Acute Ischemic Stroke -- Mechanical Thrombectomy -- Solitaire Device -- Endovascular therapy; Cerebrovascular disease -- Periodicals; Cardiovascular system -- Diseases -- Periodicals; 616.81005
• DOI: 10.1136/svn-2016-000022
• Languages: English
• ISSNs: 2059-8688

Abstract

Abstract : Background and purpose: 5 recent trials have shown the benefit of endovascular treatment for acute ischaemic stroke (AIS) due to large vessel occlusion of the anterior circulation. This study aims to evaluate the safety and efficacy of Solitaire thrombectomy in patients with moderate-to-severe stroke in the Chinese population, which has a high prevalence of intracranial atherosclerosis. Methods and analysis: This multicentre prospective control study will involve 17 stroke centres in China, and plans to recruit 150 patients in the intervention group, and 150 patients in the medical group, in which patients meet enrolment criteria but refuse intervention. Patients with AIS due to large vessel occlusion indicated for treatment with Solitaire stent retriever within 12 hours of symptom onset, and who meet the inclusion and exclusion criteria, will be enrolled in this study. The primary efficacy endpoint is functional independence as defined by a modified Rankin Scale (mRS) score ≤2 at 90 days or by functional improvement as defined by mRS, using shift analysis. The procedural efficacy endpoint is arterial recanalisation of the occluded target vessel measured by a modified Thrombolysis in Cerebral Infarction (mTICI) score equal or superior to 2b right following the use of the study device. The primary safety endpoint is symptomatic intracranial haemorrhage (sICH) within 24±3 hours postprocedure. Ethics and dissemination: The protocol was approved by the Ethics Committee at the coordinating centre and by the local Institutional Review Board of each participating centre. Trial registration number: NCT02350283.