RT Journal Article
SR Electronic
T1 Endovascular therapy for Acute ischemic Stroke Trial (EAST): study protocol for a prospective, multicentre control trial in China
JF Stroke and Vascular Neurology
FD BMJ Publishing Group Ltd
SP 44
OP 51
DO 10.1136/svn-2016-000022
VO 1
IS 2
A1 Miao, Zhongrong
A1 Huo, Xiaochuan
A1 Gao, Feng
A1 Liao, Xiaoling
A1 Wang, Chunjuan
A1 Peng, Ya
A1 Cao, Yibin
A1 Chen, Shengli
A1 Zhang, Meng
A1 Jiang, Changchun
A1 Peng, Xiaoxiang
A1 Song, Cunfeng
A1 Wei, Liping
A1 Zhu, Qiyi
A1 Guo, Zaiyu
A1 Liu, Li
A1 Lin, Hang
A1 Yang, Hua
A1 Wu, Wei
A1 Liang, Hui
A1 Xu, Anding
A1 Chen, Kangning
A1 Zhao, Xingquan
A1 Pan, Yuesong
A1 Li, Hao
A1 Liu, Liping
A1 Wang, Yilong
A1 Wang, Yongjun
A1 EAST investigators
YR 2016
UL http://svn.bmj.com/content/1/2/44.abstract
AB 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.