Endovascular therapy for Acute ischemic Stroke Trial (EAST): study protocol for a prospective, multicentre control trial in China

Zhongrong Miao, Xiaochuan Huo, Feng Gao, Xiaoling Liao, Chunjuan Wang, Ya Peng, Yibin Cao, Shengli Chen, Meng Zhang, Changchun Jiang, Xiaoxiang Peng, Cunfeng Song, Liping Wei, Qiyi Zhu, Zaiyu Guo, Li Liu, Hang Lin, Hua Yang, Wei Wu, Hui Liang, Anding Xu, Kangning Chen, Xingquan Zhao, Yuesong Pan, Hao Li, Liping Liu, Yilong Wang, Yongjun Wang, EAST investigators, Zhongrong Miao, Xiaochuan Huo, Feng Gao, Xiaoling Liao, Chunjuan Wang, Ya Peng, Yibin Cao, Shengli Chen, Meng Zhang, Changchun Jiang, Xiaoxiang Peng, Cunfeng Song, Liping Wei, Qiyi Zhu, Zaiyu Guo, Li Liu, Hang Lin, Hua Yang, Wei Wu, Hui Liang, Anding Xu, Kangning Chen, Xingquan Zhao, Yuesong Pan, Hao Li, Liping Liu, Yilong Wang, Yongjun Wang, EAST investigators

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.

Keywords: Acute Ischemic Stroke; Endovascular therapy; Mechanical Thrombectomy; Solitaire Device.

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Endovascular therapy for Acute ischemic Stroke Trial (EAST) study enrolment clinical procedure.
Figure 2
Figure 2
Solitaire revascularisation device clinical procedure. BP, blood pressure; CTA, CT angiography; IFU, instruction for use; MRA, MR angiography; mTICI, modified Thrombolysis in Cerebral Infarction; NIHSS, National Institute of Health Stroke Scale.

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Source: PubMed

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