DEVT: A randomized, controlled, multicenter trial of direct endovascular treatment versus standard bridging therapy for acute stroke patients with large vessel occlusion in the anterior circulation - Protocol.
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Qiu Zhongming, Liu Hansheng, Li Fengli, Luo Weidong, Wu Deping, Shi Zhonghua, Liu Wenhua, Huang Wenguo, Fu Xinmin, Qiu Tao, Wang Li, Yang Shiquan, Zhang Shuai, Wang Yan, Bai Yongjie, Liu Xuan, Li Huagang, Liu Yong, Li Wei, Wan Yue, Ai Zhibing, Yao Xiaoxi, Luo Jun, Pu Jie, Zhou Zhiming, Wang Shouchun, Wen Changming, Ling Wentong, Liu Shudong, Yang Weimin, Zeng Guoyong, Wu Youlin, Guo Fuqiang, Chen Shengli, Huang Junjie, Wang Zhen, Peng Miao, Zhang Min, Zhou Peiyang, Chen Luming, Liu Shuai, Yue Chengsong, Yang Jun, Gong Zili, Shuai Jie, Sang Hongfei, Nogueira Raul G, Zi Wenjie, Yang Qingwu, DEVT study investigators
Аннотация
OBJECTIVE: This study compares the safety and efficacy of direct endovascular treatment versus intravenous recombinant tissue-type plasminogen activator bridging with endovascular treatment (bridging therapy) in acute stroke patients with intracranial internal carotid artery or middle cerebral artery-M1 occlusion within 4.5 h of symptom onset.
METHODS AND DESIGN: The DEVT study is a randomized, controlled, multicenter trial with blinded outcome assessment. This trial uses a five-look group-sequential non-inferiority design. Up to 194 patients in each interim analysis will be consecutively randomized to direct endovascular treatment or bridging therapy group in 1:1 ratio over three years from about 30 hospitals in China.
OUTCOMES: The primary end-point is the proportion of independent neurological function defined as modified Rankin scale score of 0 to 2 at 90 days. The primary safety measure is symptomatic intracerebral hemorrhage at 48 h and mortality at 90 days.
TRIAL REGISTRY NUMBER: ChiCTR-IOR-17013568 (www.chictr.org.cn).