Direct Intra-arterial thrombectomy in order to Revascularize AIS patients with large vessel occlusion Efficiently in Chinese Tertiary hospitals: A Multicenter randomized clinical Trial (DIRECT-MT)—Protocol

Author:

Yang Pengfei1,Treurniet Kilian M2,Zhang Lei1ORCID,Zhang Yongwei3,Li Zifu1,Xing Pengfei3ORCID,Zhang Yongxin1,Zhang Ping3,Wang Hao1,Hong Bo1,Dippel Diederik WJ4,Roos Yvo BWEM5,Majoie Charles BLM2,Deng Benqiang3,Liu Jianmin1,

Affiliation:

1. Neurosurgery, Changhai Hospital – Naval Medical University, Shanghai, China

2. Radiology & Nuclear Medicine, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

3. Neurology, Changhai Hospital – Naval Medical University, Shanghai, China

4. Erasmus MC University Medical Center, Neurology and Stroke Center, Rotterdam, The Netherlands

5. Neurology, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands

Abstract

Rationale Intravenous thrombolysis combined with mechanical thrombectomy (MT) has been proven safe and clinical effective in patients with acute ischemic stroke of anterior circulation large vessel occlusion. However, despite reperfusion, a considerable proportion of patients do not recover. Incidence of symptomatic intracerebral hemorrhage was similar between patients treated with the combination of intravenous thrombolysis and MT, as compared to intravenous thrombolysis alone, suggesting that this complication should be attributed to pre-treatment with intravenous thrombolysis. Conversely, intravenous thrombolysis may be beneficial in patients with small clots occluding intracranial arteries with underlying intracranial atherosclerotic disease, not accessible for MT. Aim To assess whether direct MT is non-inferior compared to combined intravenous thrombolysis plus MT in patients with AIS due to an anterior circulation large vessel occlusion, and to assess treatment effect modification by presence of intracranial atherosclerotic disease. Sample size Aim to randomize 636 patients 1:1 to receive direct MT (intervention) or combined intravenous thrombolysis plus MT (control). Design This is a multicenter, prospective, open label parallel group trial with blinded outcome assessment (PROBE design) assessing non-inferiority of direct MT compared to combined intravenous thrombolysis plus MT. Outcomes The primary outcome is the score on the modified Rankin Scale assessed blindly at 90 (±14) days. An common odds ratio, adjusted for the prognostic factors (age, NIHSS, collateral score), representing the shift on the 6-category mRS scale measured at three months, estimated with ordinal logistic regression, will be the primary effect parameter. Non-inferiority is established if the lower boundary of the 95% confidence interval does not cross 0.8. Discussion DIRECT-MT could result in improved therapeutic efficiency and cost reduction in treatment of anterior circulation large vessel occlusion stroke.

Funder

The Stroke Prevention and Control Engineering Commission of National Health and Family Planning Commission of the People's Republic of China

Wu Jieping Medical Foundation

Publisher

SAGE Publications

Subject

Neurology

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3