XiaoZhong Jing, Raul G Nogueira, Thanh N Nguyen, Chunrong Tao, Yuyou Zhu, Rui Li, Jun Sun, Li Wang, Chao Zhang, Tianlong Liu, Jianlong Song, Jeffrey L Saver, Wei Hu
{"title":"急性颅内远端中血管闭塞性卒中的血管内治疗：研究方案和基本原理。","authors":"XiaoZhong Jing, Raul G Nogueira, Thanh N Nguyen, Chunrong Tao, Yuyou Zhu, Rui Li, Jun Sun, Li Wang, Chao Zhang, Tianlong Liu, Jianlong Song, Jeffrey L Saver, Wei Hu","doi":"10.1177/17474930251332753","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Distal medium vessel occlusions (MeVOs) account for an estimated 25% to 40% of all acute ischemic strokes. Emerging evidence from non-randomized trials suggest that endovascular thrombectomy (EVT) can achieve high rates of successful reperfusion in MeVO strokes, with a safety profile comparable to EVT for proximal arterial occlusions. These findings underscore the need for a prospective randomized clinical trial to evaluate the safety and efficacy of EVT for MeVO stroke.</p><p><strong>Objective: </strong>This trial aims to evaluate the safety and efficacy of EVT for MeVO stroke.</p><p><strong>Methods and design: </strong>Endovascular treatment in acute intracranial distal medium vessel occlusion stroke (ORIENTAL-MeVO) is an investigator-initiated, multicenter, prospective, randomized clinical trial with open-label treatment and blinded endpoint assessment (PROBE). Up to 564 eligible patients will be consecutively randomized in a 1:1 ratio to receive either EVT or standard of care over a period of 2 years in over 50 comprehensive stroke centers in China.</p><p><strong>Outcomes: </strong>The primary outcome is a shift in the distribution of the modified Rankin Scale (mRS) at day 90s with levels 5-6 combined (mRS = 0, 1, 2, 3, 4, 5-6). Primary safety endpoints include symptomatic intracerebral hemorrhage at 24 h and mortality at 90 days.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06146790.</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":" ","pages":"763-768"},"PeriodicalIF":8.7000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Endovascular treatment in acute intracranial distal medium vessel occlusion stroke: Study protocol and rationale.\",\"authors\":\"XiaoZhong Jing, Raul G Nogueira, Thanh N Nguyen, Chunrong Tao, Yuyou Zhu, Rui Li, Jun Sun, Li Wang, Chao Zhang, Tianlong Liu, Jianlong Song, Jeffrey L Saver, Wei Hu\",\"doi\":\"10.1177/17474930251332753\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Distal medium vessel occlusions (MeVOs) account for an estimated 25% to 40% of all acute ischemic strokes. Emerging evidence from non-randomized trials suggest that endovascular thrombectomy (EVT) can achieve high rates of successful reperfusion in MeVO strokes, with a safety profile comparable to EVT for proximal arterial occlusions. These findings underscore the need for a prospective randomized clinical trial to evaluate the safety and efficacy of EVT for MeVO stroke.</p><p><strong>Objective: </strong>This trial aims to evaluate the safety and efficacy of EVT for MeVO stroke.</p><p><strong>Methods and design: </strong>Endovascular treatment in acute intracranial distal medium vessel occlusion stroke (ORIENTAL-MeVO) is an investigator-initiated, multicenter, prospective, randomized clinical trial with open-label treatment and blinded endpoint assessment (PROBE). Up to 564 eligible patients will be consecutively randomized in a 1:1 ratio to receive either EVT or standard of care over a period of 2 years in over 50 comprehensive stroke centers in China.</p><p><strong>Outcomes: </strong>The primary outcome is a shift in the distribution of the modified Rankin Scale (mRS) at day 90s with levels 5-6 combined (mRS = 0, 1, 2, 3, 4, 5-6). 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Endovascular treatment in acute intracranial distal medium vessel occlusion stroke: Study protocol and rationale.
Background: Distal medium vessel occlusions (MeVOs) account for an estimated 25% to 40% of all acute ischemic strokes. Emerging evidence from non-randomized trials suggest that endovascular thrombectomy (EVT) can achieve high rates of successful reperfusion in MeVO strokes, with a safety profile comparable to EVT for proximal arterial occlusions. These findings underscore the need for a prospective randomized clinical trial to evaluate the safety and efficacy of EVT for MeVO stroke.
Objective: This trial aims to evaluate the safety and efficacy of EVT for MeVO stroke.
Methods and design: Endovascular treatment in acute intracranial distal medium vessel occlusion stroke (ORIENTAL-MeVO) is an investigator-initiated, multicenter, prospective, randomized clinical trial with open-label treatment and blinded endpoint assessment (PROBE). Up to 564 eligible patients will be consecutively randomized in a 1:1 ratio to receive either EVT or standard of care over a period of 2 years in over 50 comprehensive stroke centers in China.
Outcomes: The primary outcome is a shift in the distribution of the modified Rankin Scale (mRS) at day 90s with levels 5-6 combined (mRS = 0, 1, 2, 3, 4, 5-6). Primary safety endpoints include symptomatic intracerebral hemorrhage at 24 h and mortality at 90 days.
期刊介绍：
The International Journal of Stroke is a welcome addition to the international stroke journal landscape in that it concentrates on the clinical aspects of stroke with basic science contributions in areas of clinical interest. Reviews of current topics are broadly based to encompass not only recent advances of global interest but also those which may be more important in certain regions and the journal regularly features items of news interest from all parts of the world. To facilitate the international nature of the journal, our Associate Editors from Europe, Asia, North America and South America coordinate segments of the journal.
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