急性颅内远端中等血管闭塞性卒中的血管内治疗：研究方案与原理

Endovascular treatment in acute intracranial distal medium vessel occlusion stroke: Study protocol and rationale.

作者信息

Jing XiaoZhong, Nogueira Raul G, Nguyen Thanh N, Tao Chunrong, Zhu Yuyou, Li Rui, Sun Jun, Wang Li, Zhang Chao, Liu Tianlong, Song Jianlong, Saver Jeffrey L, Hu Wei

机构信息

Department of Neurology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.

The UPMC Stroke Institute, Department of Neurology, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.

出版信息

Int J Stroke. 2025 Jul;20(6):763-768. doi: 10.1177/17474930251332753. Epub 2025 Mar 25.

DOI:10.1177/17474930251332753

PMID:40134089

Abstract

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.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06146790.

摘要

背景

远端中型血管闭塞（MeVO）约占所有急性缺血性卒中的25%至40%。非随机试验的新证据表明，血管内血栓切除术（EVT）在MeVO卒中中可实现较高的成功再灌注率，其安全性与近端动脉闭塞的EVT相当。这些发现强调了进行前瞻性随机临床试验以评估EVT治疗MeVO卒中的安全性和有效性的必要性。

目的

本试验旨在评估EVT治疗MeVO卒中的安全性和有效性。

方法与设计

急性颅内远端中型血管闭塞性卒中血管内治疗试验（ORIENTAL-MeVO）是一项由研究者发起的、多中心、前瞻性、随机临床试验，采用开放标签治疗和盲法终点评估（PROBE）。在中国50多个综合卒中中心，将在2年时间内连续纳入多达564例符合条件的患者，以1:1的比例随机分组，分别接受EVT或标准治疗。