Department of Interventional Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
China National Clinical Research Center for Neurological Diseases, Beijing, China.
Stroke Vasc Neurol. 2016 Jun 24;1(2):44-51. doi: 10.1136/svn-2016-000022. eCollection 2016 Jun.
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.
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.
The protocol was approved by the Ethics Committee at the coordinating centre and by the local Institutional Review Board of each participating centre.
NCT02350283.
5 项近期临床试验表明，血管内治疗对前循环大血管闭塞引起的急性缺血性脑卒中（AIS）有益。本研究旨在评估 Solitaire 血栓切除术治疗中国人群中中度至重度脑卒中患者的安全性和疗效，该人群颅内动脉粥样硬化的患病率较高。
这是一项多中心前瞻性对照研究，将纳入中国的 17 家卒中中心，计划在干预组招募 150 例患者，在药物组招募 150 例符合纳入标准但拒绝干预的患者。本研究纳入发病 12 小时内、适合采用 Solitaire 支架取栓治疗的 AIS 患者，且存在大血管闭塞，符合纳入和排除标准。主要疗效终点为 90 天改良 Rankin 量表（mRS）评分≤2 定义的功能独立性，或 mRS 定义的功能改善，采用移位分析。主要操作终点为采用研究器械后闭塞靶血管的改良脑梗死溶栓（mTICI）评分达到 2b 或以上的血管再通。主要安全性终点为术后 24±3 小时内症状性颅内出血（sICH）。
方案经协调中心伦理委员会和各参与中心的地方机构审查委员会批准。
NCT02350283。
