title: The Carotid and Middle cerebral artery Occlusion Surgery Study (CMOSS): a study protocol for a randomised controlled trial.
abstract: Patients with symptomatic internal carotid artery (ICA) or middle cerebral artery (MCA) occlusion with haemodynamic insufficiency are at high risk for recurrent stroke when treated medically.
  
  
  
  The Carotid or Middle cerebral artery Occlusion Surgery Study (CMOSS) trial is an ongoing, government-funded, prospective, multicentre, randomised controlled trial. The CMOSS will recruit 330 patients with symptomatic ICA or MCA occlusion (parallel design, 1:1 allocation ratio) and haemodynamic insufficiency. Participants will be allocated to best medical treatment alone or best medicine plus extracranial-intracranial (EC-IC) bypass surgery. The primary outcome events are all strokes or deaths occurring between randomisation and 30 days post operation or post randomisation and ipsilateral ischaemic stroke within 2 years. Recruitment will be finished by December 2016. All the patients will be followed for at least 2 years. The trial is scheduled to complete in 2019.
  
  
  
  The CMOSS will test the hypothesis that EC-IC bypass surgery plus best medical therapy reduces subsequent ipsilateral ischaemic stroke in patients with symptomatic ICA or MCA occlusion and haemodynamic cerebral ischaemia. This manuscript outlines the rationale and the design of the study. CMOSS will allow for more critical reappraisal of the EC-IC bypass for selected patients in China.
  
  
  
  NCT01758614 with ClinicalTrials.gov. Registered on 24 December 2012.
authors.affiliation: Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Ma
authors.affiliation: Department of Neurosurgery, Huashan Hospital, Fu Dan University, No. 12 Mid Wulumuqi Road, Shanghai, 200040, China.
authors.forename: Yuxiang
authors.initials: Y
authors.lastname: Gu
authors.affiliation: Department of Neurosurgery, Huanhu Hospital, No. 6 Jizhao Road, Tianjin, 300350, China.
authors.forename: Xiaoguang
authors.initials: X
authors.lastname: Tong
authors.affiliation: Department of Neurosurgery, Brain Hospital, No. 45 Huashan Road, LiaoCheng, Shandong, 252000, China.
authors.forename: Jiyue
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Neurosurgery, The 1st Affiliated Hospital of ShanXi Medical University, No. 85 South Jiefang Road, Taiyuan, Shanxi, 030001, China.
authors.forename: Dong
authors.initials: D
authors.lastname: Kuai
authors.affiliation: Department of Neurosurgery, Qilu Hospital of Shandong University, No. 107 West Wenhua Road, Jinan, Shandong, 250012, China.
authors.forename: Donghai
authors.initials: D
authors.lastname: Wang
authors.affiliation: Department of Neurosurgery, The 2nd Affiliated Hospital of LanZhou University, No. 80 Cuiyingmen Road, Lanzhou, Gansu, 730030, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Ren
authors.affiliation: Department of Neurosurgery, The 307 Hospital of PLA, No. 8 Dongda Street, Beijing, 100071, China.
authors.forename: Lian
authors.initials: L
authors.lastname: Duan
authors.affiliation: Department of Neurosurgery, The 1st Affiliated Hospital of XinJiang Medical University, No. 137 South Liyushan Road, Wulumuqi, Xinjiang Uyghur Autonomous Region, 830054, China.
authors.forename: Aili
authors.initials: A
authors.lastname: Maimaiti
authors.affiliation: Department of Neurology, The 306 Hospital of PLA, No. 9 Anxiangbeili, Beijing, 100101, China.
authors.forename: Yiling
authors.initials: Y
authors.lastname: Cai
authors.affiliation: Department of Neurosurgery, Drum Tower Hospital, Medical School of Nanjing University, No. 321 Zhongshan Road, Nanjing, Jiangsu, 210008, China.
authors.forename: Yujie
authors.initials: Y
authors.lastname: Huang
authors.affiliation: Department of Neurosurgery, The 1st Affiliated Hospital of Anhui Medical University, No. 218 Jixi Road, Hefei, Anhui, 650101, China.
authors.forename: Xiaojian
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Neurosurgery, The 2nd Affiliated Hospital of Kunming Medical University, No. 324 Dianmian Road, Kunming, Yunnan, 610041, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Cao
authors.affiliation: Department of Neurosurgery, West China Hospital of Sichuan University, No. 37 Guoxue Street, Chengdu, Sichuan, 610041, China.
authors.forename: Chao
authors.initials: C
authors.lastname: You
authors.affiliation: Department of Neurosurgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Road, Wuhan, Hubei, 430030, China.
authors.forename: Jiasheng
authors.initials: J
authors.lastname: Yu
authors.affiliation: Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China. jiaoliqun@sina.cn.
authors.forename: Liqun
authors.initials: L
authors.lastname: Jiao
authors.affiliation: Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, No. 45 Changchun Street, Beijing, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Ling
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002343:Carotid Artery, Internal / Q000000981:diagnostic imaging / Q000503:physiopathology; D016893:Carotid Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D002548:Cerebral Revascularization / Q000009:adverse effects / Q000401:mortality; D002560:Cerebrovascular Circulation; D002681:China; D002985:Clinical Protocols; D003097:Collateral Circulation; D003131:Combined Modality Therapy; D005260:Female; D006439:Hemodynamics; D006801:Humans; D020244:Infarction, Middle Cerebral Artery / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002317:Cardiovascular Agents
keywords: Bypass surgery; Carotid artery; China; Haemodynamic; Ischaemic stroke; Middle cerebral artery; Occlusion