Abstract
BackgroundPatients 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.MethodsThe 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.DiscussionThe 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.Trial registration NCT01758614 with ClinicalTrials.gov. Registered on 24 December 2012.
Highlights
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
Patients with symptoms of cerebral ischaemia associated with ipsilateral internal carotid artery (ICA) occlusion have an annual risk of 5–8% of recurrent ischemic stroke [1, 2]; patients with symptomatic middle cerebral artery (MCA) disease have an overall stroke risk of 12.5% per year [3]
The pathophysiology of carotid and middle cerebral artery occlusion Collateral circulation Compensation by a collateral circulation is usually considered important in the pathophysiology of cerebrovascular stenosis and occlusion
Summary
Trial design The Carotid or Middle cerebral artery Occlusion Surgery Study (CMOSS) trial in China is designed to compare the safety and efficacy of EC-IC bypass surgery with medical therapy in patients with symptomatic ICA or MCA occlusion (within 120 days). It is the subproject of the ‘Five-twelfth’ National Science and Technology Support Program funded by the Chinese government and is a randomised controlled trial (RCT) that plans to enroll 330 patients with equal randomisation to surgical and nonsurgical groups.
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