Protocol for a prospective, multicentre registry study of stenting for symptomatic intracranial artery stenosis in China

Yilong Wang, Zhongrong Miao, Yongjun Wang, Xingquan Zhao, Peiyi Gao, Liping Liu, Feng Wang, Yajie Liu, Ning Ma, Ziqi Xu, Dapeng Mo, Feng Gao, China registry study group, Yilong Wang, Zhongrong Miao, Yongjun Wang, Xingquan Zhao, Peiyi Gao, Liping Liu, Feng Wang, Yajie Liu, Ning Ma, Ziqi Xu, Dapeng Mo, Feng Gao, China registry study group

Abstract

Introduction: The SAMMPRIS trial suggested that aggressive treatment was superior to endovascular stenting in patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS) due to high complication rates in patients in the stenting group. Given that 12.2% patients failed aggressive medical therapy in the SAMMPRIS study, it is imperative to perform a multicentre prospective registry study of stenting for patients with ICAS in China. This study aims to evaluate the safety and efficacy of endovascular stenting for patients with symptomatic intracranial artery stenosis and poor collaterals in China and to identify the characteristics of the population that would benefit the most from endovascular stenting in Chinese patients.

Methods and analysis: This multicentre prospective registry study will involve 20 stroke centres in China, and plans to recruit 300 patients into the registry. Patients with ≥70% stenosis and symptomatic intracranial atherosclerotic disease caused by hypoperfusion combined with poor collaterals who met the inclusion criteria and exclusion criteria would be enrolled for this study. The primary outcome is the target vessel stroke event (including haemorrhagic or ischaemic stroke) or death within 30 days after stenting. The secondary outcomes include the successful recanalisation rate, the incidence of recurrent ischaemic stroke in the territory of the stented artery between 30 days and 1 year postoperatively, the restenosis rate and health-related quality of life.

Ethics and dissemination: The protocol is approved by the ethics committee at the coordinating centre and by the local institutional review board at each participating centre. Findings will be shared with participating hospitals, policymakers and the academic community to promote quality monitoring, quality improvement and the efficient allocation and use of cerebral catheterisation and intracranial artery stenting in China.

Trial registration number: http://www.clinicaltrials.gov (NCT01968122).

Keywords: Stroke medicine

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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