Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis: study protocol of a randomised controlled trial

Xiao-Ping Cui, Min Lin, Jun-Shan Mu, Jian-Xin Ye, Wen-Qing He, Mao-Lin Fu, Hua Li, Jia-Yang Fang, Feng-Feng Shen, Hang Lin, Xiao-Ping Cui, Min Lin, Jun-Shan Mu, Jian-Xin Ye, Wen-Qing He, Mao-Lin Fu, Hua Li, Jia-Yang Fang, Feng-Feng Shen, Hang Lin

Abstract

Introduction: Whether adding percutaneous transluminal angioplasty and stenting (PTAS) to background medical treatment is effective for decreasing the incidence of stroke or death in patients with symptomatic intracranial atherosclerosis (ICAS) is still controversial. We perform a randomised controlled trial to examine the effectiveness and safety of an improved PTAS procedure for patients with ICAS.

Methods and analysis: A randomised controlled trial will be conducted in three hospitals in China. Eligible patients with ICAS will be randomly assigned to receive medication treatment (MT) plus PTAS or MT alone. The MT will be initiated immediately after randomisation, while the PTAS will be performed when patients report relief of alarm symptoms defined as sudden weakness or numbness. All patients will be followed up at 30 days, 3 and 12 months after randomisation. The primary end point will be the incidence of stroke or death at 30 days after randomisation. Secondary outcomes will be the incidence of ischaemic stroke in the territory of stenosis arteries, the incidence of in-stent restenosis, the Chinese version of the modified Rankin Scale and the Chinese version of the Stroke-Specific Quality of Life (CSQoL).

Ethics and dissemination: The study protocol is approved by institutional review boards in participating hospitals (reference number FZ20160003, 180PLA20160101 and 476PLA2016007). The results of this study will be disseminated to patients, physicians and policymakers through publication in a peer-reviewed journal or presentations in conferences. It is anticipated that the results of this study will improve the quality of the current PTAS procedure and guide clinical decision-making for patients with ICAS.

Trial registration number: NCT02689037.

Keywords: Angioplasty and Stenting; study protocol; symptomatic intracranial atherosclerosis.

Conflict of interest statement

Conflicts of Interest: None declared.

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

Figures

Figure 1
Figure 1
Flow chart of the study. ICAS, intracranial artery stenosis. PTAS, percutaneous transluminal angioplasty and stenting. MT, medication treatment.
Figure 2
Figure 2
Schedule of enrolment, intervention and assessments. MT, medication treatment. PTAS, percutaneous transluminal angioplasty and stenting. mRS, the Chinese version of the modified Rankin Scale. CSQoL, the Chinese version of Stroke-specific Quality of Life.

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