Long-term effects of Enterprise self-expanding intracranial stent implantation in the treatment of carotid artery stenosis in patients with ischemic stroke: study protocol for a randomized controlled trial

Abstract

Background: The Enterprise stent system (Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd., China) is a closed-loop, recoverable self-expanding stent that is effective in the treatment of intracranial aneurysm. However, most studies on the treatment of intracranial aneurysm after ischemic stroke are case series or case reports. Methods/Design: We will perform a single-center, double-blind, randomized parallel-controlled trial at the Department of Neurology, Beijing Chao-yang Hospital, Capital Medical University, China. A cohort of 100 patients with atherosclerotic ischemic stroke will be randomly allocated to undergo either Enterprise self-expanding intracranial stent implantation in combination with antiplatelet medication (stent implantation group, n = 50) or only antiplatelet medication (drug group, n = 50) for treatment of carotid artery stenosis. Four time points (0.5, 1, 2, and 3 years after stent implantation or antiplatelet medication) will be selected for outcome observation and evaluation. The primary outcome will be the National Institutes of Health Stroke Scale score, which is used to evaluate neurologic deficits. The secondary outcomes will be the Barthel index and carotid stenosis rate. Discussion: There is a lack of randomized controlled studies addressing the long-term effects of the Enterprise self-expanding intracranial stent system for carotid artery stenosis in patients with ischemic stroke. This study will investigate and further confirm the clinical significance of the Enterprise stent system in the treatment of carotid artery stenosis in patients with ischemic stroke. Trial registration: This trial was registered at ClinicalTrial.gov (NCT02802072). Ethics: The study protocol has been approved by the Ethics Committee of Beijing Chao-yang Hospital, Captical Medical University, China (approval number: GJCY16012) and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from participants or their guardians prior to inclusion in this study.