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

doi:10.3969/j.issn.2095-4344.2016.34.009

Abstract

Abstract:

BACKGROUND: The Enterprise stent system 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.
OBJECTIVE: To assess the efficacy of the Enterprise stent system for the treatment of carotid artery stenosis in patients with atherosclerotic ischemic stroke.
METHODS: 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 included after obtaining written informed consent from participants or their guardians, and then 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. 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. This trial was registered at ClinicalTrial.gov (NCT02802072).
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.

中国组织工程研究杂志出版内容重点：生物材料；骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性；组织工程

Key words: Clinical Trial, Carotid Stenosis, Stents, Atherosclerosis, Randomized Controlled Trial

CLC Number:

R318

Ji Meng, Wang Wei, Hu Wen-li . 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[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(34): 5070-5075.

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