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
Ji Meng
Wang Wei
Hu Wen-li
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.
<br> OBJECTIVE:To assess the efficacy of the Enterprise stent system for the treatment of carotid artery stenosis in patients with atherosclerotic ischemic stroke.
<br> METHODS:We wil perform a single-center, double-blind, randomized paralel-controled trial at the
<br> Department of Neurology, Beijing Chao-yang Hospital, Capital Medical University, China. A cohort of 100 patients with atherosclerotic ischemic stroke wil be included after obtaining written informed consent from participantsor their guardians, and then randomly alocated 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) wil be selected for outcome observation and evaluation. The primary outcome wil be the National Institutes of Health Stroke Scale score, which is used to evaluate neurologic deficits. The secondary outcomes wil 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 wil 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).
<br> DISCUSSION:There isa lack of randomized controled 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 wil investigate and further confirm the clinical significance of the Enterprise stent system in the treatment of carotid artery stenosis in patients with ischemic stroke.
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Publication Date：2016-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：6( 5070-5075 )