Use of the Smart nitinol stent system for the treatment of severe atherosclerotic carotid stenosis:study protocol for a retrospective non-randomized controlled trial
10.3969/j.issn.2095-4344.2016.20.021
- VernacularTitle:镍钛Smart支架系统治疗重度动脉粥样硬化性颈动脉狭窄：回顾性非随机对照临床试验方案
- Author:
Zhigang MA
;
Yuheng SUN
;
Xiaoxin PENG
;
Hongtao HU
- Publication Type:Journal Article
- From:
Chinese Journal of Tissue Engineering Research
2016;20(30):4554-4560
- CountryChina
- Language:Chinese
-
Abstract:
BACKGROUND:The self-expanding Smart nitinol stent system is a popular treatment for carotid artery stenosis, because it is easy to manipulate and deploy, and endothelialization is rapid. OBJECTIVE:To assess the efficacy of Smart nitinol stent system for the treatment of severe atherosclerotic carotid stenosis. METHODS:We conducted a retrospective, single-center, non-randomized, paral el control ed trial. A cohort of 103 patients with severe atherosclerotic carotid stenosis was included in the analysis after obtaining written informed consent from participants or their guardians. Treatment was undertaken according to each patient’s wishes after weighing the options:a Smart nitinol stent system (Cordis Corporation, Miami, FL, USA) was used in 40 patients, while 63 were managed conservatively with antiplatelet drugs. The primary outcome is the degree of disability of dependence 2 years after treatment, assessed by the modified Rankin Scale. The secondary outcomes are mRS scores 90 days and 1 year after treatment, recurrence of cerebrovascular events, and severity of neurologic deficit measured using the National Institutes of Health Stroke Scale 1 and 2 years after treatment. The study protocol was approved by the Ethics Committee of Beijing Jishuitan Hospital, China (approval number:201605-01) and conducted in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. This trial was registered at ClinicalTrial.gov (NCT02800174). DISCUSSION:Previous studies of the Smart nitinol stent system for the treatment of carotid stenosis are mostly self-control ed case series or smal cohort studies with short fol ow-up periods. Consequently, the long-term influence of Smart nitinol stent deployment on the risk of cerebrovascular events and long-term outcomes are not known. This trial il uminates the therapeutic benefits of the Smart nitinol stent system in a 2-year fol ow-up study involving a large cohort of patients with severe atherosclerotic carotid stenosis.
