| STUDY PROTOCOL |
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| Year : 2016 | Volume
: 1
| Issue : 2 | Page : 64-70 |
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Use of the Smart nitinol stent system for the treatment of severe atherosclerotic carotid stenosis: study protocol for a retrospective, non-randomized, long-term parallel controlled trial
Zhi-gang Ma, Yu-heng Sun, Xiao-xin Peng, Hong-tao Hu
Department of Neurology, Beijing Jishuitan Hospital, Beijing, China
Correspondence Address:
Zhi-gang Ma
Department of Neurology, Beijing Jishuitan Hospital, Beijing
China
 Source of Support: This study was supported by Capital Medical Development Research Foundation, China, No. 2003-1002, Conflict of Interest: None  | Check |
DOI: 10.4103/2468-5658.184746
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Background: The carotid artery should be stented in patients with 70-90% stenosis owing to the high risk of stroke. 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.
Methods/Design: We conducted a retrospective, single-center, non-randomized, parallel controlled trial at Beijing Jishuitan Hospital, China. A cohort of 103 patients with severe atherosclerotic carotid stenosis was included in the analysis. 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 and dependence 2 years after treatment, assessed by the modified Rankin Scale (mRS). The secondary outcomes are mRS score 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.
Discussion: Previous studies of the Smart nitinol stent system for the treatment of carotid stenosis are mostly self-controlled case series or small cohort studies with short follow-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 illuminates the therapeutic benefits of the Smart nitinol stent system in a 2-year follow-up study of a large cohort of patients with severe atherosclerotic carotid stenosis.
Trial registration: This trial was registered at ClinicalTrial.gov (NCT02800174).
Ethics: 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.
Informed consent: Written informed consent was obtained from participants or their guardians. |
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