Use of the Smart nitinol stent system for the treatment of severe atherosclerotic carotid stenosis: study protocol for a retrospective non-randomized controlled trial

doi:10.3969/j.issn.2095-4344.2016.20.021

Abstract

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, parallel controlled 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-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 involving a large cohort of patients with severe atherosclerotic carotid stenosis.

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

CLC Number:

R318

Ma Zhi-gang, Sun Yu-heng, Peng Xiao-xin, Hu Hong-tao. Use of the Smart nitinol stent system for the treatment of severe atherosclerotic carotid stenosis: study protocol for a retrospective non-randomized controlled trial[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(30): 4554-4560.

References

[1] Roubin GS, New G, Iyer SS, et al. Immediate and late clinical outcomes of carotid artery stenting in patients with symptomatic and asymptomatic carotid artery stenosis: a 5-year prospective analysis. Circulation. 2001;103:532-537.
[2] Benetos A, Waeber B, Izzo J, et al. Influence of age, risk factors, and cardiovascular and renal disease on arterial stiffness: clinical applications. Am J Hypertens. 2002;15:1101-1108.
[3] Lakatta EG, Levy D. Arterial and cardiac aging: major shareholders in cardiovascular disease enterprises: Part I: aging arteries: a "set up" for vascular disease. Circulation. 2003;107:139-146.
[4] Clarkson TB. Nonhuman primate models of atherosclerosis. Lab Anim Sci. 1998;48:569-572．
[5] Craven TE, Ryu JE, Espeland MA, et al. Evaluation of the associations between carotid artery atherosclerosis and coronary artery stenosis. A case-control study. Circulation. 1990;82:1230-1242.
[6] Prabhakaran S, Rundek T, Ramas R, et al. Carotid plaque surface irregularity predicts ischemic stroke: the northern Manhattan study. Stroke. 2006;37:2696-2701.
[7] 孙玉衡,陈捷,马志刚,等.颅外动脉狭窄支架置入治疗的临床应用[J]. 中华神经科杂志, 2005, 38(1):49-50.
[8] 韩伟，叶建荣.颈动脉粥样硬化性狭窄的腔内治疗[J].实用医学杂志,2002, 18(5):295-297.
[9] 赵展,舒航,曾少建. Smart支架治疗颈动脉狭窄65例临床观察[J].实用医学杂志, 2005, 21(18):2069-2070.
[10] Phatouros CC, Higashida RT, Malek AM, et al. Endovascular stenting for carotid artery stenosis: preliminary experience using the shape-memory- alloy-recoverable-technology (SMART) stent. AJNR Am J Neuroradiol. 2000;21:732-738.
[11] Drescher R, Mathias KD, Jaeger HJ, et al. Clinical results of carotid artery stenting with a nitinol self-expanding stent (SMART stent). Eur Radiol. 2002;12:2451-2456.
[12] Wholey MH, Wholey MH, Tan WA, et al. A comparison of balloon-mounted and self-expanding stents in the carotid arteries: immediate and long-term results of more than 500 patients. J Endovasc Ther. 2003;10:171-181.
[13] Lownie SP, Pelz DM, Lee DH, et al. Efficacy of treatment of severe carotid bifurcation stenosis by using self-expanding stents without deliberate use of angioplasty balloons. AJNR Am J Neuroradiol. 2005; 26: 1241-1248.
[14] Li BM, Li S, Zhou DB, et al. Endovascular management of stenosis in carotid artery system using stent angioplasty. Medical Journal of Chinese People's Liberation Army. 2002.
[15] 陈锦华, 杨辉, 凌锋, 等.支架置入术治疗颈动脉狭窄的临床疗效[J].第三军医大学学报, 2003, 25(20):1821-1823.
[16] 高谦,彭晓新,程志远,等.支架成形术治疗颈动脉狭窄常见问题及对策的探讨[J].中国医师杂志, 2006, 8(10): 1362-1363.
[17] Noah American Symptomatic Carotid Endarterectomy Trial Collaborators. Beneficial effect of carotid endartereetomy in symptomatic patients with high-grade carotid stenosis. N Engl J Med. 1991;325:445-453．
[18] 王黎洲,周石,宋杰,等.糖尿病合并颈动脉狭窄患者血管内支架置入术疗效评估[J].中国老年学杂志，2012,32(7):1341-1343.
[19] Banks JL, Marotta CA. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials:a literature review and synthesis. Stroke. 2007;38:1091-1096.
[20] Kwah LK, Diong J. National Institutes of Health Stroke Scale (NIHSS). J Physiother. 2014;60:61.