Clinical Trial: Smart Nitinol Stent System for the Treatment of Severe Atherosclerotic Carotid Stenosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief Summary: To validate the long-term effects of implantation of the self-expanding Smart nitinol stent system for the treatment of severe atherosclerotic carotid stenosis in a 2-year follow-up study of a large patient cohort

Detailed Summary:

Atherosclerosis is a leading cause of carotid artery stenosis. The risk of atherosclerosis increases with age, occurring mainly in middle-aged and elderly populations. The morbidity and mortality of stroke caused by atherosclerosis also increase with aging. An epidemiologic study demonstrated that carotid artery intima-media thickness is a marker of atherosclerotic peripheral arterial disease, and found evidence that the likelihood of a clinical diagnosis of atherosclerosis increases two- to threefold from 20 to 90 years of age. The risk of atherosclerosis also increases with age in animals fed atherosclerosis-inducing diets. The close relationship between atherosclerosis and aging shows that atherosclerosis is a chronic and progressive degenerative disease.

Atherosclerotic carotid stenosis is an independent risk factor for ischemic cerebrovascular disease. Vascular stenting of carotid artery stenosis is an increasingly popular technique. It is safe, quick, minimally invasive, can be performed under local anesthesia, and can be used to treat proximal and intracranial lesions. Vascular stenting enables flow to be restored in previously narrowed vessels, restoring blood supply to the brain and preventing plaque rupture. Carotid artery stenosis of 70%-90% is considered the highest risk for stroke, and is a compelling indication for stenting. The Smart stent system (Cordis Corporation, Miami, FL, USA) is a nitinol self-expanding stent that is soft, elastic, has uniform radial tension and is readily endothelialized.

Phatouros et al. treated four patients with carotid artery stenosis >70% using self-expanding Smart stents and <20% residual stenosis was achieved in all cases; no transient ischemic attacks or new strokes occurred during a follow up period of 6 months. Drescher et al. also used self-expanding Smart stents in
Sponsor: Beijing Jishuitan Hospital

Current Primary Outcome: mRS score [ Time Frame: 2 years after treatment ]

The mRS is a 7-point scale used to evaluate a patient's functional recovery.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The recurrence of cerebrovascular events [ Time Frame: 1 and 2 years after treatment ]
    The incidences of transient cerebral ischemia, cerebral infarction, cerebral hemorrhage or death because of cerebrovascular diseases will be recorded.
  • National Institute of Health stroke scale(NIHSS) score [ Time Frame: 1 and 2 years after treatment ]
    The NIHSS is a 43-point scale, with higher scores indicative of more severe neurological deficits.


Original Secondary Outcome: Same as current

Information By: Beijing Jishuitan Hospital

Dates:
Date Received: June 12, 2016
Date Started: June 2006
Date Completion:
Last Updated: June 12, 2016
Last Verified: June 2016