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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Jishuitan Hospital
• Treatments: Aspirin; Clopidogrel; Platelet Aggregation Inhibitors

Criteria

Inclusion Criteria:

• Age >18 years

• Of either sex

• Carotid artery stenosis caused by atherosclerotic plaque

• Diagnosed with severe atherosclerotic carotid stenosis according to a previously described method (North American Symptomatic Carotid Endarterectomy Trial Collaborators, 1991)

• Severe carotid artery stenosis confirmed by transcranial Doppler and carotid duplex ultrasonography

• Provision of informed consent regarding trial procedure

Exclusion Criteria:

• Carotid artery stenosis caused by fibromuscular dysplasia, Takayasu's arteritis or radiation injury

• Severe central nervous system disorders, such as complete loss of cerebral function on the affected side with cerebral paralysis

• Life expectancy <2 years because of intracranial tumors or other diseases

• Pregnant or lactating

• Renal impairment (if use of contrast agent will worsen renal function)

• Concurrent hemorrhagic disease, or contraindication to antiplatelet or anticoagulant therapies for safety reasons

• Leakage of contrast agent indicative of vessel perforation

• Dilated aneurysm proximal or distal to stenotic foci

• Allergy to stent material

• Complete occlusion of the carotid artery or lesion length >10 mm, accompanied by intravascular thrombus and multiple segments of stenosis confirmed by imaging examination

• Intracranial hemorrhage within 3 weeks or large areas of cerebral infarction within 4 weeks of treatment

• Unable to or declined to cooperate with follow-up examination

• Unable to provide informed consent because of intellectual disability or language disorder