To study the clinical outcomes after implantation of balloon-expandable drug-eluting stents in patients with symptomatic intracranial atherosclerotic stenosis in prevention of composite event of any stroke and death within 30 days and ischemic stroke in the territories of the responsible artery from 31 days to 1-year.
This study is a prospective, multi-center, real world, registry study. This study aimed to evaluate the effectiveness of balloon-expandable drug-eluting stents in treating stenosis in the C2-C7 segments of the internal carotid artery and V4 artery which with high prevalence of calcified plaques in ICAD.
Study Type
OBSERVATIONAL
Enrollment
520
Balloon-expandable drug-eluting stent (BDES) is the device comprises of a balloon expandable sirolimus eluting stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.
Any stroke or death within 30 days of implantation or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year.
Primary endpoints are composite event of (1) any stroke or death within 30 days after enrollment, (2) any stroke or death within 30 days after revascularization procedure of the qualifying lesion during follow-up, and (3) ischemic stroke in the territory of the qualifying artery from 31 days to 1 year.
Time frame: 12 months after implantation
Any cerebral events within 1 year
Cerebral events defined as transient ischemic attack (TIA), ischemic stroke, thrombus and death in the territory of the qualifying artery
Time frame: 12 months after implantation
Periprocedural events
Periprocedural events defined as transient ischemic attack (TIA), ischemic stroke and all-cause death.
Time frame: within 30 days after implantation
In-stent restenosis(ISR) rate
The ISR is defined as \>50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and \>20% absolute luminal loss on angiographic experiment.
Time frame: 12 months after implantation
Technique success rate
Technique success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system with a residual stenosis of \<30%.
Time frame: During the procedure
Functional outcome measured by modified Rankin Scale and NIH stroke scale (NIHSS) score
Modified Rankin Scale (mRS) score and NIHSS score(if need) at every year after implantation during 5 years. The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead. A higher score indicates a worse outcome. NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The minimum score is 1 and the maximum score is 20. A higher score indicates a worse outcome.
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Time frame: Every year after implantation during 5 years