The purpose of this study is to evaluate the safety and effectiveness of CERENOVUS ENTERPRISE 2 intracranial stent implantation in treatment of participants with severe symptomatic intracranial atherosclerotic stenosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
194
CERENOVUS ENTERPRISE 2 Intracranial Stent will be used to treat severe symptomatic intracranial artery stenosis.
Xuanwu Hospital, Capital Medical University
Beijing, China
West China Hospital of Sichuan University
Chengdu, China
Haikou People's Hospital
Haikou, China
Percentage of Participants with In-Stent Restenosis
In-stent restenosis greater than (\>) 50 percent (%) at 12 months post-procedure as assessed by an independent Imaging Core Lab will be reported. The percent stenosis of an intracranial artery is calculated according to the warfarin-aspirin symptomatic intracranial disease (WASID) criteria: percent stenosis= (\[1-{Dstenosis/Dnormal}\]) \* 100, where Dstenosis = the diameter of the artery at the site of the most severe stenosis and Dnormal = the diameter of the proximal normal artery.
Time frame: At 12 months post-procedure
Number of Participants with Technical Success
Technical success immediately post-procedure is defined as complete stent coverage and residual stenosis less than or equal to (\<=) 50% as assessed by an independent Imaging Core Lab.
Time frame: Immediately post-procedure (Day 0)
Number of Participants with In-Stent Restenosis
In-stent restenosis (\>50%) at 6 months post-procedure as assessed by an independent Imaging Core Lab will be reported. The percent stenosis of an intracranial artery is calculated according to the warfarin-aspirin symptomatic intracranial disease (WASID) criteria: percent stenosis=(\[1-{Dstenosis/Dnormal}\]) \* 100, where Dstenosis = the diameter of the artery at the site of the most severe stenosis and Dnormal = the diameter of the proximal normal artery.
Time frame: At 6 months post-procedure
National Institutes of Health Stroke Scale (NIHSS) Scores
NIHSS scores at 6 months and 12 months post-procedure will be reported. NIHSS score is a tool used to objectively quantify the impairment caused by a stroke and to evaluate stroke severity. It ranges from 0 to 42, with 42 being the highest and 0 being the lowest. The higher the NIHSS score, the worse the neurological function.
Time frame: At 6 months and 12 months post-procedure
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First Affiliated Hospital, Harbin Medical University
Harbin, China
Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)
Jinan, China
Qilu Hospital of Shandong University
Jinan, China
Shandong Provincial Hospital
Jinan, China
Nanjing Drum Tower Hospital
Nanjing, China
Ningbo First Hospital
Ningbo, China
Huashan Hospital Fudan University
Shanghai, China
...and 4 more locations
Modified Rankin Scale (mRS) Scores
mRS scores at 30 days, 6 months and 12 months post-procedure will be reported. mRS score is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. It ranges from 0 to 5. The higher the mRS score, the worse the prognosis.
Time frame: At 30 days, 6 months and 12 months post-procedure
Number of Participants Free of Ischemic Stroke within the Territory of Stented Vessel
Ischemic stroke within the territory of stented vessel from 30 days to 12 months post-procedure as assessed by the independent clinical events committee will be reported.
Time frame: From 30 days to 12 months post-procedure