The purpose of this study is to verify the efficacy and safety of the Intracranial Stent (Tonbridge) in endovascular treatment of symptomatic intracranial atherosclerotic stenosis.
This is a prospective, multicenter, randomized controlled, non-inferiority clinical trial carried out in 13 centers throughout China. 200 subjects with symptomatic intracranial atherosclerotic stenosis will be treated with the Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd.) or the Wingspan Stent System (Stryker Neurovascular) for the expansion of vascular stenosis site. The primary objective of this study is to evaluate the effectiveness and safety of the intracranial stent for endovascular treatment of symptomatic intracranial atherosclerotic stenosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Endovascular treatment with Intracranial Stent (Tonbridge).
Endovascular treatment with Wingspan Stent System (Stryker Neurovascular).
The First Affiliated Hospital of Henan Science & Technology University
Luoyang, Henan, China
NOT_YET_RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Incidence of any stroke and death within 30 days
Stroke includes both ischemic and hemorrhagic stroke. Death includes death due to any cause.
Time frame: 30±7 days post-procedure
Incidence of in-stent restenosis at 6 months, 12 months, and 24 months
ISR was defined as greater than 50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and \>20% absolute luminal loss. The degree of intracranial artery stenosis will be measured qualitatively in DSA or CTA examination with WASID method.
Time frame: 6 months±60 days, 12 months±30 days, and 24 months±30 days post-procedure
Incidence of symptomatic in-stent restenosis at 6 months, 12 months, and 24 months
Symptomatic in-stent restenosis is defined as ischemic stroke or TIA or other ischemic neurological symptoms which are caused by in-stent restenosis.
Time frame: 6 months±60 days, 12 months±30 days, and 24 months±30 days post-procedure
Device success rate
Device success refers to the successful delivery of the stent to the lesion site through the delivery system during procedure, and the stent is deployed well without bending and displacement.
Time frame: intra-procedure
Procedural success rate
Procedural success is defined as stenosis degree less than 30% immediately after procedure.
Time frame: intra-procedure
Ratio of mRS 0-2 at 30 days, 6 months, 12 months, and 24 months
Subjects will be evaluated at the follow-up visits with mRS. mRS 0-2 indicates a good prognosis.
Time frame: 30±7 days, 6 months±60 days, 12 months±30 days, and 24 months±30 days post-procedure
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Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGJiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
RECRUITINGThe First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGThe First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
RECRUITINGBaotou City Central Hospital
Baotou, Neimenggu, China
RECRUITINGFirst Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
NOT_YET_RECRUITINGHangzhou First People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGNingbo First Hospital
Ningbo, Zhejiang, China
RECRUITING...and 3 more locations
Mortality at 31 days to 6 months, 6 to 12 months, and 12 to 24 months
Time frame: 31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure
Incidence of ischemic stroke in the target vessel at 31 days to 6 months, 6 to 12 months, and 12 to 24 months
Time frame: 31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure
Incidence of ischemic stroke in non-target vessel at 31 days to 6 months, 6 to 12 months, and 12 to 24 months
Time frame: 31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure
Incidence of any hemorrhagic stroke at 31 days to 6 months, 6 to 12 months, and 12 to 24 months
Time frame: 31 days to 6 months, 6 to 12 months, and 12 to 24 months post-procedure
Incidence of device deficiency
Device deficiency is the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical trials, such as labeling errors, quality problems and malfunctions. Possible device deficiency: labeling errors, product quality problems, design defects, broken sterilization packaging, etc.
Time frame: After use of device to end of study, assess up to 24 months
Incidence of adverse events (AE) at 30 days, 6 months, 12 months, and 24 months
Time frame: Through 24 months post-procedure
Incidence of serious adverse events (SAE) at 30 days, 6 months, 12 months, and 24 months
Time frame: Through 24 months post-procedure