The purpose of this study is to verify the efficacy and safety of the Intracranial Stent (Tonbridge) in endovascular treatment of intracranial atherosclerotic stenosis.
This is a prospective, multicenter, single-arm clinical trial carried out in 14 centers throughout China. 156 subjects with intracranial atherosclerotic stenosis will be treated with the Intracranial Stent (Tonbridge) 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 intracranial atherosclerotic stenosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
156
The intracranial stent consists of a self-expanding, laser-carved nickel-titanium stent and its delivery system.
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan Science & Technology University
Luoyang, Henan, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Incidence of in-stent restenosis at 6 months
The in-stent restenosis is defined as more than 50% stenosis within stent or distal/proximal ends (within 5 mm), and more than 20% absolute lumen loss. The degree of intracranial artery stenosis are measured qualitatively in DSA examination. WASID study will be used to measure the degree of intracranial artery stenosis.
Time frame: 6 months post-procedure
Device success rate and procedural success rate
Device success refers to the successful delivery of the stent to the lesion site through the delivery system during procedure, and it is released smoothly and fits well with the vessel wall without bending and displacement; procedural success is defined as stenosis degree less than 30% immediately after procedure.
Time frame: Intraoperation
Incidence of symptomatic in-stent restenosis at 6 months, 1 year, and 2 years
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, 1 year, and 2 years post-procedure
Ratio of mRS 0-2 at 30 days, 6 months, 1 year, and 2 years
Subjects will be evaluated at the follow-up visits according to the mRS. The mRS 0-2 indicates a good prognosis.
Time frame: 30 days, 6 months, 1 year, and 2 years post-procedure
Incidence of stent restenosis at 1 and 2 years
Restenosis is defined as more than 50% stenosis within stent or distal/proximal ends (within 5 mm), and more than 20% absolute lumen loss.
Time frame: 1 and 2 years post-procedure
Incidence of any stroke and death within 30 days
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Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Baotou City Central Hospital
Baotou, Neimenggu, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
...and 4 more locations
Stroke includes both ischemic and hemorrhagic strokes. Deaths from any cause are included in this data.
Time frame: Within 30 days post-procedure
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
The 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 or life safety in the normal use of medical devices during clinical trials, such as labeling errors, quality problems, malfunctions, etc. Possible device deficiency: labeling errors, product quality problems, design defects, broken sterilization packaging, etc.
Time frame: After use of device to end of study
Incidence of adverse events (AE) at 30 days, 6 months, 1 year, and 2 years
Time frame: Through 2 years post-procedure
Incidence of serious adverse events (SAE) at 30 days, 6 months, 1 year, and 2 years
Time frame: Through 2 years post-procedure