The primary objective of this trial is to evaluate the safety and efficacy of Wingspan Stent System in \"real world\" patients with intracranial atherosclerotic stenosis.
This study is an ambispective, multicenter clinical study design and consecutively included patients with symptomatic intracranial atherosclerotic arterial stenosis (stenosis rate of 70%-99%) with the Wingspan stent system between December 2022 and June 2023. All included patients underwent preoperative DSA to clarify the diagnosis, and were followed up within 6 months after the procedure with DSA to clarify in-stent restenosis. The main observations endpoints included revascularization within 30 days after the procedure, revascularization within 31 days to 6 months, symptomatic in-stent restenosis within 6 months after the procedure, stroke or death within 30 days or ischaemic stroke in the qualifying artery beyond 30 days through 6 months, stroke (ischaemic or hemorrhagic stroke) or death in the qualifying artery within 30 days, ischaemic stroke that occurs beyond the lesion arterial territory from 31 days to 6 months after the procedure, any cerebral parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage from 31 days to 6 months after the procedure, all-cause death (cerebrovascular death and non-cerebrovascular death) from 31 days to 6 months after the procedure.
Study Type
OBSERVATIONAL
Enrollment
43
All patients had received Percutaneous transluminal angioplasty and stenting with Wingspan stent system.
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
The incidence of In-stent restenosis within 6 months after operation
In-Stent Restenosis (ISR) is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.
Time frame: 6 months after operation
Stent success / Procedure success
Stent success is defined as Wingspan is successfully implanted into the vascular site of the target lesion with balloon pretreatment and the delivery system was successfully withdrawn. Procedure success is defined as a reduction in the degree of stenosis to ≤ 30% after the application of any interventional treatment method.
Time frame: Immediately after operative
Rate of good functional outcomes measured by Modified Rankin Score (mRS)
Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death). This outcome measured percentage of subjects with a "good"; functional outcome with a score ranging from 0-2.
Time frame: 30days, 6 months after operation
Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at 6 months follow-up
The National Institutes of Health Stroke Scale (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. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
Time frame: 6 months after operation
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Rate of all revascularization and target lesion revascularization
The proportion of patients who had revascularization in target lesion or not.
Time frame: 30days, 31days to 6 months after operation
Symptomatic ISR within 6 months
Symptomatic ISR is defined as ISR associated with ischemic event in the territory.
Time frame: within 6 months
Any stroke or death within 30 days after operation, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months after operation.
As a composite endpoint include any stroke or death within 30 days, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months after operation.
Time frame: 30days, 31days to 6 months after operation
Any stroke or death within 30 days after operation
Any stroke, death means death from any cause, including stroke or cerebrovascular disease.
Time frame: Within 30days after operation
Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel
The proportion of patients who had any stroke or died within 30 days after operation in association with stenting implantation.
Time frame: Within 30days after operation
The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months after operation
There is clear imaging evidence to confirm that the target vessel area is occluded again, which leads to ischemic stroke.
Time frame: 31days to 6 months after operation
The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months after operation
There is clear imaging evidence to confirm that outside the target vessel area is occluded again, which leads to ischemic stroke.
Time frame: 31days to 6 months after operation
Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage
There is clear imaging evidence to confirm that the incidence of any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage.
Time frame: 31days to 6 months after operation
All cause death
The proportion of patients who died from all causes is evaluated from 31 days to 6 months after operation.
Time frame: 31days to 6 months after operation