Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wingspan stent | All patients had received Percutaneous transluminal angioplasty and stenting with Wingspan stent system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wingspan stent system | Device | All patients had received Percutaneous transluminal angioplasty and stenting with Wingspan stent system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after operative |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
symptomatic ICAS (stenosis rate of 70%-99%) with the Wingspan stent system between December 2022 and June 2023
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ya Deng | The First People's Hospital of Changzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First People's Hospital of Changzhou | Changzhou | Jiangsu | China |
Not provided
Not provided
Not provided
Not provided
| 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. | 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). | 6 months after operation |
| Rate of all revascularization and target lesion revascularization | The proportion of patients who had revascularization in target lesion or not. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 31days to 6 months after operation |