An Ambispective, Multicenter Clinical Study to Evaluate the Safety and Efficacy of the Wingspan Stent System for Clinical Use
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Artery Stenosis
- Sponsor
- The First People's Hospital of Changzhou
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- The incidence of In-stent restenosis within 6 months after operation
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •30 to 80 years of age;
- •Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery;
- •Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery;
- •The target lesion was in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, and it was a single lesion that required surgical treatment;
- •The patient voluntarily underwent treatment with the Wingspan stent system;
- •mRS \< 3 (if any);
- •The onset of the latest transient ischemic attack (TIA) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure;
- •Willingness to participate in this clinical trial and signing the consent form, and be able to complete the corresponding inspections, follow ups, etc. according to the requirements of the clinical protocol during the clinical trial.
Exclusion Criteria
- •The target vessels was complete occlusion;
- •\>70% stenosis observed at the intracranial large-vessel distal to the target vessel or \>70% stenosis observed at the intracranial/extracranial large-vessel proximal to the target vessel;
- •Preoperative magnetic resonance showed perforating infarction in the target lesion area;
- •Preoperative CT showed that there was hemorrhage transformation after infarction in the target vessel area, or a history of primary cerebral hemorrhage, or a history of subarachnoid, subdural and epidural hemorrhage within 30 days before operation, or there was no treatment Chronic subdural hematoma ≥5mm;
- •Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery;
- •CT showed Severe calcified lesions;
- •Previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation);
- •Non-atherosclerosis lesions;
- •Patients with potential sources of cardiac embolism (such as atrial fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks);
- •Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;
Outcomes
Primary Outcomes
The incidence of In-stent restenosis within 6 months after operation
Time Frame: 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.
Secondary Outcomes
- Stent success / Procedure success(Immediately after operative)
- Rate of good functional outcomes measured by Modified Rankin Score (mRS)(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(6 months after operation)
- Rate of all revascularization and target lesion revascularization(30days, 31days to 6 months after operation)
- Symptomatic ISR within 6 months(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.(30days, 31days to 6 months after operation)
- Any stroke or death within 30 days after operation(Within 30days after operation)
- Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel(Within 30days after operation)
- The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months after operation(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(31days to 6 months after operation)
- Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage(31days to 6 months after operation)
- All cause death(31days to 6 months after operation)