Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618222
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Wingspan Stent System for Intracranial Artery Stenosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Ambispective Multicenter Clinical Study to Evaluate the Safety and Efficacy of the Wingspan Stent System for Clinical Use
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this trial is to evaluate the safety and efficacy of Wingspan Stent System in 34real world34 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None