NCT06618222

Wingspan Stent System for Intracranial Artery Stenosis

An Ambispective, Multicenter Clinical Study to Evaluate the Safety and Efficacy of the Wingspan Stent System for Clinical Use

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: The First People's Hospital of Changzhou · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Artery Stenosis
• Stent
• Endovascular Therapy

Interventions

Type	Name	Description
DEVICE	Wingspan stent system	All patients had received Percutaneous transluminal angioplasty and stenting with Wingspan stent system.

Timeline

• Start date: 2023-10-17
• Primary completion: 2025-02-10
• Completion: 2025-02-10
• First posted: 2024-10-01
• Last updated: 2025-04-23

Locations

1 site across 1 country: China