Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT05757505
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2023-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
Sponsor:
Ton-Bridge Medical Tech. Co., Ltd
Organization:
Study Overview
Official Title:
The Efficacy and Safety of the Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis: a Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to verify the efficacy and safety of the Intracranial Stent (Tonbridge) in endovascular treatment of symptomatic intracranial atherosclerotic stenosis.
Detailed Description:
This is a prospective, multicenter, randomized controlled, non-inferiority clinical trial carried out in 13 centers throughout China. 200 subjects with symptomatic intracranial atherosclerotic stenosis will be treated with the Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd.) or the Wingspan Stent System (Stryker Neurovascular) for the expansion of vascular stenosis site. The primary objective of this study is to evaluate the effectiveness and safety of the intracranial stent for endovascular treatment of symptomatic intracranial atherosclerotic stenosis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: