Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365697
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-09
Brief Title:
Evaluation of the Ton-bridge Carotid Stent for Carotid Artery Stenosis
Sponsor:
Zhuhai Tonbridge Medical Tech Co Ltd
Organization:
Zhuhai Tonbridge Medical Tech Co Ltd
Study Overview
Official Title:
Efficacy and Safety of the Ton-bridge Carotid Stent for the Treatment of Carotid Artery Stenosis a Prospective Multicenter Non-inferiority Randomized Controlled 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 trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis
Detailed Description:
This is a prospective multicenter open-label non-inferiority randomized controlled trial carried out in 7 research centers in China Patients with carotid atherosclerotic stenosis will be randomized 11 to either the Ton-bridge carotid stent or WALLSTENT carotid stent for treatment The purpose of this clinical trial is to evaluate the effectiveness and safety of a novel carotid stent the Ton-bridge carotid stent in humans for treatment
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None