Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05841836
Status:
RECRUITING
Last Update Posted:
2023-05-03
First Post:
2023-03-31
Brief Title:
The Safety and Efficacy of the Suture-Mediated Closure System
Sponsor:
Zhejiang Zylox Medical Device Co Ltd
Organization:
Zhejiang Zylox Medical Device Co Ltd
Study Overview
Official Title:
A Prospective Multi-center Randomized Controlled Non-inferiority Clinical Trial of the Safety and Efficacy of the Suture-Mediated Closure System for Percutaneous Closure of the Common Femoral Artery Puncture Site
Status:
RECRUITING
Status Verified Date:
2023-04
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:
This was a prospective multicenter randomized controlled non-inferiority clinical study with the primary objective of validating the safety and efficacy of the Suture-Mediated Closure System for percutaneous closure of the common femoral artery puncture site
Detailed Description:
This study was a prospective multicenter randomized controlled non-inferiority clinical trial It is planned to be conducted in multiple clinical trial institutions and enroll 228 subjects Eligible subjects were randomly divided into the experimental group or the control group at a ratio of 11
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