Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05391399
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2022-05-22
Brief Title:
Use of Interlocking Detachable Coils System in Embolization of Peripheral Arterial Embolization
Sponsor:
Shanghai Shenqi Medical Technology Co Ltd
Organization:
Shanghai Shenqi Medical Technology Co Ltd
Study Overview
Official Title:
A Prospective Multicenter Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of Interlocking Detachable Coils System for Embolization of Peripheral Arterial
Status:
COMPLETED
Status Verified Date:
2022-05
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 evaluate the safety and efficacy of interlocking detachable coils system in the treatment of Chinese patients with embolization of peripheral arterial in comparison with Interlock Fibered IDC Occlusion System
Detailed Description:
This is a prospective multicenter open-label non-inferiority randomized controlled clinical trial The plan is to recruit patients with peripheral arterial disease requiring embolization and then perform peripheral arterial embolization based on randomization using devices in the experimental group or control group This trail will be conducted in a number of experimental institutions in China and a total of 116 subjects are planned to be enrolled All subjects were treated with the interlocking detachable coils system and were evaluated during surgery and before discharge from the treatment of experimental or control devices followed up at 1 month 3 months and 6 months after surgery
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