Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05334095
Status:
UNKNOWN
Last Update Posted:
2022-04-19
First Post:
2022-04-06
Brief Title:
Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease
Sponsor:
Xiongjing Jiang
Organization:
Chinese Academy of Medical Sciences Fuwai Hospital
Study Overview
Official Title:
Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease a Prospective Single-center Randomized Non-inferiority Trial
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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 study is designed to evaluate the efficacy device deployment characteristics and performance and safety adverse access site related events of Perclose ProGlide Abbott Vascular Devices for femoral access site closure in patients undergoing peripheral vascular diagnostic and interventional procedures in comparison with Angio-seal VIP St Jude Medical
Detailed Description:
Prospective single-center randomized 11 open-label non-inferiority study in 1062 patients comparing Perclose ProGlide test device to the Angio-seal VIP standard comparator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None