Ignite Creation Date:
2024-05-05 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 9:40 AM
Study NCT ID:
NCT00590356
Status:
WITHDRAWN
Last Update Posted:
2016-12-08
First Post:
2007-12-31
Brief Title:
Star-Close Versus Angio-Seal for Femoral Artery Hemostasis
Sponsor:
Seung-Jung Park
Organization:
CardioVascular Research Foundation Korea
Study Overview
Official Title:
A Randomized Comparison of Percutaneous CLip-based Vascular Occluder Star-Close Versus Bio-absorble Hemostatic Device Angio-SEal for Femoral Artery Hemostasis After Percutaneous Coronary Intervention
Status:
WITHDRAWN
Status Verified Date:
2016-12
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:
CLOSE
Brief Summary:
This study was designed to evaluate the efficacy and safety of Starclose Abbott Vascular Devices for femoral access site closure in patients undergoing PCI compared to Angio-Seal STS Plus St Jude Medical
Detailed Description:
The growing success of interventions and requirement for day case or outpatient procedures has led to a concomitant rise in the use of arteriotomy closure devices ACD to achieve hemostasis and allow early mobilization following arterial punctures ACD have emerged as an alternative to traditional mechanical compression after percutaneous coronary intervention PCI When compared to manual compression several studies have confirmed patient comfort reduced time to achieve hemostasis reduced time to ambulation and early discharge
Recently CLIP Trial was conducted to evaluated the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures A total of 17 US sites enrolled 596 subjects with 483 subjects randomized at a 21 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure The study included roll-in n113 diagnostic n208 and interventional n275 arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis This trial demonstrated that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures StarClose significantly reduced time to hemostasis ambulation and dischargeability when compared with compression
However there are no studies randomly comparing these two closure devices Therefore this study was designed to evaluate the efficacy and safety of Starclose Abbott Vascular Devices for femoral access site closure in patients undergoing PCI compared to Angio-Seal STS Plus St Jude Medical
Recently CLIP Trial was conducted to evaluated the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures A total of 17 US sites enrolled 596 subjects with 483 subjects randomized at a 21 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure The study included roll-in n113 diagnostic n208 and interventional n275 arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis This trial demonstrated that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures StarClose significantly reduced time to hemostasis ambulation and dischargeability when compared with compression
However there are no studies randomly comparing these two closure devices Therefore this study was designed to evaluate the efficacy and safety of Starclose Abbott Vascular Devices for femoral access site closure in patients undergoing PCI compared to Angio-Seal STS Plus St Jude Medical
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None