Ignite Creation Date:
2024-05-06 @ 12:35 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01600482
Status:
COMPLETED
Last Update Posted:
2017-08-23
First Post:
2012-05-16
Brief Title:
Clinical Investigation for Safety and Efficacy Study of CELT ACD Arterial ClosureDevice
Sponsor:
Vasorum Ltd
Organization:
Vasorum Ltd
Study Overview
Official Title:
Clinical Investigation Plan CIP for Safety and Efficacy Study of Arterial Closure Device CELT ACD Clinical Investigation Plan No CIP-TS-003
Status:
COMPLETED
Status Verified Date:
2017-07
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 objective of the CELT ACD Vascular Closure Device study is to evaluate the safety and effectiveness of the CELT ACD device to achieve hemostasis of the common femoral artery access site in patients on anticoagulation who are undergoing a percutaneous intervention PCI procedure using a 6F sheath
Detailed Description:
None
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