Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346515
Status:
COMPLETED
Last Update Posted:
2008-10-21
First Post:
2006-06-29
Brief Title:
EPIC US Feasibility Study Use of the FiberNet Emboli Protection Device in Carotid Artery Stenting
Sponsor:
Lumen Biomedical
Organization:
Lumen Biomedical
Study Overview
Official Title:
Evaluating the Use of the FiberNet Emboli Protection Device in Carotid Artery Stenting The EPIC US Feasibility Study
Status:
COMPLETED
Status Verified Date:
2008-10
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:
Multicenter prospective feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical Inc FiberNet Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention using the Guidant Acculink carotid stent in high surgical risk patients
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