Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309803
Status:
COMPLETED
Last Update Posted:
2008-10-21
First Post:
2006-03-30
Brief Title:
EPIC European 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 Embolic Protection Device in Carotid Artery Stenting The EPIC European 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 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 The primary endpoint is the rate of all stoke and death within 30 days of the procedure
Detailed Description:
The purpose of this feasibility study is to demonstrate the performance and safety of the Lumen Biomedical Inc FiberNet Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention The feasibility study will involve a maximum of 50 subjects to be enrolled using the FiberNet during clinically indicated percutaneous intervention of the carotid artery and followed through 30 days post procedure Subject will be enrolled in up to 5 European Investigational Sites The study is a prospective multi-center registry with sequential enrollment of qualified subjects who consent to participate and meet all entrance criteria
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