Ignite Creation Date:
2024-05-05 @ 9:37 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00922337
Status:
COMPLETED
Last Update Posted:
2014-03-06
First Post:
2009-06-16
Brief Title:
The Israeli MGuard Registry
Sponsor:
InspireMD
Organization:
InspireMD
Study Overview
Official Title:
A Prospective Observational Multicenter Registry To Evaluate the Real World Clinical Performance of the MGuard Coronary Stent System
Status:
COMPLETED
Status Verified Date:
2014-03
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 Israeli MGurad Registry is to evaluate the Real World Clinical Performance of the InspireMD MGuard Coronary Stent System
Detailed Description:
A Prospective Observational Multicenter Registry The primary objective of this registry is to document the safety and overall clinical performance of the MGuard Coronary Stent System in a real world patient population requiring stent implantation
The secondary objective is to assess the event rate in patient subgroups with specific clinical indications andor vessel andor lesion characteristics
The secondary objective is to assess the event rate in patient subgroups with specific clinical indications andor vessel andor lesion characteristics
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