Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT01289002
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2011-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
e-BioMatrix PostMarket Registry
Sponsor:
Biosensors Europe SA
Organization:
Study Overview
Official Title:
A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.
Status:
COMPLETED
Status Verified Date:
2019-05
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:
eBMX-PMR
Brief Summary:
The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.
Detailed Description:
Prospective, multi-center registry to be conducted at 60-70 international interventional cardiology centers. All patients will be followed for up to 3 years.
Study Oversight
Has Oversight DMC:
True
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?: