Ignite Creation Date:
2024-05-05 @ 11:46 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01412164
Status:
COMPLETED
Last Update Posted:
2019-08-26
First Post:
2011-08-05
Brief Title:
Observational Registry Study FIREHAWK DES for Treating Coronary Artery Disease CAD
Sponsor:
Shanghai MicroPort Medical Group Co Ltd
Organization:
Shanghai MicroPort Medical Group Co Ltd
Study Overview
Official Title:
A Prospective Multicenter Single-Arm Observational Registry Study Assessing the Safety and Efficacy of FIREHAWK Biodegradable Polymer Target-release Rapamycin-eluting Stent for the Treatment of Coronary Artery Disease TARGET II
Status:
COMPLETED
Status Verified Date:
2019-08
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 study aims to further assess the safety efficacy and the performance of its delivery system of FIREHAWK rapamycin-eluting stent up to five years
Detailed Description:
This is a prospective open-labeled multi-center single-arm observational registry study Approximately 1100 subjects will be enrolled to evaluate the TLF as the primary endpoint at 12-month Also the study will follow up those subjects up to 5 years as the secondary endpoints
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