Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-03 @ 12:35 PM
Study NCT ID:
NCT02688868
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 )
Sponsor:
Shanghai MicroPort Medical (Group) Co., Ltd.
Organization:
Study Overview
Official Title:
The Safety and Effectiveness Evaluation of New Specifications (2.25mm) of FirehawkTM Sirolimus Target-eluting Coronary Stent System in the Treatment of Coronary Heart Disease: a Prospective, Multicenter, Single-group Study.
Status:
COMPLETED
Status Verified Date:
2020-05
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:
None
Brief Summary:
The purpose of this study is to evalute the clinical safety and effectiveness of released specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.
Detailed Description:
None
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?: