Ignite Creation Date:
2024-05-06 @ 7:23 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02520180
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2015-07-29
Brief Title:
Non-inferiority Study Comparing Firehawk Stent With Abbott Xience Family Stent TARGET-AC
Sponsor:
Shanghai MicroPort Medical Group Co Ltd
Organization:
Shanghai MicroPort Medical Group Co Ltd
Study Overview
Official Title:
A Prospective Multicenter Post Market Trial to Assess the Safety and Effectiveness of the Firehawk Rapamycin Target Eluting Cobalt Chromium Coronary Stent System Firehawk Stent System for the Treatment of Atherosclerotic Lesions
Status:
COMPLETED
Status Verified Date:
2022-12
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:
Purpose The TARGET All comers trial is a prospective multicenter randomized two-arm non-inferiority open-label study with 1656 patients at 20 centers in Europe The study is a real world all comers study
Detailed Description:
Primary objective to compare the MicroPort Medical Group Co Ltd Firehawkcobalt chromium coronary stent rapamycin target eluting system with abluminal grooves containing a biodegradable polymer with the Abbott XIENCE family EES Everolimus-Eluting stent system with respect to cardiac death myocardial infarction not clearly attributable to a non-target vessel Target Lesion Revascularization at 1 year in a real world patient population
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