Ignite Creation Date:
2024-05-05 @ 10:48 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01196819
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2010-09-06
Brief Title:
Randomized MicroPorts Firehawk DES Versus Xience V TARGET I Trial
Sponsor:
Shanghai MicroPort Medical Group Co Ltd
Organization:
Shanghai MicroPort Medical Group Co Ltd
Study Overview
Official Title:
A Prospective Multi-center Randomized Trial Assessing the Safety and Effectiveness of Biodegradable Polymer Target Release Rapamycin-Eluting STent vs XIENCE V Everolimus-Eluting Stent for the Treatment of Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2019-07
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 evaluate new generation drug eluting stent DES of MicroPort of its safety efficacy and delivery system in treating CAD
Detailed Description:
The primary endpoint is in-stent late lumen loss after 9 months of the stent implantation The secondary endpoint is in-stent percent diameter stenosisThis study is based on non-inferior assumption vs Xience V requiring both endpoints reach statistical significance Prespecified OCT follow-up is planned at 3-Year after index procedure at 3 chosen hospitals
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