Ignite Creation Date:
2024-05-06 @ 10:35 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03307213
Status:
UNKNOWN
Last Update Posted:
2019-12-24
First Post:
2017-10-06
Brief Title:
BioFreedom QCA Study in CAD Patients
Sponsor:
Biosensors Europe SA
Organization:
Biosensors Europe SA
Study Overview
Official Title:
Evaluation of the Efficacy QCA and Safety of the BioFreedom Biolimus A9 CoCr Stent in a Randomised Trial in Patients With CAD
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
BioFreedomQCA
Brief Summary:
This study aims to demonstrate that the BioFreedom Cobalt Chromium Drug Coated Stent is non-inferior to the market authorized BioFreedom Stainless Steel Stent with respective to efficacy and shows a similar safety profile
Detailed Description:
The BioFreedom QCA trial is designed to evaluate the safety and efficacy of the BioFreedom CoCr DCS coronary stent system compared to the Biofreedom stainless steel DCS coronary stent system in a randomized controlled trial on an all-comers patient population
The primary objective is to measure non-inferiority of the BioFreedom CoCr stent compared to BioFreedom DCS as measured by the difference in angiographically measured late lumen loss at 9 months and the main secondary endpoint is to assess safety as measured by MACE and ST Two hundred 200 patients will be randomized 11 to either stent allowing for a direct comparison and will be followed-up to 2 years to measure for late MACE and ST events
The primary objective is to measure non-inferiority of the BioFreedom CoCr stent compared to BioFreedom DCS as measured by the difference in angiographically measured late lumen loss at 9 months and the main secondary endpoint is to assess safety as measured by MACE and ST Two hundred 200 patients will be randomized 11 to either stent allowing for a direct comparison and will be followed-up to 2 years to measure for late MACE and ST events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None