Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657326
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-23
Brief Title:
LEADERS FREE IV RCT BioFreedom Ultra vs BioFreedom in HBR Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Efficacy QCA and Safety of the BioFreedom Ultra Drug Coated Stent in Patients With High Bleeding Risk and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to demonstrate that the BioFreedom Ultra Drug Coated Stent DCS is non-inferior to the BioFreedom DCS with respect to in-stent late lumen loss and that it has safety characteristics similar to the BioFreedom DCS
Detailed Description:
The LEADERS FREE IV trial is conducted to evaluate of the efficacy QCA and safety of the BioFreedom Ultra Drug Coated Stent in patients with High Bleeding Risk HBR and coronary artery disease undergoing Percutaneous Coronary Intervention
It is a prospective multi-center single blind to patient randomized comparator trial designed to randomize 444 HBR patients at approximately up to 7 centers in Malaysia
The primary objective is to confirm non-inferiority of the BioFreedom Ultra stent compared to BioFreedom DCS as measured by the difference in angiographically measured late lumen loss at 9 months and the main secondary objective is to assess safety as measured by TLF and ST 444 patients will be randomized 11 to either stent allowing for a direct comparison and will be followed up to 5 years to measure for late TLF and ST events
It is a prospective multi-center single blind to patient randomized comparator trial designed to randomize 444 HBR patients at approximately up to 7 centers in Malaysia
The primary objective is to confirm non-inferiority of the BioFreedom Ultra stent compared to BioFreedom DCS as measured by the difference in angiographically measured late lumen loss at 9 months and the main secondary objective is to assess safety as measured by TLF and ST 444 patients will be randomized 11 to either stent allowing for a direct comparison and will be followed up to 5 years to measure for late TLF and ST events
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