Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-02-22 @ 3:50 PM
Study NCT ID:
NCT02843633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-02-03
First Post:
2016-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LEADERS FREE II: BioFreedom™ Pivotal Study
Sponsor:
Biosensors Europe SA
Organization:
Study Overview
Official Title:
A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2021-02
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:
This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.
Detailed Description:
In this study all patients will receive the BioFreedom™ Drug Coated Stent and one month of Dual Anti Platelet Therapy
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: