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LEADERS FREE II: BioFreedom™ Pivotal Study

StatusActive, Not Recruiting
PhaseNot applicable
Started2017-02-14
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 23 times since 2016-07-21; most recent filed 2021-09-14. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-09-15.

2021-09-14
Amendment Study Status, Outcome Measures, Outcome Measures (Results) v23
2021-08-03
Amendment Active, Not RecruitingCompleted Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v22
2021-02-01
Amendment Study Status v21
2020-08-17
Amendment Study Status v20
2020-02-07
Amendment Study Status, Study Description v19
2020-01-23
Amendment Study Status, Arms and Interventions v18
2019-06-05
Amendment Study Status, Study Design v17
2019-01-14
Amendment Study Status v16
2018-04-03
Amendment Study Status v15
2018-03-15
Amendment Study Status, Contacts/Locations v14
2017-09-05
Amendment RecruitingActive, Not Recruiting Study Status, Contacts/Locations v13
2017-08-27
Amendment Study Status, Contacts/Locations v12
2017-07-31
Amendment Study Status, Contacts/Locations v11
2017-06-25
Amendment Study Status, Contacts/Locations v10
2017-05-22
Amendment Study Status, Contacts/Locations v9
2017-05-03
Amendment Study Status, Contacts/Locations v8
2017-04-03
Amendment Study Status, Contacts/Locations v7
2017-02-28
Amendment Study Status, Outcome Measures v6
2017-02-20
Amendment Not Yet RecruitingRecruiting Study Status, Oversight, Outcome Measures, Contacts/Locations v5
2017-01-05
Amendment WithheldNot Yet Recruiting Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, IPDSharing, References v4
2016-12-21
Amendment Study Status v3
2016-08-03
Amendment Study Status v2
2016-07-28
Amendment Study Status v1
2016-07-21
Original filing
Trial Details
NCT Number NCT02843633
Lead Sponsor Biosensors Europe SA
Conditions Acute Coronary Syndrome, High Bleeding Risk
Enrollment 1,203 participants
Start Date 2017-02-14
Primary Completion 2018-10-11 (estimated)
Study Completion 2021-03 (estimated)
Updated on ClinicalTrials.gov 2021-02-03