LEADERS FREE II: BioFreedom™ Pivotal Study
A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding
1 other identifier
interventional
1,203
7 countries
66
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedStudy Start
First participant enrolled
February 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedFebruary 3, 2021
February 1, 2021
1.7 years
July 15, 2016
February 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The composite of cardiac death and myocardial infarction at twelve months
12 months
The incidence of clinically driven target lesion revascularization at twelve months
12 months
Secondary Outcomes (12)
The composite of cardiac death and myocardial infarction
1, 2, and 6 months and 2 and 3 years
The incidence of clinically driven target lesion revascularization
1, 2, and 6 months and 2 and 3 years
The composite of cardiac death, myocardial infarction and stent thrombosis
1, 2, and 6 months and 1, 2, and 3 years
Bleeding per Bleeding Academic Research Consortium (BARC) Criteria
1, 2, and 6 months and 1, 2, and 3 years
Cardiac Death
1, 2, and 6 months and 1, 2, and 3 years
- +7 more secondary outcomes
Study Arms (1)
BioFreedom™ Drug Coated Stent
EXPERIMENTALInterventions
a non-surgical procedure that uses a catheter to place a stent to open up coronary arteries that have been narrowed by atherosclerosis
Dual antiplatelet therapy for one month followed by single antiplatelet therapy indefinitely. Aspirin and clopidogrel (or other P2Y12 inhibitor) will be used and dosing is according to standard institutional practice
Eligibility Criteria
You may qualify if:
- Any indication for percutaneous coronary intervention with stent placement (PCI-S) in patients deemed at high risk for bleeding and candidates for 1 month dual anti-platelet therapy (DAPT). This includes candidates with stable angina, silent ischemia, acute coronary syndrome (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.
- Reasons of unsuitability for \> 1 month dual antiplatelet treatment must include one or more of the following:
- Adjunctive oral anticoagulation treatment planned to continue after PCI
- Age ≥ 75 years old
- Baseline Hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to the index procedure)
- Any prior intracerebral bleed
- Any stroke in the last 12 months
- Hospital admission for bleeding during the prior 12 months
- Non skin cancer diagnosed or treated \< 3 years, with a perceived increased risk for bleeding
- Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or steroids for \>30 days after PCI
- Planned surgery that would require interruption of DAPT (within next 6 months)
- Renal failure defined as: Creatinine clearance \<40 ml/min
- Thrombocytopenia (PLT \<100,000/mm3)
- Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
- Expected non-compliance to prolonged DAPT for other medical reasons
You may not qualify if:
- Pregnant and breastfeeding women
- Patients expected not to comply with 1 month DAPT
- Patients requiring a planned staged PCI procedure more than one week after the index procedure
- Procedure planned to require non-study stents, or stand-alone plain old balloon angioplasty (POBA) or stand-alone atherectomy
- Reference vessel diameter \<2.25 - \>4.0mm
- Cardiogenic shock
- Compliance with long-term single anti-platelet therapy unlikely
- A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated
- PCI during the previous 12 months for a lesion other than the target lesion of the index procedure
- Participation in another clinical trial (12 months after index procedure)
- Patients with a life expectancy of \< 12 months
- Patients under judicial protection, tutorship or curatorship (for France only)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Tri-Lakes Research
Hot Springs, Arkansas, 71901, United States
Scripps Health
La Jolla, California, 92037, United States
University of California San Diego
La Jolla, California, 92037, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93102, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida Jacksonville
Jacksonville, Florida, 32209, United States
Velella Research
Sarasota, Florida, 34239, United States
Tallahassee Research Institute, Inc.
Tallahassee, Florida, 32308, United States
North Georgia Heart Foundation
Gainesville, Georgia, 30501, United States
St. Luke's Idaho Cardiology Associates
Boise, Idaho, 83712, United States
Jesse Brown VA Medical Center
Chicago, Illinois, 60612, United States
St. Vincent Heart Center
Indianapolis, Indiana, 46290, United States
Jewish and St. Mary's Hospital
Louisville, Kentucky, 40202, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
McLaren Bay Region
Bay City, Michigan, 48708, United States
MidMichigan Medical Center Midland
Midland, Michigan, 48670, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Missouri Cardiovascular Specialists, LLP
Columbia, Missouri, 65201, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
University of Buffalo
Buffalo, New York, 14203, United States
Weill Cornell Medical College-New York Presbyterian
New York, New York, 10021, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032, United States
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401, United States
NC Heart and Vascular Research
Raleigh, North Carolina, 27607, United States
Genesis Healthcare System
Zanesville, Ohio, 43701, United States
Penn State - Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Berks Cardiologists, Ltd.
Reading, Pennsylvania, 19610, United States
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, 17043, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
AnMed Health
Anderson, South Carolina, 29621, United States
Black Hills Cardiovascular Research
Rapid City, South Dakota, 57701, United States
Chattanooga Heart Institute
Chattanooga, Tennessee, 37404, United States
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Providence Health Center
Waco, Texas, 76712, United States
Carilion Clinic
Roanoke, Virginia, 24014, United States
Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G 2B7, Canada
Fraser Clinical Trials Inc.
New Westminster, British Columbia, V3L 3W4, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6E 1M7, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 4R2, Canada
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2, Canada
The University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Centre Hospitalier de l'université de Montréal
Montreal, Quebec, H2W 1T8, Canada
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5, Canada
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Rigshospitalet Copenhagen University Hospital
Copenhagen, 2100, Denmark
Clinique Axium
Aix-en-Provence, 13097, France
Service de Cardiologie Interventionnelle - Pôle Santé République
Clermont-Ferrand, 63050, France
Clinique de Fontaine
Fontaine-lès-Dijon, 21121, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38000, France
Hôpital Privé Jacques Cartier ICPS
Massy, 91300, France
Hôpital Privé Claude Galien
Quincy-sous-Sénart, 91480, France
Clinique Saint Hilaire
Rouen, 76000, France
CHU Toulouse Rangeuil
Toulouse, France
Segeberger Kliniken GmbH
Bad Segeberg, Germany
Herzzentrum Leipzig GmbH
Leipzig, 04289, Germany
Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, 00152, Italy
Royal Bournemouth Hospital, Dorset Heart Centre
Bournemouth, United Kingdom
Craigavon Cardiac Centre
Craigavon, BT63 5QQ, United Kingdom
Golden Jubilee National Hospital
Glasgow, G81 4DY, United Kingdom
Related Publications (3)
Eberli FR, Oldroyd KG, Urban P, Krucoff MW, Morice MC, Tanguay JF, Leon MB, Brunel P, Maillard L, Lipiecki J, Cook S, Berland J, Hovasse T, Carrie D, Schutte D, Sadozai Slama S, Garot P. Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years. Open Heart. 2024 Jun 18;11(1):e002679. doi: 10.1136/openhrt-2024-002679.
PMID: 38890129DERIVEDCampos CM, Mehran R, Capodanno D, Owen R, Windecker S, Varenne O, Stone GW, Valgimigli M, Hajjar LA, Kalil Filho R, Oldroyd K, Morice MC, Urban P, Abizaid A. Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials. Circ Cardiovasc Interv. 2024 Apr;17(4):e013000. doi: 10.1161/CIRCINTERVENTIONS.122.013000. Epub 2024 Apr 16.
PMID: 38626080DERIVEDMehran R, Chandrasekhar J, Urban P, Lang IM, Windhoevel U, Spaulding C, Copt S, Stoll HP, Morice MC; LEADERS FREE Investigators. Sex-Based Outcomes in Patients With a High Bleeding Risk After Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy: A Secondary Analysis of the LEADERS FREE Randomized Clinical Trial. JAMA Cardiol. 2020 Aug 1;5(8):939-947. doi: 10.1001/jamacardio.2020.0285.
PMID: 32432718DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Martin Leon
Cardiovascular Research Foundation, New York
- PRINCIPAL INVESTIGATOR
Mitchell Krucoff
Duke University
- PRINCIPAL INVESTIGATOR
Philip Urban
Hôpital de la Tour
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2016
First Posted
July 26, 2016
Study Start
February 14, 2017
Primary Completion
October 11, 2018
Study Completion
March 1, 2021
Last Updated
February 3, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
The emphasis in all scientific publications and presentations will be placed on the 1-year endpoint