LEADERS FREE II: BioFreedom™ Pivotal Study
- Conditions
- High Bleeding RiskAcute Coronary Syndrome
- Interventions
- Device: BioFreedom™ Drug Coated Coronary Stent SystemDrug: Antiplatelet Drug
- Registration Number
- NCT02843633
- Lead Sponsor
- Biosensors Europe SA
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1203
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
- 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
- Active bleeding at the time of inclusion
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BioFreedom™ Drug Coated Stent BioFreedom™ Drug Coated Coronary Stent System - BioFreedom™ Drug Coated Stent Antiplatelet Drug -
- Primary Outcome Measures
Name Time Method The incidence of clinically driven target lesion revascularization at twelve months 12 months The composite of cardiac death and myocardial infarction at twelve months 12 months
- Secondary Outcome Measures
Name Time Method Clinically driven target lesion revascularization at time points other than primary endpoint followed for all target lesion revascularizations, up to 3 years Urgent target lesion revascularization 1, 2, and 6 months and 1, 2, and 3 years 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 Clinically driven target vessel revascularization 1, 2, and 6 months and 1, 2, and 3 years Primary endpoints, in patients with at least 1 lesion treated with a trial stent of 3mm or less in nominal diameter 1, 2, and 6 months and 1, 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 Myocardial Infarction 1, 2, and 6 months and 1, 2, and 3 years Stent Thrombosis per Academic Research Consortium (ARC) Definition 1, 2, and 6 months and 1, 2, and 3 years All cause mortality 1, 2, and 6 months and 1, 2, and 3 years
Trial Locations
- Locations (66)
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Tennova Healthcare-Turkey Creek Medical Center
🇺🇸Knoxville, Tennessee, United States
Velella Research
🇺🇸Sarasota, Florida, United States
Jewish and St. Mary's Hospital
🇺🇸Louisville, Kentucky, United States
Hôpital Maisonneuve-Rosemont
🇨🇦Montréal, Quebec, Canada
MidMichigan Medical Center Midland
🇺🇸Midland, Michigan, United States
Berks Cardiologists, Ltd.
🇺🇸Reading, Pennsylvania, United States
University of Buffalo
🇺🇸Buffalo, New York, United States
Institut universitaire de cardiologie et de pneumologie de Québec
🇨🇦Québec, Quebec, Canada
Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States
Clinique Axium
🇫🇷Aix-en-Provence, France
Scripps Health
🇺🇸La Jolla, California, United States
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Germany
Craigavon Cardiac Centre
🇬🇧Craigavon, United Kingdom
Tri-Lakes Research
🇺🇸Hot Springs, Arkansas, United States
Royal Bournemouth Hospital, Dorset Heart Centre
🇬🇧Bournemouth, United Kingdom
Hôpital Privé Jacques Cartier ICPS
🇫🇷Massy, France
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Missouri Cardiovascular Specialists, LLP
🇺🇸Columbia, Missouri, United States
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Novant Health Heart and Vascular Institute
🇺🇸Charlotte, North Carolina, United States
Service de Cardiologie Interventionnelle - Pôle Santé République
🇫🇷Clermont-Ferrand, France
Montreal Heart Institute
🇨🇦Montréal, Quebec, Canada
NC Heart and Vascular Research
🇺🇸Raleigh, North Carolina, United States
AnMed Health
🇺🇸Anderson, South Carolina, United States
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
Grande Ospedale Metropolitano Niguarda
🇮🇹Milan, Italy
Centre Hospitalier de l'université de Montréal
🇨🇦Montréal, Quebec, Canada
Clinique de Fontaine
🇫🇷Fontaine-lès-Dijon, France
Groupe Hospitalier Mutualiste de Grenoble
🇫🇷Grenoble, France
St. Vincent Heart Center
🇺🇸Indianapolis, Indiana, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Rigshospitalet Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
North Georgia Heart Foundation
🇺🇸Gainesville, Georgia, United States
Tallahassee Research Institute, Inc.
🇺🇸Tallahassee, Florida, United States
McLaren Bay Region
🇺🇸Bay City, Michigan, United States
Weill Cornell Medical College-New York Presbyterian
🇺🇸New York, New York, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Columbia University Medical Center/New York Presbyterian Hospital
🇺🇸New York, New York, United States
LeBauer Cardiovascular Research Foundation
🇺🇸Greensboro, North Carolina, United States
Penn State - Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Providence Health Center
🇺🇸Waco, Texas, United States
Black Hills Cardiovascular Research
🇺🇸Rapid City, South Dakota, United States
Victoria Heart Institute Foundation
🇨🇦Victoria, British Columbia, Canada
Fraser Clinical Trials Inc.
🇨🇦New Westminster, British Columbia, Canada
Mazankowski Alberta Heart Institute
🇨🇦Edmonton, Alberta, Canada
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Hôpital Privé Claude Galien
🇫🇷Quincy-sous-Sénart, France
Segeberger Kliniken GmbH
🇩🇪Bad Segeberg, Germany
Clinique Saint Hilaire
🇫🇷Rouen, France
CHU Toulouse Rangeuil
🇫🇷Toulouse, France
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Rome, Italy
Golden Jubilee National Hospital
🇬🇧Glasgow, United Kingdom
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
St. Luke's Idaho Cardiology Associates
🇺🇸Boise, Idaho, United States
University of Florida Jacksonville
🇺🇸Jacksonville, Florida, United States
Jesse Brown VA Medical Center
🇺🇸Chicago, Illinois, United States
Genesis Healthcare System
🇺🇸Zanesville, Ohio, United States
The University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Pinnacle Health Cardiovascular Institute
🇺🇸Wormleysburg, Pennsylvania, United States
Chattanooga Heart Institute
🇺🇸Chattanooga, Tennessee, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States