Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1203 participants
INTERVENTIONAL
2017-02-14
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BioFreedom™ Drug Coated Stent
BioFreedom™ Drug Coated Coronary Stent System
a non-surgical procedure that uses a catheter to place a stent to open up coronary arteries that have been narrowed by atherosclerosis
Antiplatelet Drug
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
Interventions
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BioFreedom™ Drug Coated Coronary Stent System
a non-surgical procedure that uses a catheter to place a stent to open up coronary arteries that have been narrowed by atherosclerosis
Antiplatelet Drug
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Reasons of unsuitability for \> 1 month dual antiplatelet treatment must include one or more of the following:
1. Adjunctive oral anticoagulation treatment planned to continue after PCI
2. Age ≥ 75 years old
3. Baseline Hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to the index procedure)
4. Any prior intracerebral bleed
5. Any stroke in the last 12 months
6. Hospital admission for bleeding during the prior 12 months
7. Non skin cancer diagnosed or treated \< 3 years, with a perceived increased risk for bleeding
8. Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or steroids for \>30 days after PCI
9. Planned surgery that would require interruption of DAPT (within next 6 months)
10. Renal failure defined as: Creatinine clearance \<40 ml/min
11. Thrombocytopenia (PLT \<100,000/mm3)
12. Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
13. Expected non-compliance to prolonged DAPT for other medical reasons
Exclusion Criteria
2. Patients expected not to comply with 1 month DAPT
3. Patients requiring a planned staged PCI procedure more than one week after the index procedure
4. Procedure planned to require non-study stents, or stand-alone plain old balloon angioplasty (POBA) or stand-alone atherectomy
5. Active bleeding at the time of inclusion
6. Reference vessel diameter \<2.25 - \>4.0mm
7. Cardiogenic shock
8. Compliance with long-term single anti-platelet therapy unlikely
9. 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
10. PCI during the previous 12 months for a lesion other than the target lesion of the index procedure
11. Participation in another clinical trial (12 months after index procedure)
12. Patients with a life expectancy of \< 12 months
13. Patients under judicial protection, tutorship or curatorship (for France only)
ALL
No
Sponsors
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Biosensors Europe SA
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Leon
Role: STUDY_CHAIR
Cardiovascular Research Foundation, New York
Mitchell Krucoff
Role: PRINCIPAL_INVESTIGATOR
Duke University
Philip Urban
Role: PRINCIPAL_INVESTIGATOR
Hôpital de la Tour
Locations
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Heart Center Research, LLC
Huntsville, Alabama, United States
Tri-Lakes Research
Hot Springs, Arkansas, United States
Scripps Health
La Jolla, California, United States
University of California San Diego
La Jolla, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida Jacksonville
Jacksonville, Florida, United States
Velella Research
Sarasota, Florida, United States
Tallahassee Research Institute, Inc.
Tallahassee, Florida, United States
North Georgia Heart Foundation
Gainesville, Georgia, United States
St. Luke's Idaho Cardiology Associates
Boise, Idaho, United States
Jesse Brown VA Medical Center
Chicago, Illinois, United States
St. Vincent Heart Center
Indianapolis, Indiana, United States
Jewish and St. Mary's Hospital
Louisville, Kentucky, United States
Lahey Clinic
Burlington, Massachusetts, United States
McLaren Bay Region
Bay City, Michigan, United States
MidMichigan Medical Center Midland
Midland, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Missouri Cardiovascular Specialists, LLP
Columbia, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
University of Buffalo
Buffalo, New York, United States
Weill Cornell Medical College-New York Presbyterian
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
Genesis Healthcare System
Zanesville, Ohio, United States
Penn State - Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Berks Cardiologists, Ltd.
Reading, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
AnMed Health
Anderson, South Carolina, United States
Black Hills Cardiovascular Research
Rapid City, South Dakota, United States
Chattanooga Heart Institute
Chattanooga, Tennessee, United States
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, United States
Houston Methodist Hospital
Houston, Texas, United States
Providence Health Center
Waco, Texas, United States
Carilion Clinic
Roanoke, Virginia, United States
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
Fraser Clinical Trials Inc.
New Westminster, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
The University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Centre Hospitalier de l'université de Montréal
Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Rigshospitalet Copenhagen University Hospital
Copenhagen, , Denmark
Clinique Axium
Aix-en-Provence, , France
Service de Cardiologie Interventionnelle - Pôle Santé République
Clermont-Ferrand, , France
Clinique de Fontaine
Fontaine-lès-Dijon, , France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, , France
Hôpital Privé Jacques Cartier ICPS
Massy, , France
Hôpital Privé Claude Galien
Quincy-sous-Sénart, , France
Clinique Saint Hilaire
Rouen, , France
CHU Toulouse Rangeuil
Toulouse, , France
Segeberger Kliniken GmbH
Bad Segeberg, , Germany
Herzzentrum Leipzig GmbH
Leipzig, , Germany
Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, , Italy
Royal Bournemouth Hospital, Dorset Heart Centre
Bournemouth, , United Kingdom
Craigavon Cardiac Centre
Craigavon, , United Kingdom
Golden Jubilee National Hospital
Glasgow, , United Kingdom
Countries
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References
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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.
Campos 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.
Mehran 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.
Other Identifiers
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16US01
Identifier Type: -
Identifier Source: org_study_id
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