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ACTIVE NOT RECRUITING

NCT02843633

LEADERS FREE II: BioFreedom™ Pivotal Study

Sponsor: Biosensors Europe SA

View on ClinicalTrials.gov

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.

Official title: A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

1203

Start Date

2017-02-14

Completion Date

2021-03

Last Updated

2021-02-03

Healthy Volunteers

Conditions

Acute Coronary Syndrome High Bleeding Risk

Interventions

DEVICE

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

DRUG

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

Inclusion Criteria: 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: 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: 1. Pregnant and breastfeeding women 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)

Locations (66)

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

Clinical Research Directory

LEADERS FREE II: BioFreedom™ Pivotal Study

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (66)