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LEADERS FREE II: BioFreedom™ Pivotal Study

Sponsor
Biosensors Europe SA (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02843633
Collaborator
(none)
1,203
Enrollment
66
Locations
1
Arm
48.5
Anticipated Duration (Months)
18.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: BioFreedom™ Drug Coated Coronary Stent System
  • Drug: Antiplatelet Drug
 N/A

Detailed Description

In this study all patients will receive the BioFreedom™ Drug Coated Stent and one month of Dual Anti Platelet Therapy

Study Design

Study Type:
Interventional
Actual Enrollment :
1203 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding
Actual Study Start Date :
Feb 14, 2017
Actual Primary Completion Date :
Oct 11, 2018
Anticipated Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: BioFreedom™ Drug Coated Stent

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
Other Names:
  • Coronary Angioplasty

    • 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

    Outcome Measures

    Primary Outcome Measures

    1. The composite of cardiac death and myocardial infarction at twelve months [12 months]

    2. The incidence of clinically driven target lesion revascularization at twelve months [12 months]

    Secondary Outcome Measures

    1. The composite of cardiac death and myocardial infarction [1, 2, and 6 months and 2 and 3 years]

    2. The incidence of clinically driven target lesion revascularization [1, 2, and 6 months and 2 and 3 years]

    3. The composite of cardiac death, myocardial infarction and stent thrombosis [1, 2, and 6 months and 1, 2, and 3 years]

    4. Bleeding per Bleeding Academic Research Consortium (BARC) Criteria [1, 2, and 6 months and 1, 2, and 3 years]

    5. Cardiac Death [1, 2, and 6 months and 1, 2, and 3 years]

    6. Myocardial Infarction [1, 2, and 6 months and 1, 2, and 3 years]

    7. Stent Thrombosis per Academic Research Consortium (ARC) Definition [1, 2, and 6 months and 1, 2, and 3 years]

    8. Urgent target lesion revascularization [1, 2, and 6 months and 1, 2, and 3 years]

    9. Clinically driven target lesion revascularization at time points other than primary endpoint [followed for all target lesion revascularizations, up to 3 years]

    10. Clinically driven target vessel revascularization [1, 2, and 6 months and 1, 2, and 3 years]

    11. All cause mortality [1, 2, and 6 months and 1, 2, and 3 years]

    12. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heart Center Research, LLC Huntsville Alabama United States 35801
    2 Tri-Lakes Research Hot Springs Arkansas United States 71901
    3 Scripps Health La Jolla California United States 92037
    4 University of California San Diego La Jolla California United States 92037
    5 Santa Barbara Cottage Hospital Santa Barbara California United States 93102
    6 MedStar Washington Hospital Center Washington District of Columbia United States 20010
    7 University of Florida Jacksonville Jacksonville Florida United States 32209
    8 Velella Research Sarasota Florida United States 34239
    9 Tallahassee Research Institute, Inc. Tallahassee Florida United States 32308
    10 North Georgia Heart Foundation Gainesville Georgia United States 30501
    11 St. Luke's Idaho Cardiology Associates Boise Idaho United States 83712
    12 Jesse Brown VA Medical Center Chicago Illinois United States 60612
    13 St. Vincent Heart Center Indianapolis Indiana United States 46290
    14 Jewish and St. Mary's Hospital Louisville Kentucky United States 40202
    15 Lahey Clinic Burlington Massachusetts United States 01805
    16 McLaren Bay Region Bay City Michigan United States 48708
    17 MidMichigan Medical Center Midland Midland Michigan United States 48670
    18 William Beaumont Hospital Royal Oak Michigan United States 48073
    19 Missouri Cardiovascular Specialists, LLP Columbia Missouri United States 65201
    20 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    21 University of Buffalo Buffalo New York United States 14203
    22 Weill Cornell Medical College-New York Presbyterian New York New York United States 10021
    23 Columbia University Medical Center/New York Presbyterian Hospital New York New York United States 10032
    24 Novant Health Heart and Vascular Institute Charlotte North Carolina United States 28204
    25 LeBauer Cardiovascular Research Foundation Greensboro North Carolina United States 27401
    26 NC Heart and Vascular Research Raleigh North Carolina United States 27607
    27 Genesis Healthcare System Zanesville Ohio United States 43701
    28 Penn State - Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    29 Penn Presbyterian Medical Center Philadelphia Pennsylvania United States 19104
    30 Berks Cardiologists, Ltd. Reading Pennsylvania United States 19610
    31 Pinnacle Health Cardiovascular Institute Wormleysburg Pennsylvania United States 17043
    32 Rhode Island Hospital Providence Rhode Island United States 02903
    33 AnMed Health Anderson South Carolina United States 29621
    34 Black Hills Cardiovascular Research Rapid City South Dakota United States 57701
    35 Chattanooga Heart Institute Chattanooga Tennessee United States 37404
    36 Tennova Healthcare-Turkey Creek Medical Center Knoxville Tennessee United States 37934
    37 Houston Methodist Hospital Houston Texas United States 77030
    38 Providence Health Center Waco Texas United States 76712
    39 Carilion Clinic Roanoke Virginia United States 24014
    40 Mazankowski Alberta Heart Institute Edmonton Alberta Canada T6G 2B7
    41 Fraser Clinical Trials Inc. New Westminster British Columbia Canada V3L 3W4
    42 St. Paul's Hospital Vancouver British Columbia Canada V6E 1M7
    43 Victoria Heart Institute Foundation Victoria British Columbia Canada V8R 4R2
    44 Hamilton Health Sciences Hamilton Ontario Canada L8L 2X2
    45 The University of Ottawa Heart Institute Ottawa Ontario Canada K1Y 4W7
    46 Montreal Heart Institute Montréal Quebec Canada H1T 1C8
    47 Hôpital Maisonneuve-Rosemont Montréal Quebec Canada H1T 2M4
    48 Centre Hospitalier de l'université de Montréal Montréal Quebec Canada H2W 1T8
    49 Institut universitaire de cardiologie et de pneumologie de Québec Québec Quebec Canada G1V 4G5
    50 CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec Canada J1H 5N4
    51 Rigshospitalet Copenhagen University Hospital Copenhagen Denmark 2100
    52 Clinique Axium Aix-en-Provence France 13097
    53 Service de Cardiologie Interventionnelle - Pôle Santé République Clermont-Ferrand France 63050
    54 Clinique de Fontaine Fontaine-lès-Dijon France 21121
    55 Groupe Hospitalier Mutualiste de Grenoble Grenoble France 38000
    56 Hôpital Privé Jacques Cartier ICPS Massy France 91300
    57 Hôpital Privé Claude Galien Quincy-sous-Sénart France 91480
    58 Clinique Saint Hilaire Rouen France 76000
    59 CHU Toulouse Rangeuil Toulouse France
    60 Segeberger Kliniken GmbH Bad Segeberg Germany
    61 Herzzentrum Leipzig GmbH Leipzig Germany 04289
    62 Grande Ospedale Metropolitano Niguarda Milan Italy 20162
    63 Azienda Ospedaliera San Camillo Forlanini Rome Italy 00152
    64 Royal Bournemouth Hospital, Dorset Heart Centre Bournemouth United Kingdom
    65 Craigavon Cardiac Centre Craigavon United Kingdom BT63 5QQ
    66 Golden Jubilee National Hospital Glasgow United Kingdom G81 4DY

    Sponsors and Collaborators

    • Biosensors Europe SA

    Investigators

    • Study Chair: Martin Leon, Cardiovascular Research Foundation, New York
    • Principal Investigator: Mitchell Krucoff, Duke University
    • Principal Investigator: Philip Urban, Hôpital de la Tour

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biosensors Europe SA
    ClinicalTrials.gov Identifier:
    NCT02843633
    Other Study ID Numbers:
    • 16US01
    First Posted:
    Jul 26, 2016
    Last Update Posted:
    Feb 3, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Biosensors Europe SA
    Acute Coronary Syndrome
    Percutaneous Coronary Intervention
    Drug Coated Stent
    Drug Eluting Stent
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Hemorrhage
    Platelet Aggregation Inhibitors

    Study Results

    No Results Posted as of Feb 3, 2021