Clinical trial NCT02843633: LEADERS FREE II: BioFreedom™ Pivotal Study
Official title: A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
High Bleeding Risk
Keywords: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Drug Coated Stent
Drug Eluting Stent
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
First posted: 2016-07-26
Enrollment: 1203
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: The composite of cardiac death and myocardial infarction at twelve months
timeFrame: 12 months
measure: The incidence of clinically driven target lesion revascularization at twelve months
timeFrame: 12 months
Secondary outcomes:
measure: The composite of cardiac death and myocardial infarction
timeFrame: 1, 2, and 6 months and 2 and 3 years
measure: The incidence of clinically driven target lesion revascularization
timeFrame: 1, 2, and 6 months and 2 and 3 years
measure: The composite of cardiac death, myocardial infarction and stent thrombosis
timeFrame: 1, 2, and 6 months and 1, 2, and 3 years
measure: Bleeding per Bleeding Academic Research Consortium (BARC) Criteria
timeFrame: 1, 2, and 6 months and 1, 2, and 3 years
measure: Cardiac Death
timeFrame: 1, 2, and 6 months and 1, 2, and 3 years
measure: Myocardial Infarction
timeFrame: 1, 2, and 6 months and 1, 2, and 3 years
measure: Stent Thrombosis per Academic Research Consortium (ARC) Definition
timeFrame: 1, 2, and 6 months and 1, 2, and 3 years
measure: Urgent target lesion revascularization
timeFrame: 1, 2, and 6 months and 1, 2, and 3 years
measure: Clinically driven target lesion revascularization at time points other than primary endpoint
timeFrame: followed for all target lesion revascularizations, up to 3 years
measure: Clinically driven target vessel revascularization
timeFrame: 1, 2, and 6 months and 1, 2, and 3 years
measure: All cause mortality
timeFrame: 1, 2, and 6 months and 1, 2, and 3 years
measure: Primary endpoints, in patients with at least 1 lesion treated with a trial stent of 3mm or less in nominal diameter
timeFrame: 1, 2, and 6 months and 1, 2, and 3 years
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Hot Springs
country: United States
facility: Tri-Lakes Research
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: University of Florida Jacksonville
state: Florida
city: Sarasota
country: United States
facility: Velella Research
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute, Inc.
state: Florida
city: Gainesville
country: United States
facility: North Georgia Heart Foundation
state: Georgia
city: Boise
country: United States
facility: St. Luke's Idaho Cardiology Associates
state: Idaho
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center
state: Indiana
city: Louisville
country: United States
facility: Jewish and St. Mary's Hospital
state: Kentucky
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Bay City
country: United States
facility: McLaren Bay Region
state: Michigan
city: Midland
country: United States
facility: MidMichigan Medical Center Midland
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Columbia
country: United States
facility: Missouri Cardiovascular Specialists, LLP
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College-New York Presbyterian
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian Hospital
state: New York
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Institute
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Zanesville
country: United States
facility: Genesis Healthcare System
state: Ohio
city: Hershey
country: United States
facility: Penn State - Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Reading
country: United States
facility: Berks Cardiologists, Ltd.
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Cardiovascular Research
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanooga Heart Institute
state: Tennessee
city: Knoxville
country: United States
facility: Tennova Healthcare-Turkey Creek Medical Center
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Waco
country: United States
facility: Providence Health Center
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Edmonton
country: Canada
facility: Mazankowski Alberta Heart Institute
state: Alberta
city: New Westminster
country: Canada
facility: Fraser Clinical Trials Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Heart Institute Foundation
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: The University of Ottawa Heart Institute
state: Ontario
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de l'université de Montréal
state: Quebec
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen University Hospital
city: Aix-en-Provence
country: France
facility: Clinique Axium
city: Clermont-Ferrand
country: France
facility: Service de Cardiologie Interventionnelle - Pôle Santé République
city: Fontaine-lès-Dijon
country: France
facility: Clinique de Fontaine
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier ICPS
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Toulouse
country: France
facility: CHU Toulouse Rangeuil
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Milan
country: Italy
facility: Grande Ospedale Metropolitano Niguarda
city: Rome
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital, Dorset Heart Centre
city: Craigavon
country: United Kingdom
facility: Craigavon Cardiac Centre
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
Study officials:
affiliation: Cardiovascular Research Foundation, New York
name: Martin Leon
role: STUDY_CHAIR
affiliation: Duke University
name: Mitchell Krucoff
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital de la Tour
name: Philip Urban
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.