LEADERS FREE II: BioFreedom™ Pivotal Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

1,203

Participants

Timeline

Start Date

February 14, 2017

Primary Completion Date

October 11, 2018

Study Completion Date

March 31, 2021

Conditions
Acute Coronary SyndromeHigh 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

Trial Locations (66)

2100

Rigshospitalet Copenhagen University Hospital, Copenhagen

10021

Weill Cornell Medical College-New York Presbyterian, New York

10032

Columbia University Medical Center/New York Presbyterian Hospital, New York

13097

Clinique Axium, Aix-en-Provence

14203

University of Buffalo, Buffalo

17033

Penn State - Milton S. Hershey Medical Center, Hershey

17043

Pinnacle Health Cardiovascular Institute, Wormleysburg

19104

Penn Presbyterian Medical Center, Philadelphia

19610

Berks Cardiologists, Ltd., Reading

20010

MedStar Washington Hospital Center, Washington D.C.

20162

Grande Ospedale Metropolitano Niguarda, Milan

21121

Clinique de Fontaine, Fontaine-lès-Dijon

24014

Carilion Clinic, Roanoke

27401

LeBauer Cardiovascular Research Foundation, Greensboro

27607

NC Heart and Vascular Research, Raleigh

28204

Novant Health Heart and Vascular Institute, Charlotte

29621

AnMed Health, Anderson

30501

North Georgia Heart Foundation, Gainesville

32209

University of Florida Jacksonville, Jacksonville

32308

Tallahassee Research Institute, Inc., Tallahassee

34239

Velella Research, Sarasota

35801

Heart Center Research, LLC, Huntsville

37404

Chattanooga Heart Institute, Chattanooga

37934

Tennova Healthcare-Turkey Creek Medical Center, Knoxville

38000

Groupe Hospitalier Mutualiste de Grenoble, Grenoble

40202

Jewish and St. Mary's Hospital, Louisville

43701

Genesis Healthcare System, Zanesville

46290

St. Vincent Heart Center, Indianapolis

48073

William Beaumont Hospital, Royal Oak

48670

MidMichigan Medical Center Midland, Midland

48708

McLaren Bay Region, Bay City

57701

Black Hills Cardiovascular Research, Rapid City

60612

Jesse Brown VA Medical Center, Chicago

63050

Service de Cardiologie Interventionnelle - Pôle Santé République, Clermont-Ferrand

64111

Saint Luke's Hospital of Kansas City, Kansas City

65201

Missouri Cardiovascular Specialists, LLP, Columbia

71901

Tri-Lakes Research, Hot Springs

76000

Clinique Saint Hilaire, Rouen

76712

Providence Health Center, Waco

77030

Houston Methodist Hospital, Houston

83712

St. Luke's Idaho Cardiology Associates, Boise

91300

Hôpital Privé Jacques Cartier ICPS, Massy

91480

Hôpital Privé Claude Galien, Quincy-sous-Sénart

92037

Scripps Health, La Jolla

University of California San Diego, La Jolla

93102

Santa Barbara Cottage Hospital, Santa Barbara

01805

Lahey Clinic, Burlington

02903

Rhode Island Hospital, Providence

T6G 2B7

Mazankowski Alberta Heart Institute, Edmonton

V3L 3W4

Fraser Clinical Trials Inc., New Westminster

V6E 1M7

St. Paul's Hospital, Vancouver

V8R 4R2

Victoria Heart Institute Foundation, Victoria

L8L 2X2

Hamilton Health Sciences, Hamilton

K1Y 4W7

The University of Ottawa Heart Institute, Ottawa

H1T 1C8

Montreal Heart Institute, Montreal

H1T 2M4

Hôpital Maisonneuve-Rosemont, Montreal

H2W 1T8

Centre Hospitalier de l'université de Montréal, Montreal

G1V 4G5

Institut universitaire de cardiologie et de pneumologie de Québec, Québec

J1H 5N4

CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke

Unknown

CHU Toulouse Rangeuil, Toulouse

Segeberger Kliniken GmbH, Bad Segeberg

Royal Bournemouth Hospital, Dorset Heart Centre, Bournemouth

04289

Herzzentrum Leipzig GmbH, Leipzig

00152

Azienda Ospedaliera San Camillo Forlanini, Rome

BT63 5QQ

Craigavon Cardiac Centre, Craigavon

G81 4DY

Golden Jubilee National Hospital, Glasgow

All Listed Sponsors
lead

Biosensors Europe SA

INDUSTRY

NCT02843633 - LEADERS FREE II: BioFreedom™ Pivotal Study | Biotech Hunter | Biotech Hunter