LEADERS FREE II: BioFreedom™ Pivotal Study

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02843633
• Other study ID #: 16US01
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: March 2021

Study information

• Verified date: February 2021
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1203
• Est. completion date: March 2021
• Est. primary completion date: October 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Hemorrhage
• High Bleeding Risk

Intervention

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

Locations

Country	Name	City	State
Canada	Mazankowski Alberta Heart Institute	Edmonton	Alberta
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Centre Hospitalier de l'université de Montréal	Montréal	Quebec
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	Fraser Clinical Trials Inc.	New Westminster	British Columbia
Canada	The University of Ottawa Heart Institute	Ottawa	Ontario
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	St. Paul's Hospital	Vancouver	British Columbia
Canada	Victoria Heart Institute Foundation	Victoria	British Columbia
Denmark	Rigshospitalet Copenhagen University Hospital	Copenhagen
France	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
Germany	Segeberger Kliniken GmbH	Bad Segeberg
Germany	Herzzentrum Leipzig GmbH	Leipzig
Italy	Grande Ospedale Metropolitano Niguarda	Milan
Italy	Azienda Ospedaliera San Camillo Forlanini	Rome
United Kingdom	Royal Bournemouth Hospital, Dorset Heart Centre	Bournemouth
United Kingdom	Craigavon Cardiac Centre	Craigavon
United Kingdom	Golden Jubilee National Hospital	Glasgow
United States	AnMed Health	Anderson	South Carolina
United States	McLaren Bay Region	Bay City	Michigan
United States	St. Luke's Idaho Cardiology Associates	Boise	Idaho
United States	University of Buffalo	Buffalo	New York
United States	Lahey Clinic	Burlington	Massachusetts
United States	Novant Health Heart and Vascular Institute	Charlotte	North Carolina
United States	Chattanooga Heart Institute	Chattanooga	Tennessee
United States	Jesse Brown VA Medical Center	Chicago	Illinois
United States	Missouri Cardiovascular Specialists, LLP	Columbia	Missouri
United States	North Georgia Heart Foundation	Gainesville	Georgia
United States	LeBauer Cardiovascular Research Foundation	Greensboro	North Carolina
United States	Penn State - Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Tri-Lakes Research	Hot Springs	Arkansas
United States	Houston Methodist Hospital	Houston	Texas
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	St. Vincent Heart Center	Indianapolis	Indiana
United States	University of Florida Jacksonville	Jacksonville	Florida
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Tennova Healthcare-Turkey Creek Medical Center	Knoxville	Tennessee
United States	Scripps Health	La Jolla	California
United States	University of California San Diego	La Jolla	California
United States	Jewish and St. Mary's Hospital	Louisville	Kentucky
United States	MidMichigan Medical Center Midland	Midland	Michigan
United States	Columbia University Medical Center/New York Presbyterian Hospital	New York	New York
United States	Weill Cornell Medical College-New York Presbyterian	New York	New York
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	Black Hills Cardiovascular Research	Rapid City	South Dakota
United States	Berks Cardiologists, Ltd.	Reading	Pennsylvania
United States	Carilion Clinic	Roanoke	Virginia
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Velella Research	Sarasota	Florida
United States	Tallahassee Research Institute, Inc.	Tallahassee	Florida
United States	Providence Health Center	Waco	Texas
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania
United States	Genesis Healthcare System	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Biosensors Europe SA

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite of cardiac death and myocardial infarction at twelve months		12 months
Primary	The incidence of clinically driven target lesion revascularization at twelve months		12 months
Secondary	The composite of cardiac death and myocardial infarction		1, 2, and 6 months and 2 and 3 years
Secondary	The incidence of clinically driven target lesion revascularization		1, 2, and 6 months and 2 and 3 years
Secondary	The composite of cardiac death, myocardial infarction and stent thrombosis		1, 2, and 6 months and 1, 2, and 3 years
Secondary	Bleeding per Bleeding Academic Research Consortium (BARC) Criteria		1, 2, and 6 months and 1, 2, and 3 years
Secondary	Cardiac Death		1, 2, and 6 months and 1, 2, and 3 years
Secondary	Myocardial Infarction		1, 2, and 6 months and 1, 2, and 3 years
Secondary	Stent Thrombosis per Academic Research Consortium (ARC) Definition		1, 2, and 6 months and 1, 2, and 3 years
Secondary	Urgent target lesion revascularization		1, 2, and 6 months and 1, 2, and 3 years
Secondary	Clinically driven target lesion revascularization at time points other than primary endpoint		followed for all target lesion revascularizations, up to 3 years
Secondary	Clinically driven target vessel revascularization		1, 2, and 6 months and 1, 2, and 3 years
Secondary	All cause mortality		1, 2, and 6 months and 1, 2, and 3 years
Secondary	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