Leaders Free III: BioFreedom™ Clinical Trial

Sponsor

Biosensors Europe SA (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03118895

Collaborator

European Cardiovascular Research Center (Other)

404

Enrollment

Locations

Arm

61.7

Anticipated Duration (Months)

202

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding

Condition or Disease	Intervention/Treatment	Phase
Cardiac Death Myocardial Infarction Stent Thrombosis Bleeding Mortality	Device: BioFreedom™ BA9™ drug-coated stent	N/A

Detailed Description

Prospective, multi-center, open-label single-arm study designed to enroll 370 HBR patients (for at least 340 evaluable) at up to 20 centers in up to 2 European countries. 370 patients will receive a BioFreedomTM CoCr stent. All patients will be followed up for 2 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

404 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

370 high bleeding risk items

Primary Purpose:

Treatment

Official Title:

A Study Evaluating the Safety and Efficacy of the BioFreedom™ Biolimus A9™ Coated Cobalt Chromium Coronary Stent System in Patients at High Risk of Bleeding

Actual Study Start Date :

Nov 8, 2017

Actual Primary Completion Date :

Feb 5, 2020

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm Patients with coronary artery disease at high risk of bleeding receiving the BioFreedom™ BA9™ drug-coated stent	Device: BioFreedom™ BA9™ drug-coated stent Drug-coated stent for coronary arteries

Arm

Intervention/Treatment

Experimental: Treatment Arm

Patients with coronary artery disease at high risk of bleeding receiving the BioFreedom™ BA9™ drug-coated stent

Device: BioFreedom™ BA9™ drug-coated stent

Drug-coated stent for coronary arteries

Outcome Measures

Primary Outcome Measures

MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety) [at 1 year]
Incidence
clinically driven target lesion revascularization (efficacy) [at 1 year]
incidence

Secondary Outcome Measures

All-cause mortality [At 1 and 4 months, and 1 and 2 years]
incidence
Clinically Driven Target Lesion Revascularization [At 1 and 4 months, and 2 years]
Incidence
Clinically Driven Target Vessel Revascularization [At 1 and 4 months, and 2 years]
Incidence

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients at high bleeding risk (HBR) with an indication for percutaneous coronary intervention who can tolerate no more than one month of DAPT. This includes candidates with stable angina, silent ischemia, ACS (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:

Adjunctive oral anticoagulation treatment planned to continue after PCI
Age ≥ 75 years old
Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to inclusion into the trial)
Any prior intracerebral bleed
Any stroke in the last 12 months
Hospital admission for bleeding during the prior 12 months
Non skin cancer diagnosed or treated ≤ 3 years
Planned daily NSAID (other than aspirin) or steroids for ≥ 30 days after PCI
Planned surgery that would require interruption of DAPT (within next 12 months)
Renal failure defined as: Creatinine clearance <40 ml/min
Thrombocytopenia (PLT <100,000/mm3)
Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
Expected non-compliance to prolonged DAPT for other medical reasons

Exclusion Criteria:

Pregnant and breastfeeding women
Patients expected not to comply with 1 month DAPT
Patients requiring a planned staged PCI procedure more than one week after the index procedure
Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only).
Active bleeding at the time of inclusion
If patient requires a stent <2.5mm
If patient requires a stent >3.5mm
Cardiogenic shock
Compliance with long-term single anti-platelet therapy unlikely
Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any another P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9TM or a sensitivity to contrast media, which cannot be adequately pre-medicated
PCI during the previous 12 months for a lesion other than the target lesion
Participation in another clinical trial (12 months after index procedure)
Patients with a life expectancy of < 1 year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	at Hôpital Privé Claude Galien ICPS	Quincy sous Sénart	Essonne	France	91480
2	Triemli Stadtspital	Zürich		Switzerland

Sponsors and Collaborators

Biosensors Europe SA
European Cardiovascular Research Center

Investigators

Principal Investigator: Franz Eberli, Prof., Chief of Cardiology - Triemli Hospital Zurich - Switzerland
Principal Investigator: Philippe Garot, MD, Hôpital Privé Claude Galien ICPS - France