LEADERS FREE II: BioFreedom™ Pivotal Study

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

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:

• 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 the index procedure)
• 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, with a perceived increased risk for bleeding
• Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or steroids for >30 days after PCI
• Planned surgery that would require interruption of DAPT (within next 6 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 planned to require non-study stents, or stand-alone plain old balloon angioplasty (POBA) or stand-alone atherectomy
• Active bleeding at the time of inclusion
• Reference vessel diameter <2.25 - >4.0mm
• Cardiogenic shock
• Compliance with long-term single anti-platelet therapy unlikely
• 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
• PCI during the previous 12 months for a lesion other than the target lesion of the index procedure
• Participation in another clinical trial (12 months after index procedure)
• Patients with a life expectancy of < 12 months
• Patients under judicial protection, tutorship or curatorship (for France only)