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:

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)