A Randomized Clinical Evaluation of the BioFreedom™ Stent

Exclusion Criteria

• •1. Pregnancy
• •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 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, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated.
• •10. Participation in another clinical trial (12 months after index procedure).