Lead Sponsor

Biosensors Europe SA

Collaborators

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month 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.

•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).

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