A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)

Exclusion Criteria

• •Pregnant and breastfeeding women
• •Subjects requiring a planned PCI procedure after 1 month of index procedure
• •Procedure planned to require non-trial stents, stand-alone POBA, or stand-alone atherectomy
• •Active bleeding at the time of inclusion
• •Cardiogenic shock
• •Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure
• •Subject not expected to comply with long-term single antiplatelet therapy
• •A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (eg, BioLinx™), stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
• •PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
• •Participation in another clinical study within 12 months after index procedure
• •Subjects with life expectancy of less than 2 years