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

Inclusion Criteria:

- Age ≥ 75 years old

- Any prior documented intracerebral bleed

- Any documented stroke in the last 12 months

- Hospital admission for bleeding during the prior 12 months

- Renal failure defined as: Creatinine clearance <40 ml/min

- Thrombocytopenia (PLT <100,000/mm3)

- Severe chronic liver disease defined as: subjects who have developed any of the
following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice

Exclusion Criteria:

- Pregnant and breastfeeding women

- Subjects requiring a planned PCI procedure after 1 month of index procedure

- Active bleeding at the time of inclusion

- Cardiogenic shock

- 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