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)

Inclusion Criteria:

To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject had to meet
at least one of the criteria detailed below:

   - Adjunctive chronic oral anticoagulation treatment planned to continue after PCI

   - Age ≥ 75 years old

   - Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to
   procedure)

   - Any prior documented intracerebral bleed

   - Any documented stroke in the last 12 months

   - Hospital admission for bleeding during the prior 12 months

   - Active non-skin cancer currently undergoing treatment or surveillance (in lieu of
   treatment)

   - Planned daily NSAID (other than aspirin) or steroids for ≥30 days after PCI

   - Planned surgery that would require interruption of DAPT (within the next 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

   - Expected non-compliance for at least 6 months DAPT for other medical reasons

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