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)

Onyx ONE Clear: 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)

The purpose of this trial is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

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