Overview
The objective of this study is to demonstrate the primary hypothesis that, in patients with chronic and acute coronary syndromes requiring percutaneous coronary intervention (PCI), the novel sirolimus-ascorbic acid eluting stent (D+Storm Novonix) is non-inferior to the standard treatment, the everolimus-eluting stent (Synergy XD), with respect to the incidence of target lesion failure (TLF) at 1 year after treatment, where TLF is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization.
Eligibility
Inclusion Criteria:
- Adult men and women aged 19 years or older
- Patients with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who require percutaneous coronary intervention (PCI) (all-comers)
- Patients who have voluntarily provided written informed consent to participate in the study
Exclusion Criteria:
- Cardiogenic shock within 48 hours prior to the procedure
- Known hypersensitivity to sirolimus, everolimus, ascorbic acid, or stent components (e.g., cobalt-chromium alloy)
- Patients unable to maintain dual antiplatelet therapy (DAPT), including aspirin and a P2Y12 inhibitor, for 1 year
- Women who are pregnant, breastfeeding, or of childbearing potential who meet any of the following:
- Have not confirmed a negative pregnancy test prior to enrollment
- Do not agree to use, or are unlikely to maintain, an acceptable method of contraception during the study period
- Clinically significant abnormalities identified during study visits, physical examination, laboratory tests, or electrocardiogram (ECG) that, in the investigator's judgment, may interfere with the safe completion of the study
- Life expectancy of less than 1 year or presence of serious non-cardiac conditions that may affect compliance with the study protocol
- Patients who are unwilling or unable to comply with the study protocol
