Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers

Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers

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.

Inclusion Criteria:

1. Adult men and women aged 19 years or older
2. Patients with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who require percutaneous coronary intervention (PCI) (all-comers)
3. Patients who have voluntarily provided written informed consent to participate in the study

Exclusion Criteria:

1. Cardiogenic shock within 48 hours prior to the procedure
2. Known hypersensitivity to sirolimus, everolimus, ascorbic acid, or stent components (e.g., cobalt-chromium alloy)
3. Patients unable to maintain dual antiplatelet therapy (DAPT), including aspirin and a P2Y12 inhibitor, for 1 year
4. Women who are pregnant, breastfeeding, or of childbearing potential
5. 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
6. Life expectancy of less than 1 year or presence of serious non-cardiac conditions that may affect compliance with the study protocol
7. Patients who are unwilling or unable to comply with the study protocol