Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers (NCT07566091) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers
South Korea2,034 participantsStarted 2026-06-15
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
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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
✕. 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