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

Starting soon · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT07566091

Run by

Jung-min Ahn

People needed

2034

Starts

2026-06-15

Expected to finish

2028-06-15

Last updated by the study team

2026-05-04

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

• Asan Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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