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

ConditionCoronary Artery Disease

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19+

SponsorJung-min Ahn

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Sirolimus-Ascorbic Acid Eluting Stent
Everolimus-Eluting Stent

Treatment groups

2,034 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Jung-min Ahn

Lead sponsor

Asan Medical Center

Sponsor institution

The CardioVascular Research Foundation (CVRF)

Collaborator

Source ClinicalTrials.gov