NCT07566091Recruiting
Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2034 (estimated)
- First submitted
- 27 Apr 2026
- Start date
- 6 Oct 2026
- Primary completion date
- 15 Jun 2027
- Lead sponsor
- Jung-min Ahn
- Diseases
- Coronary artery disease
- NCT number
- NCT07566091
What you commit to
- Study type: Interventional
- Planned participants: 2034
- From 6 Oct 2026 to the primary completion date, 15 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cardiogenic shock within 48 hours prior to the procedure
- 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
Other illness
- Known hypersensitivity to sirolimus, everolimus, ascorbic acid, or stent components (e.g., cobalt-chromium alloy)
- Life expectancy of less than 1 year or presence of serious non-cardiac conditions that may affect compliance with the study protocol
Lab values
- 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
Other
- Patients who are unwilling or unable to comply with the study protocol
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.