NCT07566091 Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers
| NCT ID | NCT07566091 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jung-min Ahn |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,034 participants |
| Start Date | 2026-10-06 |
| Primary Completion | 2027-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,034 participants in total. It began in 2026-10-06 with a primary completion date of 2027-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07566091 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07566091 currently recruiting?
Yes, NCT07566091 is actively recruiting participants. Contact the research team at cvcrc5@amc.seoul.kr for enrollment information.
Where is the NCT07566091 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07566091 clinical trial?
NCT07566091 is sponsored by Jung-min Ahn. The trial plans to enroll 2,034 participants.