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NCT07566091
Noninferiority Trial Of Sirolimus With Ascorbic Acid Versus Everolimus in All-comers
Conditions: Coronary Artery Disease
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 2034
Sponsor: Jung-min Ahn
Location: Asan Medical Center Seoul
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
Source: ClinicalTrials.gov (NCT07566091). StuddyBuddy aggregates publicly available trial information.