Coronary Artery Disease
Conditions
Keywords
acute coronary syndrome, chronic coronary syndrome, D+Storm Novonix, sirolimus-ascorbic acid eluting stent, everolimus-eluting stent, percutaneous coronary intervention
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.
Interventions
DEVICESirolimus-Ascorbic Acid Eluting Stent
bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent
DEVICEEverolimus-Eluting Stent
bioabsorbable polymer everolimus-eluting stent
Sponsors
Jung-min Ahn
The CardioVascular Research Foundation (CVRF)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The event rate of Target Lesion Failure | 1 year | Target Lesion Failure is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The event rate of Device success | 1 year | Acute Success Endpoints\_lesion level |
| The event rate of Procedural success | 1 year | Acute Success Endpoints\_patient level |
| The event rate of Death from any causes | 1 year | Major Composite Clinical Endpoints\_Patient-Oriented Clinical Endpoint, POCE |
| The event rate of Any stroke | 1 year | Major Composite Clinical Endpoints\_Patient-Oriented Clinical Endpoint, POCE |
| The event rate of Any myocardial infarction | 1 year | Major Composite Clinical Endpoints\_Patient-Oriented Clinical Endpoint, POCE |
| The event rate of Any repeat revascularization | 1 year | Major Composite Clinical Endpoints\_Patient-Oriented Clinical Endpoint, POCE |
| The event rate of Cardiovascular death | 1 year | Major Composite Clinical Endpoints\_Target Vessel Failure |
| The event rate of Target vessel myocardial infarction | 1 year | Major Composite Clinical Endpoints\_Target Vessel Failure |
| The event rate of Target vessel revascularization | 1 year | Major Composite Clinical Endpoints\_Target Vessel Failure |
| The event rate of All-cause death | 1 year | Individual Clinical Endpoints\_Mortality |
| The event rate of Cardiac death | 1 year | Individual Clinical Endpoints\_Mortality |
| The event rate of Non-cardiac death | 1 year | Individual Clinical Endpoints\_Mortality |
| The event rate of All myocardial infarction including Q wave and Non-Q wave | 1 year | Individual Clinical Endpoints\_Myocardial Infarction |
| The event rate of Non-target vessel myocardial infarction | 1 year | Individual Clinical Endpoints\_Myocardial Infarction |
| The event rate of All revascularization | 1 year | Individual Clinical Endpoints\_Revascularization |
| The event rate of All target lesion revascularization | 1 year | Individual Clinical Endpoints\_Revascularization |
| The event rate of All target vessel revascularization | 1 year | Individual Clinical Endpoints\_Revascularization |
| The event rate of Non-target vessel revascularization | 1 year | Individual Clinical Endpoints\_Revascularization |
| The event rate of Ischemic stroke | 1 year | Individual Clinical Endpoints\_Stroke |
| The event rate of Hemorrhagic stroke | 1 year | Individual Clinical Endpoints\_Stroke |
Countries
South Korea
Contacts
CONTACTJung-hee Ham Project Manager, Registered Nurse
Outcome results
None listed