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| Name | Class |
|---|---|
| The CardioVascular Research Foundation (CVRF) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sirolimus-Ascorbic Acid Eluting Stent | Experimental | D+STORM NOVONIX stent |
|
| Everolimus-Eluting Stent | Active Comparator | SYNERGY XD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus-Ascorbic Acid Eluting Stent | Device | bioabsorbable polymer Sirolimus-Ascorbic Acid Eluting Stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| The event rate of Target Lesion Failure | Target Lesion Failure is defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically driven target-lesion revascularization. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The event rate of Device success | Acute Success Endpoints_lesion level | 1 year |
| The event rate of Procedural success | Acute Success Endpoints_patient level |
| Measure | Description | Time Frame |
|---|---|---|
| The event rate of Definite or probable stent thrombosis | Safety Endpoints | 1 year |
| The event rate of Definite stent thrombosis | Safety Endpoints |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-hee Ham Project Manager, Registered Nurse | Contact | 82-2-3010-4728 | cvcrc5@amc.seoul.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Everolimus-Eluting Stent | Device | bioabsorbable polymer everolimus-eluting stent |
|
| 1 year |
| The event rate of Death from any causes | Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE | 1 year |
| The event rate of Any stroke | Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE | 1 year |
| The event rate of Any myocardial infarction | Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE | 1 year |
| The event rate of Any repeat revascularization | Major Composite Clinical Endpoints_Patient-Oriented Clinical Endpoint, POCE | 1 year |
| The event rate of Cardiovascular death | Major Composite Clinical Endpoints_Target Vessel Failure | 1 year |
| The event rate of Target vessel myocardial infarction | Major Composite Clinical Endpoints_Target Vessel Failure | 1 year |
| The event rate of Target vessel revascularization | Major Composite Clinical Endpoints_Target Vessel Failure | 1 year |
| The event rate of All-cause death | Individual Clinical Endpoints_Mortality | 1 year |
| The event rate of Cardiac death | Individual Clinical Endpoints_Mortality | 1 year |
| The event rate of Non-cardiac death | Individual Clinical Endpoints_Mortality | 1 year |
| The event rate of All myocardial infarction including Q wave and Non-Q wave | Individual Clinical Endpoints_Myocardial Infarction | 1 year |
| The event rate of Non-target vessel myocardial infarction | Individual Clinical Endpoints_Myocardial Infarction | 1 year |
| The event rate of All revascularization | Individual Clinical Endpoints_Revascularization | 1 year |
| The event rate of All target lesion revascularization | Individual Clinical Endpoints_Revascularization | 1 year |
| The event rate of All target vessel revascularization | Individual Clinical Endpoints_Revascularization | 1 year |
| The event rate of Non-target vessel revascularization | Individual Clinical Endpoints_Revascularization | 1 year |
| The event rate of Any stroke | Individual Clinical Endpoints_Stroke | 1 year |
| The event rate of Ischemic stroke | Individual Clinical Endpoints_Stroke | 1 year |
| The event rate of Hemorrhagic stroke | Individual Clinical Endpoints_Stroke | 1 year |
| 1 year |
| The event rate of Probable stent thrombosis | Safety Endpoints | 1 year |
| The event rate of The Bleeding Academic Research Consortium (BARC) type 2, 3, 4, 5 | Safety Endpoints | 1 year |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |