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| Name | Class |
|---|---|
| Severance Hospital | OTHER |
| Genoss Co., Ltd. | INDUSTRY |
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This is a prospective cohort study to evaluate the long-term effect and safety of Genoss drug-eluting stents (DES) in patients with coronary artery disease with high ischemic features.
It is known that ischemic events after percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) increase as the anatomical, physiological, or functional complexity of coronary artery disease increases. Recently, the concept of complex higher-risk and clinically indented procedure (CHIP) has been proposed, which includes patients with various medical conditions, patients with various heart conditions, and patients with technically complex PCI. Until now, Genoss stents have no data on the evaluation of stents in patients with coronary artery disease and high ischemic features.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Ischemic Group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genoss DES | Device | The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with device-oriented compopsite endpoint (TLF) | A composite rate of cardiac death (CD), target-vessel myocardial infarction (TV-MI), Ischemic driven target lesion revascularization (ID-TLR) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with patient-oriented composite endpoint | A composite rate of all death, all myocardial infarction, and all revascularization | 12 months |
| Number of participants with all death |
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Inclusion Criteria:
Exclusion Criteria:
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All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)
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| Name | Affiliation | Role |
|---|---|---|
| Deok-Kyu Cho, MD, PhD | Yongin Severance Hopistal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongin Severance Hospital | Yongin | Gyeonggi-do | 16995 | South Korea |
The data set is available from the the corresponding author upon reasonable request.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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A composite rate of all death
| 12 months |
| Number of participants with cardiac death | A composite rate of cardiac death | 12 months |
| Number of participants with non-cardiac death | A composite rate of non-cardiac death | 12 months |
| Number of participants with all myocardial infarction | A composite rate of all myocardial infarction | 12 months |
| Number of participants with target-vessel myocardial infarction (TV-MI) | A composite rate of target-vessel myocardial infarction (TV-MI) | 12 months |
| Number of participants with all revascularization | A composite rate of all revascularization | 12 months |
| Number of participants with ischemic driven target lesion revascularization (ID-TLR) | A composite rate of ischemic driven target lesion revascularization (ID-TLR) | 12 months |
| Number of participants with stent thrombosis | A composite rate of stent thrombosis | Within 24 hours, 30 days, 12 months |
| Number of participants with non-ischemic targeted lesion perfusion | A composite rate of non-ischemic targeted lesion perfusion | 12 months |
| Number of participants with Non target vessel myocardial infarction | A composite rate of Non target vessel myocardial infarction | 12 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |