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The investigators intend to establish a multicenter prospective observational study by enrolling and tracking patients with multivessel coronary artery disease (MVCAD) using Genoss DES, a device manufactured with pure domestic technology. The study aims to evaluate the efficacy and safety of Genoss DES in MVCAD patients.
This study is a sponsor-driven clinical trial (SIT) that aims to enroll patients who have undergone treatment for multivessel coronary artery disease using Genoss stents. The study involves collecting data on the clinical and surgical processes of patients and tracking the occurrence of clinical events.
This prospective, multicenter observational study registers patients with acute coronary artery disease who have been treated with GENOSS stents at a total of 8 institutions.
As it is an observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants during the study registration period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GENOSSĀ® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4] | Patients with multivessel coronary artery disease (MVCAD) who underwent percutaneous coronary intervention using GENOSSĀ® DES |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GENOSS® DES Sirolimus Eluting Coronary Stent System | Device | The GENOSS® DES is L-605 cobalt chromium (CoCr) platform with a strut thickness of 70µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers. |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization) | at 12 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events (MACE) | The composite end point of death, myocardial infarction, target lesion revascularization | at 12 months after the procedure |
| Cardiac death | at 12 months after the procedure |
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<Inclusion Criteria>
(However, in the case of foreigners, only those who can speak Korean fluently and understand Korean documents such as the consent form are included.)
<Exclusion Criteria>
Subject
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Patients with multivessel coronary artery disease (MVCAD) who underwent percutaneous coronary intervention using GENOSSĀ® DES
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University GURO Hospital | Seoul | Seoul | 08308 | South Korea |
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| Non-cardiac death | at 12 months after the procedure |
| TV-MI (target vessel-myocardial infarction) | at 12 months after the procedure |
| Non-target vessel myocardial infarction | at 12 months after the procedure |
| ID-TVR (ischemia-driven target vessel revascularization) | at 12 months after the procedure |
| Non-ischemia driven target vessel revascularization | at 12 months after the procedure |
| Incidence rate of acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year | Acute (within 24 hours), subacute (within 30 days), late (within 1 year) | within 24 hours, 30 days, 1 year |
| Device success | The clinical device is successfully delivered to the target lesion, inflated normally, and recovered intact. | during the procedure |
| Procedure success | When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedural death, myocardial infarction, or revascularization during the hospitalization period. | during the hospitalization period (up to 3 days) |