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In this study, the investigators evaluated the effectiveness and safety of using the GENOSSĀ® DES, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.
This study is a sponsor-initiated clinical trial (SIT) that enrolls patients who underwent percutaneous coronary intervention using the GENOSSĀ® DES drug-eluting stent.
As it is a prospective, multicenter, observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants at 7 institutions 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 coronary artery disease who require interventional treatment through stent insertion in real-world practice (all-comer) |
|
| 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 |
|---|---|---|
| All deaths | at 12 months after the procedure | |
| Cardiac death | at 12 months after the procedure | |
| TV-MI (target vessel-myocardial infarction) |
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<Inclusion Criteria>
<Exclusion Criteria>
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Coronary artery disease patients who underwent coronary intervention using the GENOSSĀ® DES
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | Seoul | 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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| at 12 months after the procedure |
| any MI (myocardial infarction) | at 12 months after the procedure |
| ID-TVR (ischemia-driven target vessel revascularization) | at 12 months after the procedure |
| ID-TLR (ischemia-driven target lesion revascularization) | at 12 months after the procedure |
| Stent thrombosis by ARC definition | at 12 months after the procedure |
| Procedure success | When the final internal stenosis rate is less than 30% as assessed visually on angiography after the procedure and there is no death, Q-wave myocardial infarction, or urgent revascularization during hospitalization. | during the hospitalization period (up to 3 days) |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |