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The objective of this study is to evaluate the efficacy and safety of the GENOSS DES in patients with coronary artery disease in real-world pratice.
The Genoss DES is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of the Genoss DES in all-comer patients undergoing percutaneous coronary intervention.
The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss DES implantation in all-comer patients undergoing percutaneous coronary intervention from 12 sites in South Korea. The primary endpoint was a device-oriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GENOSS Sirolimus Eluting Coronary Stent System | Patients with coronary artery disease treated with the GENOSS DES |
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| Measure | Description | Time Frame |
|---|---|---|
| Device-oriented composite endpoint | DOCE is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR). | at 12 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-oriented composite endpoint | POCE is defined as a composite of all-cause death, any myocardial infarction, and any revascularization. | at 12 months after the procedure |
| All-cause deaths |
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<Inclusion Criteria>
<Exclusion Criteria>
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Patients with coronary artery disease treated with GENOSS DES
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | 08308 | 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 |
| Cardiac death | at 12 months after the procedure |
| Non-cardiac death | at 12 months after the procedure |
| Any myocardial infarction | at 12 months after the procedure |
| target vessel-related myocardial infarction (TV-MI) | at 12 months after the procedure |
| Any revascularization | at 12 months after the procedure |
| Clinically indicated target lesion revascularization (TLR) | at 12 months after the procedure |
| Stent thrombosis | at 12 months after the procedure |
| Lesion success | When the final residual lesion stenosis is less than 50% using any surgical method. | during the procedure |
| Procedure success | When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedure death, myocardial infarction, or revascularization during the hospitalization period. | immediately after the procedure |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |