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The objective of study is to evaluate the efficacy and safety of short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.
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 short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.
The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of short duration of DAPT (3 months for SCAD, 6 months for ACS) after Genoss DES implantation in patients with coronary artery disease from 6 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. The key secondary endpoint was a patient-oriented composite endpoint (POCE), defined as a composite of all-cause death, any myocardial infarction, and any revascularization 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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YoungJin Youn | Contact | 033-741-0910 | younyj@yonsei.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju Severance Christian Hospital | Recruiting | Wŏnju | Gangwon State | South Korea |
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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-realted 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 by ARC definition | at 12 months after the procedure |
| Lesion success | When the final residual lesion stenosis is less than 30% using any surgical method. | during the procedure |
| Procedure success | When the final residual lesion stenosis is less than 30% using any surgical method, and there is no post-procedure death, myocardial infarction, or revascularization during the hospitalization period | immediately after the procedure |