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The objective of this study is to evaluate the efficacy and safety of the GENOSS SES in patients with acute coronary syndrome (ACS) in real-world pratice.
The Genoss SES 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 SES in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention.
The Genoss SES study is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss SES implantation in ACS patients undergoing percutaneous coronary intervention from 10 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 10 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GENOSSĀ® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4] | Patients with acute coronary syndrome treated with the GENOSS SES |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GENOSS Sirolimus Eluting Coronary Stent System | Device | The GENOSS SES is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt chromium stent platform and thin strut. |
| 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). | 12 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure (TLF) | Target lesion failure (TLF) is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR). | 3 years after the procedure |
| Target vessel failure (TVF) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation | Occurrence of stent-related events (cardiac death, myocardial infarction, stent thrombosis, bleeding, etc.) and any damage or complications that are believed to be related to the procedure. | 1 month, 12 months, 2 years, 3 years after the procedure |
<Inclusion Criteria>
<Exclusion Criteria>
Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents
- However, patients with hypersensitivity to contrast agents may be eligible if it can be controlled by steroids and pheniramine. Patients with known anaphylaxis are excluded
Patients who are pregnant or planning to become pregnant
Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration.
Patients with a life expectancy of less than 1 year
Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment.
Patients who have already received treatment with another DES (Drug Eluting Stent), BVS (Bioresorbable Vascular Scaffolds), or BMS (Bare Metal Stent) at the time of registration.
Patients currently participating in a randomized controlled trial involving medical devices.
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Patients with acute coronary syndrome treated with the GENOSS SES
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Target vessel failure (TVF) is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-vessel revascularization (TVR). |
| 3 years after the procedure |
| All-cause death | 3 years after the procedure |
| Cardiac death | 3 years after the procedure |
| All-cause death and any myocardial infarction | 3 years after the procedure |
| Cardiac death and target vessel-related myocardial infarction | 3 years after the procedure |
| Target vessel revascularization (TVR) | 3 years after the procedure |
| Target lesion revascularization (TLR) | 3 years after the procedure |
| Stent thrombosis | 3 years after the procedure |