Acute Coronary Syndrome, Percutaneous Coronary Intervention
Conditions
Keywords
ACS
Brief summary
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.
Detailed description
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.
Interventions
DEVICEGENOSS Sirolimus Eluting Coronary Stent System
The GENOSS SES is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt chromium stent platform and thin strut.
Sponsors
Genoss Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\<Inclusion Criteria\> 1. Patients of 19 and over 2. Patients with acute coronary syndrome treated with GENOSS SES 3. Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants. \<
Exclusion criteria
\> 1. 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 2. Patients who are pregnant or planning to become pregnant 3. Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration. 4. Patients with a life expectancy of less than 1 year 5. Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment. 6. 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. 7. Patients currently participating in a randomized controlled trial involving medical devices.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device-oriented composite endpoint | 12 months after the procedure | DOCE is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure (TLF) | 3 years after the procedure | 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). |
| Target vessel failure (TVF) | 3 years after the procedure | 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). |
| 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 | — |
Countries
South Korea
Outcome results
None listed