Prospective Registry of Patients With Acute Coronary Syndrome Treated With GENOSS Stent

Study Overview
=================
Brief Summary
-----------------
The investigators intend to establish a multi-center prospective observational study to evaluate the effectiveness and safety of Genoss DES by registering and tracking patients treated for acute coronary syndrome (ACS) as research subjects using Genoss DES, which was manufactured purely with domestic technology.

Detailed Description
-----------------
This study is a sponsor-initiated clinical trial (SIT) that will enroll patients treated for acute coronary syndrome using the GENOSS stent as research subjects, collect data on the patients' clinical and surgical procedures, and track the occurrence of clinical events. . This study is a prospective, multicenter registration observational study enrolling patients with acute coronary artery disease treated using the GENOSS stent at a total of 10 institutions. Since this study is a registered observation study, the number of subjects is not calculated separately, but a total of 1,000 subjects are scheduled to be recruited during the study registration period.

Official Title
-----------------
A Multi-center Prospective Registry of Patients With Acute Coronary Syndrome (ACS) Treated With GENOSSTM Sirolimus-eluting Stent

Conditions
-----------------
Acute Coronary Syndrome, Percutaneous Coronary Intervention

Intervention / Treatment
-----------------
* Device: Genoss DES


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over 19 years of age Patients who underwent Genoss DES for acute coronary syndrome (ACS) Patients who agreed in writing to participate in this registry study Exclusion Criteria: Patients for whom the subject or the subject's representative did not consent to participation in the study Patients who received a stent other than Genoss DES inserted into a lesion adjacent to the same blood vessel during the PCI procedure on the relevant procedure day.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Genoss DES|The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device-oriented composite end point | A composite index of cardiac death, any myocardial infarction not clearly attributable to a non-target vessel, and target-lesion revascularization. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with patient-oriented composite endpoint | Target lesion treatment failure up to 3 years after stent insertion Failure of target vessel treatment up to 3 years after stent insertion (cardiogenic death, myocardial infarction, target vessel revascularization (TVR)) All cause death up to 3 years after stent insertion Cardiac death up to 3 years after stent insertion All-cause mortality and myocardial infarction up to 3 years after stent insertion Cardiogenic death and myocardial infarction up to 3 years after stent insertion Target vessel revascularization up to 3 years after stent insertion Target lesion revascularization up to 3 years after stent insertion Occurrence of stent thrombosis up to 3 years after stent insertion | 3 years |