GENOSSACS: Prospective Registry of Patients With Acute Coronary Syndrome Treated With GENOSS Stent
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- device-oriented composite end point [12 months]
A composite index of cardiac death, any myocardial infarction not clearly attributable to a non-target vessel, and target-lesion revascularization.
Secondary Outcome Measures
- Number of participants with patient-oriented composite endpoint [3 years]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults over 19 years of age
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Patients who underwent Genoss DES for acute coronary syndrome (ACS)
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Patients who agreed in writing to participate in this registry study
Exclusion Criteria:
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Patients for whom the subject or the subject's representative did not consent to participation in the study
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Bundang Hospital | Seongnam | Gyeonggi-do | Korea, Republic of | 13620 |
Sponsors and Collaborators
- Genoss Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B-1909-564-302