Coronary Arterial Disease (CAD)
Conditions
Brief summary
Efficacy and Safety of GENOSS SES in patients with coronary artery disease
Detailed description
GENOSS SES
Interventions
None listed
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
1. Patients of 19 and over 2. Patients with coronary artery disease 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 2. Patients who are pregnant or planning to become pregnant 3. Patients with a planned surgery to discontinue antiplatelet agents within 12 months 4. Patients with a life expectancy of less than 1 year 5. Patient with cardiogenic shock at the time of hospitalization and had a low chance of survival based on medical judgment. 6. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration 7. Patients participating in randomized controlled trials using other medical devices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device-oriented composite endpoint | at 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 |
|---|---|---|
| Cardiac death | at 12 months after the procedure | — |
| Patient-oriented composite endpoint | at 12 months after the procedure | POCE is defined as a composite of all-cause death, any myocardial infarction, and any revascularization. |
| Non-cardiac death | at 12 months after the procedure | — |
| Any myocardial infarction | at 12 months after the procedure | — |
| Target vessel-related myocardial infarction (TV-MI) | at 12 months after the procedure | — |
| All-cause deaths | at 12 months after the procedure | — |
| Clinically indicated target lesion revascularization (TLR) | at 12 months after the procedure | — |
| Stent thrombosis | at 12 months after the procedure | — |
| Lesion success | during the procedure | When the final residual lesion stenosis is less than 50% using any surgical method. |
| Procedure success | immediately after the procedure | When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedure death, myocardial infarction, or revascularization during the hospitalization period. |
| Any revascularization | at 12 months after the procedure | — |
Countries
South Korea
Outcome results
None listed