Coronary Artery Disease, Dual Antiplatelet Therapy, Percutaneous Coronary Intervention
Conditions
Brief summary
The objective of study is to evaluate the efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.
Detailed description
The Genoss DES 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 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure. The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of 1 year duration of DAPT after Genoss DES implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure from 9 sites in South Korea. The primary endpoint was a deviceoriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 12 months. The key secondary endpoint was a patient-oriented composite endpoint (POCE), defined as a composite of all-cause death, any myocardial infarction, and any revascularization at 12 months.
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 with cardiogenic shock at the time of hospitalization 2. Patients who are pregnant or planning to become pregnant 3. Patients with a life expectancy of less than 1 year 4. Patients participating in randomized controlled trials using other medical devices 5. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration (However, other stent insertions are allowed due to failure of GENOSS DES insertion)
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 |
|---|---|---|
| All-cause deaths | at 12 months after the procedure | — |
| Cardiac death | at 12 months after the procedure | — |
| Non-cardiac death | at 12 months after the procedure | — |
| Any myocardial infarction | at 12 months after the procedure | — |
| Target vessel-realted myocardial infarction (TV-MI) | 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. |
| Revascularization of clinically appropriate target lesions | at 12 months after the procedure | — |
| Stent thrombosis by ARC definition | at 12 months after the procedure | — |
| Lesion success | during the procedure | When the final residual lesion stenosis is less than 30% using any surgical method. |
| Procedure success | immediately after the procedure | When the final residual lesion stenosis is less than 30% 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
Contacts
Primary ContactYoungJin Youn
Outcome results
None listed