Coronary Artery Disease
Conditions
Brief summary
The objective of this study is to evaluate the efficacy and safety of the GENOSS DES in patients with coronary artery disease in real-world pratice.
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 the Genoss DES in all-comer patients undergoing percutaneous coronary intervention. The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss DES implantation in all-comer patients undergoing percutaneous coronary intervention from 12 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 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
\<Inclusion Criteria\> 1. Patients of 19 and over 2. Patients eligible for treatment of coronary artery disease using GENOSSTM DES 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 research 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 | 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 |
|---|---|---|
| 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. |
| 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 | — |
| 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 | — |
| 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. |
| target vessel-related myocardial infarction (TV-MI) | at 12 months after the procedure | — |
Countries
South Korea
Outcome results
None listed