Efficacy and Safety of GENOSS® DES in Patients with Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT06066476
- Lead Sponsor
- Genoss Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1022
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 target vessel-related myocardial infarction (TV-MI) at 12 months after the procedure 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.
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.
Trial Locations
- Locations (1)
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of