A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of GENOSS DES in Patients with Coronary Artery Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Genoss Co., Ltd.
- Enrollment
- 1022
- Locations
- 1
- Primary Endpoint
- Device-oriented composite endpoint
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Device-oriented composite endpoint
Time Frame: 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 Outcomes
- Patient-oriented composite endpoint(at 12 months after the procedure)
- 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)
- Procedure success(immediately after the procedure)