A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of Short Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Genoss Co., Ltd.
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Device-oriented composite endpoint
Study Overview
Brief Summary
The objective of study is to evaluate the efficacy and safety of short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.
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 short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.
The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of short duration of DAPT (3 months for SCAD, 6 months for ACS) after Genoss DES implantation in patients with coronary artery disease from 6 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. 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients of 19 and over
- •Patients with coronary artery disease treated with GENOSS SES
- •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
- •Patients with cardiogenic shock at the time of hospitalization
- •Patients who are pregnant or planning to become pregnant
- •Patients with a life expectancy of less than 1 year
- •Patients participating in randomized controlled trials using other medical devices
- •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)
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)
- Non-cardiac death(at 12 months after the procedure)
- Any revascularization(at 12 months after the procedure)
- All-cause deaths(at 12 months after the procedure)
- Any myocardial infarction(at 12 months after the procedure)
- Cardiac death(at 12 months after the procedure)
- Target vessel-realted myocardial infarction (TV-MI)(at 12 months after the procedure)
- Clinically indicated target lesion revascularization (TLR)(at 12 months after the procedure)
- Stent thrombosis by ARC definition(at 12 months after the procedure)
- Lesion success(during the procedure)
- Procedure success(immediately after the procedure)