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 Procedure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Multicenter, Observational Study 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 Procedure
Overview
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.
Primary outcome measures
- Device-oriented composite endpoint [Time frame: at 12 months after the procedure]
Secondary outcome measures (11)
- Patient-oriented composite endpoint [Time frame: at 12 months after the procedure]
- All-cause deaths [Time frame: at 12 months after the procedure]
- Cardiac death [Time frame: at 12 months after the procedure]
- Non-cardiac death [Time frame: at 12 months after the procedure]
- Any myocardial infarction [Time frame: at 12 months after the procedure]
- Target vessel-realted myocardial infarction (TV-MI) [Time frame: at 12 months after the procedure]
- Any revascularization [Time frame: at 12 months after the procedure]
- Revascularization of clinically appropriate target lesions [Time frame: at 12 months after the procedure]
- Stent thrombosis by ARC definition [Time frame: at 12 months after the procedure]
- Lesion success [Time frame: during the procedure]
- Procedure success [Time frame: immediately after the procedure]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
South Korea · 1 center
- Wonju Severance Christian Hospital — Wŏnju
Identifiers
NCT: NCT06075433 · CIP-DS0501-14