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

Genoss Co., Ltd.1,000 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Coronary Artery Disease Percutaneous Coronary Intervention Dual Antiplatelet Therapy

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients of 19 and over 2. Patients with coronary artery disease treated with GENOSS SES 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 study participants Exclusion Criteria: 1. Patients with cardiogenic shock at the time of hospitalization 2. Patients who are pregnant or planning to become pregnant 3. Patients with a life expectancy of less than 1 year 4. Patients participating in randomized controlled trials using other medical devices 5. 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

DOCE is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR).