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 (DAPTLong)

Genoss

Status: Enrolling

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Dual Antiplatelet Therapy

Treatments: Device: Genoss DES stent

Study type: Observational

Funder types: Industry

Identifiers

NCT06075433

CIP-DS0501-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,000 participants in 1 patient group

GENOSS Sirolimus Eluting Coronary Stent System

Description:

Patients with coronary artery disease treated with the GENOSS DES \<Definition of a complex high-risk patients\> 1. Clinical factors * Age 75 or older * History of diabetes (those who have had diabetes in the past or are taking diabetes medication) * History of chronic kidney disease (GFR \<60ml/min/1.73m2) or dialysis * History of stroke * History of coronary artery bypass graft * Left ventricular dysfunction (LVEF \<40%) * Severe valve disease * Acute coronary syndrome with positive troponin levels 2. Lesion/procedure factors * Left main lesion * Chronic total occlusion * Bifurcation lesion with branches larger than 2 mm * Calcified lesion (moderate to severe calcified lesion) * Restenosis lesion (in-stent restenosis) * Multivessel PCI * Three or more stents implanted (≥3 stents implanted) * When the stent length of one lesion is more than 50 mm (total stent length \>50 mm in a lesion)