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

Recruiting

• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Dual Antiplatelet Therapy
• Interventions: Device: Genoss DES stent

• Registration Number: NCT06075433
• Lead Sponsor: Genoss Co., Ltd.

Brief Summary

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.

Study Timeline

• Study Start: 2022-05-13
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-21
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
complex coronary artery disease	Genoss DES stent	\<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 surgery Left ventricular dysfunction (LVEF \<40%) Severe valve disease Troponin positive acute coronary syndrome \<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 (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)

Primary Outcome Measures

Name	Time	Method
Device-oriented composite endpoint	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 Outcome Measures

Name	Time	Method
Patient-oriented composite endpoint	at 12 months after the procedure	POCE is defined as a composite of all-cause death, any myocardial infarction, and any revascularization.
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-realted myocardial infarction (TV-MI)	at 12 months after the procedure
Any revascularization	at 12 months after the procedure
Revascularization of clinically appropriate target lesions	at 12 months after the procedure
Stent thrombosis by ARC definition	at 12 months after the procedure
Lesion success	during the procedure	When the final residual lesion stenosis is less than 30% using any surgical method.
Procedure success	immediately after the procedure	When the final residual lesion stenosis is less than 30% using any surgical method, and there is no post-procedure death, myocardial infarction, or revascularization during the hospitalization period.

Trial Locations

Locations (1)

Wonju Severance Christian Hospital; 🇰🇷 Wŏnju, Gangwon state, Korea, Republic of