Efficacy and Safety of GENOSS SES in Patients with Coronary Artery Disease

Active, not recruiting

• Conditions: Coronary Arterial Disease (CAD)

• Registration Number: NCT06841510
• Lead Sponsor: Genoss Co., Ltd.

Brief Summary

Efficacy and Safety of GENOSS SES in patients with coronary artery disease

Detailed Description

GENOSS SES

Study Timeline

• Study Start: 2018-04-19
• Status Verified: 2025-02
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-24
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1116

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 who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents
2. Patients who are pregnant or planning to become pregnant
3. Patients with a planned surgery to discontinue antiplatelet agents within 12 months
4. Patients with a life expectancy of less than 1 year
5. Patient with cardiogenic shock at the time of hospitalization and had a low chance of survival based on medical judgment.
6. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration
7. Patients participating in randomized controlled trials using other medical devices

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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-related myocardial infarction (TV-MI)	at 12 months after the procedure
Any revascularization	at 12 months after the procedure
Clinically indicated target lesion revascularization (TLR)	at 12 months after the procedure
Stent thrombosis	at 12 months after the procedure
Lesion success	during the procedure	When the final residual lesion stenosis is less than 50% using any surgical method.
Procedure success	immediately after the procedure	When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedure death, myocardial infarction, or revascularization during the hospitalization period.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of