Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease

• Conditions: Percutaneous Coronary Intervention; Multivessel Coronary Artery Disease

• Registration Number: NCT06168305
• Lead Sponsor: Genoss Co., Ltd.

Brief Summary

The investigators intend to establish a multicenter prospective observational study by enrolling and tracking patients with multivessel coronary artery disease (MVCAD) using Genoss DES, a device manufactured with pure domestic technology. The study aims to evaluate the efficacy and safety of Genoss DES in MVCAD patients.

Detailed Description

This study is a sponsor-driven clinical trial (SIT) that aims to enroll patients who have undergone treatment for multivessel coronary artery disease using Genoss stents. The study involves collecting data on the clinical and surgical processes of patients and tracking the occurrence of clinical events.

This prospective, multicenter observational study registers patients with acute coronary artery disease who have been treated with GENOSS stents at a total of 8 institutions.

As it is an observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants during the study registration period.

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-13
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-30
• Last Update Posted: 2025-10-06
• Primary Completion: 2028-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	at 12 months after the procedure	The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization)

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE)	at 12 months after the procedure	The composite end point of death, myocardial infarction, target lesion revascularization
Cardiac death	at 12 months after the procedure
Non-cardiac death	at 12 months after the procedure
TV-MI (target vessel-myocardial infarction)	at 12 months after the procedure
Non-target vessel myocardial infarction	at 12 months after the procedure
ID-TVR (ischemia-driven target vessel revascularization)	at 12 months after the procedure
Non-ischemia driven target vessel revascularization	at 12 months after the procedure
Incidence rate of acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year	within 24 hours, 30 days, 1 year	Acute (within 24 hours), subacute (within 30 days), late (within 1 year)
Device success	during the procedure	The clinical device is successfully delivered to the target lesion, inflated normally, and recovered intact.
Procedure success	during the hospitalization period (up to 3 days)	When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedural death, myocardial infarction, or revascularization during the hospitalization period.

Trial Locations

Locations (1)

Korea University GURO Hospital; 🇰🇷 Seoul, Seoul, South Korea