Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent (GENOSS® DES)

• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention

• Registration Number: NCT06086496
• Lead Sponsor: Genoss Co., Ltd.

Brief Summary

In this study, the investigators evaluated the effectiveness and safety of using the GENOSS® DES, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.

Detailed Description

This study is a sponsor-initiated clinical trial (SIT) that enrolls patients who underwent percutaneous coronary intervention using the GENOSS® DES drug-eluting stent.

As it is a prospective, multicenter, observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants at 7 institutions during the study registration period.

Study Timeline

• Study Start: 2022-07-15
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-17
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-30
• Last Update Posted: 2025-10-06
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

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
All deaths	at 12 months after the procedure
Cardiac death	at 12 months after the procedure
TV-MI (target vessel-myocardial infarction)	at 12 months after the procedure
any MI (myocardial infarction)	at 12 months after the procedure
ID-TVR (ischemia-driven target vessel revascularization)	at 12 months after the procedure
ID-TLR (ischemia-driven target lesion revascularization)	at 12 months after the procedure
Stent thrombosis by ARC definition	at 12 months after the procedure
Procedure success	during the hospitalization period (up to 3 days)	When the final internal stenosis rate is less than 30% as assessed visually on angiography after the procedure and there is no death, Q-wave myocardial infarction, or urgent revascularization during hospitalization.

Trial Locations

Locations (1)

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