Efficacy and Safety of GENOSS® SES in Patients with Acute Coronary Syndrome (GENOSS ACS)

Active, not recruiting

• Conditions: Percutaneous Coronary Intervention; Acute Coronary Syndrome

• Registration Number: NCT06075368
• Lead Sponsor: Genoss Co., Ltd.

Brief Summary

The objective of this study is to evaluate the efficacy and safety of the GENOSS SES in patients with acute coronary syndrome (ACS) in real-world pratice.

Detailed Description

The Genoss SES 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 the Genoss SES in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention.

The Genoss SES study is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss SES implantation in ACS patients undergoing percutaneous coronary intervention from 10 sites in South Korea. The primary endpoint was a device-oriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 10 months.

Study Timeline

• Study Start: 2020-03-16
• 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: 2025-02-16
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 757

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device-oriented composite endpoint	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
Target lesion failure (TLF)	3 years after the procedure	Target lesion failure (TLF) is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR).
Target vessel failure (TVF)	3 years after the procedure	Target vessel failure (TVF) is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-vessel revascularization (TVR).
All-cause death	3 years after the procedure
Cardiac death	3 years after the procedure
All-cause death and any myocardial infarction	3 years after the procedure
Cardiac death and target vessel-related myocardial infarction	3 years after the procedure
Target lesion revascularization (TLR)	3 years after the procedure
Stent thrombosis	3 years after the procedure
Target vessel revascularization (TVR)	3 years after the procedure

Trial Locations

Locations (1)

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