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

NCT06168305 | Enrolling By Invitation

• 1 other identifier: 2023GR0399
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Coronary Intervention; Multivessel Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure (TLF)

  The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization)

  at 12 months after the procedure

Secondary Outcomes (10)

• Major adverse cardiac events (MACE)

  at 12 months after the procedure

• 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

Study Arms (1)

GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]

Patients with multivessel coronary artery disease (MVCAD) who underwent percutaneous coronary intervention using GENOSS® DES

Device: GENOSS® DES Sirolimus Eluting Coronary Stent System

Interventions

GENOSS® DES Sirolimus Eluting Coronary Stent System DEVICE

The GENOSS® DES is L-605 cobalt chromium (CoCr) platform with a strut thickness of 70µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with multivessel coronary artery disease (MVCAD) who underwent percutaneous coronary intervention using GENOSS® DES

You may qualify if:

• Adults over 19 years of age
• Subjects with multivessel coronary artery disease (MVCAD) (However, subject registration is possible even if the treatment area is restenosis or recurrent lesion, including new lesions)
• Subjects who underwent percutaneous coronary intervention (PCI) with GENOSS® DES
• Research subjects who agree to the research protocol and clinical follow-up plan, voluntarily decide to participate in this clinical study, and give written consent in the informed consent form.
• (However, in the case of foreigners, only those who can speak Korean fluently and understand Korean documents such as the consent form are included.)

You may not qualify if:

• Test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded)
• When balloon angioplasty is performed on a stenotic area, the balloon cannot be expanded.
• Those whose remaining life expectancy is less than 1 year
• Expecting to become pregnant, pregnant or lactating woman
• The patient was admitted to the hospital due to cardiogenic shock and was predicted to have a low chance of survival based on medical judgment.
• Subject
• If the researcher determines that the product is not suitable for this clinical study or may increase the risks associated with participation in the study.
• Foreigners who cannot speak Korean fluently and have difficulty understanding Korean documents

Sponsors & Collaborators

• Genoss Co., Ltd.: lead

Study Sites (1)

Korea University GURO Hospital

Seoul, Seoul, 08308, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 13, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)