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

NCT ID: NCT06168305

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2028-02-28

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.

Conditions

Percutaneous Coronary Intervention; Multivessel Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

GENOSS® DES Sirolimus Eluting Coronary Stent System

Intervention Type: 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.

Interventions

GENOSS® DES Sirolimus Eluting Coronary Stent System

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.)

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genoss Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Korea University GURO Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

2023GR0399

Identifier Type: -

Identifier Source: org_study_id