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Enrolling by invitation Observational

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

NCT06168305 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2023-11-15
Last updated
2025-10-06

Condition(s) studied

Percutaneous Coronary InterventionMultivessel Coronary Artery Disease

Investigational drug(s) / intervention(s)

GENOSS® DES Sirolimus Eluting Coronary Stent System

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.

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
\<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

Primary outcome measure(s)

  • 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)

Trial sites (1)

FacilityCityRegionStatus
Korea University GURO Hospital Seoul Seoul
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06168305 on ClinicalTrials.gov ↗ ← All trials in South Korea