Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease (GENOSS-MV)

Safety and Effectiveness of GENOSS® DES (Sirolimus-eluting Coronary Stent System) in Patients With Multivessel Coronary Artery Disease (MVCAD): A Multicenter, Prospective, Observational Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Percutaneous Coronary Intervention; Multivessel Coronary Artery Disease
• Intervention / Treatment: Device: GENOSS® DES Sirolimus Eluting Coronary Stent System

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 08308
      • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

<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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death		at 12 months after the procedure
Non-cardiac death		at 12 months after the procedure
Major adverse cardiac events (MACE)	The composite end point of death, myocardial infarction, target lesion revascularization	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
ID-TVR (ischemia-driven target vessel revascularization)		at 12 months after the procedure
Non-ischemia driven target vessel revascularization		at 12 months after the procedure
Incidence rate of acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year	Acute (within 24 hours), subacute (within 30 days), late (within 1 year)	within 24 hours, 30 days, 1 year
Device success	The clinical device is successfully delivered to the target lesion, inflated normally, and recovered intact.	during the procedure
Procedure success	When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedural death, myocardial infarction, or revascularization during the hospitalization period.	during the hospitalization period (up to 3 days)

Collaborators and Investigators

• Sponsor: Genoss Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2023GR0399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No