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

Percutaneous Coronary Intervention Clinical Trial

— GENOSS-MV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168305
• Other study ID #: 2023GR0399
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: February 28, 2028

Study information

• Verified date: December 2023
• Source: Genoss Co., Ltd.
• Contact: SeungWoon Rha
• Phone: 010-8721-0459
• Email: swrha617[@]yahoo.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 28, 2028
• Est. primary completion date: February 28, 2028
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adults aged 19 years and older
• Individuals with multivessel coronary artery disiease(MVCAD), including those with recurrent lesions at the procedure site, such as neo-atherosclerotic lesions.
• Participants who have undergone percutanoeus coronary intervention (PCI) with genoss stnets
• Participants who have agreed to the trial protocol and clinical follow-up plan, have voluntarily decided to participate in this clinical trial, and have provided written consent in the informed consent form for trial participation. (Note: Foreign participants must be fluent in Korean and capable of understanding Korean documents, including the informed consent form, to be included.

Exclusion Criteria:

• Trial participants with known hypersensitivity or contraindications to the following drugs or substances: Heparin, Aspirin, Clopidogrel, Cilostazol, Contrast agents (Note: Even participants with hypersensitivity to contrast agents may be eligible for enrollment if their sensitivity can be controlled by steroids and antihistamines; however, those with known anaphylaxis are excluded).
• Cases where balloon expansion is unsuccessful during balloon angioplasty at the stenotic site.
• Participants with an expected residual lifespan of less than one year.
• Those who are planning to become pregnant, pregnant, or breastfeeding.
• Participants who presented with cardiogenic shock during hospitalization and are predicted to have a low likelihood of survival based on medical judgment.
• Individuals deemed unsuitable for this clinical trial or those for whom participation may increase risks related to trial involvement, as determined by the investigator.
• Foreign participants who cannot fluently speak Korean and have difficulty understanding Korean documents.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Multivessel Coronary Artery Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Device:
• Genoss DES
The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

Locations

Country	Name	City	State
Korea, Republic of	Korea University GURO Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genoss Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	device-oriented composite end point	A composite index of cardiac death, any myocardial infarction not clearly attributable to a non-target vessel, and target-lesion revascularization.	12 months
Secondary	Number of participants with patient-oriented composite endpoint	Target lesion treatment failure up to 1 years after stent insertion; Failure of target vessel treatment up to 1 years after stent insertion (cardiogenic · death, myocardial infarction, target vessel revascularization (TVR); All cause death up to 1 years after stent insertion; Cardiac death up to 1 years after stent insertion; All-cause mortality and myocardial infarction up to 1 years after stent insertion; Cardiogenic death and myocardial infarction up to 1 years after stent insertion; Target vessel revascularization up to 1 years after stent insertion; Target lesion revascularization up to 1 years after stent insertion; Occurrence of stent thrombosis up to 1 years after stent insertion; Device success; Procedure success	12 months