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 (GENOSS-MV)

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: Recruiting
• Conditions: Percutaneous Coronary Intervention; Multivessel Coronary Artery Disease
• Intervention / Treatment: Device: Genoss DES

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 Contact: Name: SeungWoon Rha; Phone Number: 010-8721-0459; Email: swrha617@yahoo.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Recruiting
    • Korea University Guro Hospital
    • Contact: SeoungWoon Rha

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Multivessel coronary artery disease treated with percutaneous coronary intervention using GENOSS stent.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

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 (Estimated): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

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