Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GENOSS® DES Sirolimus Eluting Coronary Stent System.
- Who it may be relevant to
- Registry conditions: Percutaneous Coronary Intervention, Multivessel Coronary Artery Disease. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Target Lesion Failure (TLF) [Time frame: at 12 months after the procedure]
Secondary outcome measures (10)
- Major adverse cardiac events (MACE) [Time frame: at 12 months after the procedure]
- Cardiac death [Time frame: at 12 months after the procedure]
- Non-cardiac death [Time frame: at 12 months after the procedure]
- TV-MI (target vessel-myocardial infarction) [Time frame: at 12 months after the procedure]
- Non-target vessel myocardial infarction [Time frame: at 12 months after the procedure]
- ID-TVR (ischemia-driven target vessel revascularization) [Time frame: at 12 months after the procedure]
- Non-ischemia driven target vessel revascularization [Time frame: 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 [Time frame: within 24 hours, 30 days, 1 year]
- Device success [Time frame: during the procedure]
- Procedure success [Time frame: during the hospitalization period (up to 3 days)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
South Korea · 1 center
- Korea University GURO Hospital — Seoul
Identifiers
NCT: NCT06168305 · 2023GR0399