NCT06168305Enrolling by invitation
Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease
Safety and Effectiveness of GENOSS® DES (Sirolimus-eluting Coronary Stent System) in Patients With Multivessel Coronary Artery Disease (MVCAD): A Multicenter, Prospective, Observational Study
Source: ClinicalTrials.gov · Last updated 6 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 28 Nov 2023
- Start date
- 15 Nov 2023
- Primary completion date
- 28 Feb 2028
- Lead sponsor
- Genoss Co., Ltd.
- Diseases
- Coronary artery disease
- NCT number
- NCT06168305
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 15 Nov 2023 to the primary completion date, 28 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- \<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
Age in the registry: 19 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.