Status:
ENROLLING_BY_INVITATION
Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease
Lead Sponsor:
Genoss Co., Ltd.
Conditions:
Percutaneous Coronary Intervention
Multivessel Coronary Artery Disease
Eligibility:
All Genders
19+ years
Brief 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 manuf...
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...
Eligibility Criteria
Inclusion
- \<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
Exclusion
Key Trial Info
Start Date :
November 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06168305
Start Date
November 15 2023
End Date
February 28 2028
Last Update
October 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Korea University GURO Hospital
Seoul, Seoul, South Korea, 08308