Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease (NCT06168305) | Clinical Trial Compass
By InvitationNot Applicable
Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease
South Korea1,000 participantsStarted 2023-11-15
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
\<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 th…