Korea University GURO Hospital
Seoul, 08308, South Korea
NCT Number: NCT06168305
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.
Interested in participating?
Request Info19 year and older
All sexes
Observational
Seoul, 08308, South Korea
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.
Only the study team can determine whether someone qualifies for participation.
<Inclusion Criteria>
(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>
Subject
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.
Time frame: at 12 months after the procedure
The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization)
Time frame: at 12 months after the procedure
The composite end point of death, myocardial infarction, target lesion revascularization
Time frame: at 12 months after the procedure
Time frame: at 12 months after the procedure
Time frame: at 12 months after the procedure
Time frame: at 12 months after the procedure
Time frame: at 12 months after the procedure
Time frame: at 12 months after the procedure
Time frame: within 24 hours, 30 days, 1 year
Acute (within 24 hours), subacute (within 30 days), late (within 1 year)
Time frame: during the procedure
The clinical device is successfully delivered to the target lesion, inflated normally, and recovered intact.
Time frame: during the hospitalization period (up to 3 days)
When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedural death, myocardial infarction, or revascularization during the hospitalization period.
Genoss Co., Ltd.
Industry
Safety and Effectiveness of GENOSS® DES (Sirolimus-eluting Coronary Stent System) in Patients With Multivessel Coronary Artery Disease (MVCAD): A Multicenter, Prospective, Observational Study
Acronym: GENOSS-MV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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