Korea University Anam Hospital
Seoul, South Korea
NCT Number: NCT06086496
In this study, the investigators evaluated the effectiveness and safety of using the GENOSS® DES, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.
Interested in participating?
Request Info19 year and older
All sexes
Observational
Seoul, South Korea
This study is a sponsor-initiated clinical trial (SIT) that enrolls patients who underwent percutaneous coronary intervention using the GENOSS® DES drug-eluting stent.
As it is a prospective, multicenter, observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants at 7 institutions during the study registration period.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
<Inclusion Criteria>
<Exclusion Criteria>
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
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: during the hospitalization period (up to 3 days)
When the final internal stenosis rate is less than 30% as assessed visually on angiography after the procedure and there is no death, Q-wave myocardial infarction, or urgent revascularization during hospitalization.
Genoss Co., Ltd.
Industry
Evaluation of Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent in Routine Clinical Practice: A Prospective, Single-arm, Multicenter, Observational Study (The GENCOMX Registry)
Acronym: GENCOMX
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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