An observational study in Coronary Artery Disease(CAD), sponsored by Genoss Co., Ltd.. Enrolling by invitation at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Genoss Co., Ltd. · Observational
The GENOSS PCB-De Novo study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin E excipients (Genoss® DCB) in patients with De novo small coronary artery disease.
This prospective, open-label, multicenter, observational study will enroll patients with de novo small coronary artery disease undergoing PCI with the GENOSS® DCB at 47 hospitals.
Because this is an observational study, the number of participants will not be calculated separately, but a total of 3,000 participants are planned to be recruited during the study enrollment period.
All patients will be followed up at 1, 2, and 3 years postprocedure to evaluate the safety and efficacy of the paclitaxel-coated PTCA balloon catheter.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Genoss Co., Ltd. is the lead sponsor of 18 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects who underwent PCI with GENOSS DCB for small coronary artery disease with de novo lesions
Exclusion Criteria:
If it falls under any of the following items after prior dilation of the target lesion;
Patients with de novo small coronary artery disease who underwent PCI with GENOSS DCB
Target lesion failure (TLF)
composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization
Time frame: at 1 year after the procedure
Target lesion failure (TLF)
composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization
Time frame: at 2, 3 years after the procedure
Major cardiac adverse events (MACE)
composite endpoint of death, myocardial infarction, and revascularization
Time frame: at 1, 2, 3 years after the procedure
all mortality
all deaths and cardiac deaths
Time frame: at 1, 2, 3 years after the procedure
any MI
all myocardial infarction and target vessel myocardial infarction (TV-MI)
Time frame: at 1, 2, 3 years after the procedure
all revascularization and ischemia-driven target lesion revascularization (ID-TLR)
Time frame: at 1, 2, 3 years after the procedure
major bleeding event
BARC 3, 5
Time frame: at 1, 2, 3 years after the procedure
Plan to share: No
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Genoss Co., Ltd.