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.
Study Type
OBSERVATIONAL
Enrollment
3,000
Ulsan University Hospital
Ulsan, South Korea
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
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