Coronary Artery Disease(CAD)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Genoss Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults over the age of 19 * Patients with new lesions with coronary small vascular disease (vascular diameter \<3.0 mm) underwent a GENOSS® DCB procedure through percutaneous coronary intervention * Subjects who agreed to the clinical research plan and the clinical follow-up plan, voluntarily decided to participate in this clinical study, and agreed in writing to the consent of the study subjects
Exclusion criteria
* Subjects who plan to become pregnant during the period of this study as women of the gestational age * Subjects whose remaining life expectancy is expected to be less than one year * Subjects who visited the hospital due to psychogenic shock at the time of visiting the hospital and are predicted to have a low chance of survival based on medical judgment * If it falls under any of the following items after prior dilation of the target lesion; * Stent procedures are required due to vascular detachment that limits blood flow * If the residual stenosis is \>30% * If the TIMI flow is \<3 * Subjects participating in a randomized study of medical devices * If the researcher determines that it is not appropriate for this clinical study or may increase the risk associated with participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure (TLF) | at 1 year after the procedure | composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major cardiac adverse events (MACE) | at 1, 2, 3 years after the procedure | composite endpoint of death, myocardial infarction, and revascularization |
| all mortality | at 1, 2, 3 years after the procedure | all deaths and cardiac deaths |
| Target lesion failure (TLF) | at 2, 3 years after the procedure | composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization |
| all revascularization and ischemia-driven target lesion revascularization (ID-TLR) | at 1, 2, 3 years after the procedure | — |
| major bleeding event | at 1, 2, 3 years after the procedure | BARC 3, 5 |
| any MI | at 1, 2, 3 years after the procedure | all myocardial infarction and target vessel myocardial infarction (TV-MI) |
Countries
South Korea
Outcome results
None listed