Safety and Efficacy of Paclitaxel-coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With De Novo Lesion of Small Coronary Artery Disease: A Prospective, Multi-center, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Target lesion failure (TLF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Target lesion failure (TLF)
时间窗: at 1 year after the procedure
composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization
次要结局
- Target lesion failure (TLF)(at 2, 3 years after the procedure)
- Major cardiac adverse events (MACE)(at 1, 2, 3 years after the procedure)
- all mortality(at 1, 2, 3 years after the procedure)
- any MI(at 1, 2, 3 years after the procedure)
- 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)