Safety and Efficacy of Paclitax Drug Coated Balloon Catheter (Genoss® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study (GENISPIRE Registry)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 260
- 试验地点
- 10
- 主要终点
- Targeted lesion failure
研究概览
简要总结
The purpose of this observational study was to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter in coronary in-stent restenosis (ISR) patients.
The primary endpoint was target lesion failure (TLF, a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months.
详细描述
260 subjects treated with a paclitaxel-coated balloon (Genoss® DCB) in patients with coronary in-stent restenosis (ISR) will be recruited and followed up to 12 months.
All enrolled patients treated with Genoss DCB in patients with coronary in-stent restenosis (ISR) will be included in the analysis unless there is a valid reason or rationale for it, and the final statistical analysis will follow the intention-to-treat (ITT) principle as assigned. Standard descriptive statistics will be used for patient baseline characteristics, lesions, procedures, and clinical event outcomes. Categorical variables will be presented as percentages and numbers and compared using chi-square or Fisher's exact test. Continuous variables will appear as mean, standard deviation or median, and interquartile range, and will be compared with Student's T-test or Wilcoxon rank sum test, and the normal value of the standard variable distribution will be predicted through histogram, skewness, kurtosis, and Kolmogorov Smirnov one sample test.
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
- •① Age ≥18 years old.
- •② Patients treated with Genoss® DCB in coronary artery In-stent restenosis (ISR) patients.
- •③ Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent.
排除标准
- •A woman who is pregnant, lactating, or planning a pregnancy. ② Patients who are scheduled for surgery requiring discontinuation of antiplatelet drugs within 12 months.
- •Patients with life expectancy less than 1 year.
- •Patients with cardiogenic shock and are predicted to have a low survival rate based on medical judgment.
- •Patients participating in a medical device randomized controlled trials. ⑥ Patients who, in the judgment of the investigator, are not suitable for this clinical study or may increase the risks associated with participation in the study.
结局指标
主要结局
Targeted lesion failure
时间窗: 12 months
A composite of cardiac death, target-vessel MI, or target lesion revascularization
次要结局
- Major adverse cardiovascular events(12 months)
- Any revascularization(12 months)
- Any MI(12 months)
- Any Stroke(12 months)
- Any stent thrombosis(12 months)
- All-cause death(12 months)
- Major bleeding events, BARC 3, 5(12 months)
研究者
Deok-Kyu Cho
Professor, Department of Cardiology, Yongin Severance Hospital, Yonsei University College of Medicine
Yonsei University