A Retrospective, Multicenter, Post-marketing Clinical Study to Evaluate the Long-term Efficacy and Safety of Coronary Artery Drug-Coated Balloon Dilatation Catheter in the Treatment of In-Stent Restenosis or De Novo Coronary Artery Lesions
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- DK Medical Technology (Suzhou) Co., Ltd.
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- the incidence of Target Lesion Failure (TLF).
概览
简要总结
This clinical trial adopts a retrospective, multicenter design with data registered and collected via an Electronic Data Capture (EDC) system. A total of 252 eligible subjects will be enrolled in the trial, who are consecutively selected in accordance with the inclusion and exclusion criteria from 2022 to the end of 2023 in a retrospective manner. Data collection will be conducted at four time points for all enrolled subjects, including the screening period, 6 months (±30 days) after surgery, 12 months (±30 days) after surgery, and 24 months (±60 days) after surgery. Relevant data of retrospective subjects will be obtained by reviewing medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥18 years old, regardless of gender;
- •Presence of symptomatic coronary heart disease or objective clinical evidence of myocardial ischemia;
- •Treated with DCB for one of the following lesions: in-stent restenosis (any stent type) or de novo lesions with a reference vessel diameter of ≥2.0 mm and ≤2.75 mm.
排除标准
- •Residual stenosis \>30% after pre-treatment with type C or higher dissection;
- •A history of cardiogenic shock;
- •Severe congestive heart failure or NYHA class IV severe heart failure;
- •Pregnant or lactating women;
- •Life expectancy ≤24 months (e.g., patients with extensive metastatic malignant tumors).
研究组 & 干预措施
treatment group
Coronary Artery Drug-Coated Balloon Dilatation Catheter
干预措施: Coronary Artery Drug-Coated Balloon Dilatation Catheter (Device)
结局指标
主要结局
the incidence of Target Lesion Failure (TLF).
时间窗: 24 months
The percentage of subjects who experience TLF from the treatment of the target lesion with the investigational device to 24 months after surgery among the total number of subjects. TLF is defined as a composite endpoint of cardiac death, target vessel myocardial infarction (Q-wave or non-Q-wave MI), and clinically driven target lesion revascularization (CD-TLR).
次要结局
- Device usage(Immediately after the treatment)
- Surgical success rate(Immediately after the treatment)
- Incidence of stent thrombosis(24 months)
- Incidence of device-related cardiovascular events (DoCE)(24 months)
- Incidence of patient-related cardiovascular events (PoCE)(24 months)