Impact of Drug-Coated Balloon Procedural Factors on Angiographic and Clinical Outcomes of Percutaneous Coronary Intervention for De Novo Lesions: A Multicenter, Prospective, Observational Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 7
- 主要终点
- Target Lesion Restenosis
研究概览
简要总结
This registry aimed to investigate drug-coated balloon procedural factors (particularly delivery time and inflation duration) to evaluate the impact on angiographic and clinical outcomes in patients undergoing percutaneous coronary intervention for de novo coronary lesions.
详细描述
This study aimed to systematically investigate drug-coated balloon procedural factors including Y-to-B delivery time, inflation duration among patients with de novo coronary lesions undergoing PCI.The impact of these procedural factors on angiographic and clinical outcomes will be analyzed.Based on these findings, novel techniques and pretreatment strategies may be proposed to optimize the DCB treatment process
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Stable coronary artery disease or unstable angina
- •De novo coronary lesion (reference vessel diameter 2.25-4.0 mm; lesion length ≤40 mm)
- •Planned DCB strategy for PCI
- •Written informed consent
排除标准
- •Acute myocardial infarction within 72 hours
- •Severe heart failure (NYHA class IV)
- •Severe hepatic or renal insufficiency
- •Allergy to drug-coated balloon components or antiplatelet agents, or intolerance to dual antiplatelet therapy
- •Life expectancy <12 months
- •Pregnancy or breastfeeding
- •Concurrent participation in another clinical trial
- •In-stent restenosis
- •Unsuccessful recanalization of main vessel or side branch chronic total occlusion
- •Hemodynamic instability
研究组 & 干预措施
DCB-Treated De Novo Lesion
Patients undergoing drug-coated balloon treatment for de novo coronary lesions
结局指标
主要结局
Target Lesion Restenosis
时间窗: 6-12 months
Percentage diameter stenosis at the target lesion as assessed by angiography at follow-up
Number of Participants with Target Lesion Restenosis
时间窗: 6-12 months
Percentage diameter stenosis at the target lesion as assessed by angiography at follow-up
次要结局
- Target Vessel Failure(6-12 months)
- Number of Participants with Target Vessel Failure(6-12 months)
研究者
Ye-fei
chief physician
Nanjing First Hospital, Nanjing Medical University