RECORD-DCB: Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- TLF at 1 year
研究概览
简要总结
The primary aim of this registry is to systematically collect and analyze real-world data on all patients undergoing PCI with the Protégé paclitaxel-eluting DCB to evaluate procedural outcomes, long-term efficacy, and safety across various clinical indications. This registry aims to assess the clinical effectiveness of DCB therapy across diverse patient populations, including those with stable coronary artery disease (CAD) and acute coronary syndromes (ACS), as well as various lesion subsets, encompassing (but not limited to) in-stent restenosis (ISR), de novo coronary lesions, small vessel disease, bifurcation and calcified lesions, coronary bypass graft lesions, and patients at high risk of bleeding. Additionally, the study aims to identify predictors of success, complications, and optimal treatment strategies to further refine the use of DCBs.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing PCI with the Protégé paclitaxel-eluting DCB
- •Age ≥ 18 years
- •Presence of a de novo lesion or in-stent restenosis in a native coronary artery or a in a bypass graft and suitable for PCI
- •Reference vessel diameter between 2.0 - 4.5 mm
- •Patient suitable for dual antiplatelet therapy (DAPT)
排除标准
- •Inability to provide informed consent
- •Allergy to paclitaxel
结局指标
主要结局
TLF at 1 year
时间窗: From enrollment to 1 year follow-up
Target Lesion Failure (TLF) at 1 year, defined as a composite of: * Cardiovascular death * Target vessel myocardial infarction (TV-MI) * Clinically driven target lesion revascularization (TLR)
次要结局
未报告次要终点
研究者
Bimmer Claessen
md phd
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
