PCI Registry Basel
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Target Vessel Failure (TVF)
研究概览
简要总结
This registry aims to learn more about the best ways to treat coronary artery disease. Information from routine medical care will be collected to compare different treatment approaches, including drug-eluting stents, drug-coated balloons (DCB), and bioresorbable scaffolds (BRS), which gradually dissolve over time. The registry will include people with coronary artery disease who receive an intervention (percutaneous coronary intervention), including those undergoing more complex procedures. By studying treatment outcomes over time, the Registry aims to better understand which therapies work best for different groups of patients and to improve future care for people with coronary artery disease.
详细描述
The PCI Registry Basel is established to systematically collect real-world data on all patients (≥18 years) undergoing percutaneous coronary interventions (PCI) at the University Hospital Basel. The primary purpose of the registry is to investigate the best treatment strategies in patients with coronary artery disease (CAD) and their associated outcomes in routine clinical practice, including complex procedures (e.g. chronic total occlusions (CTO), bifurcation lesions, left main interventions), the use of drug-coated balloons (DCB) and bioresorbable scaffolds (BRS), as well as standard drug-eluting stent (DES) implantation.
Data are derived retrospectively from routine clinical practice at the University Hospital Basel. Relevant procedural, clinical, and follow-up information is extracted from existing sources such as the catheterization lab reports, and the electronic health record (Cardioapp). No additional data collection or invasive study-specific interventions are performed for the purpose of this registry.
Where applicable, data from previous research projects or registries may also be incorporated, provided that all legal and ethical requirements are satisfied. All data will be pseudonymised before analysis. A secure decoding key linking registry numbers to patient identifiers is kept separately and is accessible only to authorized personnel under the responsibility of the Principal Investigator.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 treated at the University Hospital Basel
- •Undergoing complex PCI (e.g. left main, bifurcation, multivessel PCI, rotational atherectomy or other calcium modification, complex anatomy). The definition complex will be a clinical/ procedural/ anatomical definition made by the operator.
- •Undergoing CTO or CHIP (Complex High-risk Indicated Patient) procedures
- •Treated with a DCB strategy
- •Treated with a BRS
排除标准
- •Patients under 18 years of age
结局指标
主要结局
Target Vessel Failure (TVF)
时间窗: Through study completion, an average of 1 year
Composite endpoint defined as the occurrence of cardiovascular death, target vessel myocardial infarction, or unplanned target vessel revascularisation.
次要结局
未报告次要终点