German-Austrian Register to Evaluate the Short and Long-term Safety and Therapy Outcomes of the ABSORB Everolimus-eluting Bioresorbable Vascular Scaffold System in Patients With Coronary Artery Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,330
- 试验地点
- 81
- 主要终点
- Number of serious adverse cardiac events
研究概览
简要总结
The German-Austrian ABSORB Register shall provide an analysis of acute and long-term safety as well as therapy outcomes of the ABSORB (trade mark) bioresorbable vascular scaffold system in patients suffering from coronary artery disease.
详细描述
The register collects prospective data regarding the quality of care of this therapy concept including specifically the following objectives:
- Documentation of all consecutive patients having been treated with the ABSORB biore-sorbable vascular scaffold system under clinical real-world conditions
- Documentation of indications, procedural results, and short and long-term outcomes
- Documentation of the technical performance of ABSORB implant procedures
- Collection of safety data, in particular documentation of hospital mortality, major non-fatal complications (especially myocardial infarction, Re-PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting), stroke, thrombosis)
- Documentation of long-term patient safety marked by mortality and major non-fatal complications (especially myocardial infarction, Re-PCI or CABG, stroke, thrombosis) at 30 days, 6 months, 2 years and 5 years
- Gathering of health economics data (capture of direct costs, especially with view to change of medication and outpatient/inpatient hospital services, and indirect costs) pre and post ABSORB implant
- Gathering data on the quality of life pre and post ABSORB implant to document individual QoL dimensions as well as QALY (quality adjusted life year) data
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •ABSORB implant scheduled
- •Patients giving consent to keep scheduled follow-ups
- •Signed informed consent
排除标准
- 未提供
结局指标
主要结局
Number of serious adverse cardiac events
时间窗: 5 years after index procedure
The following events will be evaluated: * Death * Myocardial infarction * Clinically motivated target vessel revascularization * Clinically motivated target lesion revascularization * Composite target parameter of the aforementioned events (MACE, major adverse cardiac event) as the primary target parameter * Stroke * Composite target parameter of the aforementioned events including stroke as the primary target parameter (MACCE, major adverse cardiac and cerebrovascular event) * Stent thrombosis
次要结局
- Success of ABSORB implantation(during implantation of ABSORB scaffold)