NCT01254487已完成不适用
A Postmarket Surveillance Registry of the BioMatrix Drug-eluting Stent
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,121
- 试验地点
- 9
- 主要终点
- Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization
研究概览
简要总结
The purpose of the e-BioMatrix PMS registry is to capture clinical data of the BioMatrix (Biolimus A9-Eluting) stent system in relation to safety and effectiveness.
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
- •Age ≥18 years
- •Patients that need a treatment with a BioMatrix™ drug-eluting stent
- •Presence of one or more coronary artery stenoses in a native coronary artery or a saphenous bypass graft from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents
- •No limitation on the number of treated lesions, and vessels, and lesion length
排除标准
- •Inability to provide informed consent
- •Patients needing additional stent NOT of the BioMatrix™ type
- •Patients receiving next to the BioMatrix™ stent also other coronary vascular interventions, for example dilation.
结局指标
主要结局
Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization
时间窗: 12 Months
次要结局
- Primary and secondary stent thrombosis (definite and probable according to ARC definitions)(30 days, 6 and 12 months, 2, 3 and 5 years)
- Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization(30 days, 6 months, 2, 3 and 5 years)
- Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any clinically driven target vessel revascularization(30 days, 6 and 12 months, 2, 3 and 5 years)
- Total revascularization rate (clinically and non clinically driven)(30 days, 6 and 12 months, 2, 3 and 5 years)
- Death and MI(30 days, 6 and 12 months, 2, 3 and 5 years)
研究者
研究点 (9)
Loading locations...
相似试验
已完成
不适用
e-BioMatrix PostMarket RegistryCoronary Artery DiseaseNCT01289002Biosensors Europe SA5,652
已完成
4 期
A post-marketing surveillance registry of the BioMatrix coronary stent in diabetic patients.CTRI/2011/10/002088Biosensors Europe SA Morges Switzerland1,000
已完成
4 期
A post-market surveillance registry of the BioMatrix coronary stentCTRI/2012/05/002657Biosensors Europe SA Moges Switzerland4,000
招募中
不适用
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 DiabetesType 1 DiabetesNCT06144554Insulet Corporation2,200
已完成
不适用
External Ventricular Drainage Post-Market Clinical Follow-up RegistryDisorder CerebrospinalNCT05652296Integra LifeSciences Corporation120