Multinational Abluminal Sirolimus Coated BiO-Engineered StenT - The MASCOT Post Marketing Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- OrbusNeich
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Adjudicated device-oriented composite target lesion failure (TLF)
研究概览
简要总结
To collect post marketing surveillance data on patients receiving at least one Combo Bio-Engineered Sirolimus Eluting Stent when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Combo Stent in routine clinical practice.
详细描述
The multicenter, multinational, prospective registry population consists of patients who undergo percutaneous coronary intervention (PCI) with (attempted) placement of at least one Combo Stent (according to the Instructions for use) as part of routine clinical care. Approximately 2,500 patients from 50 centers in Europe and Asia will be entered into the registry. Patients entered into the registry are followed for one year. The registry is considered finished when all patients have completed the 12 month follow-up.
A follow-up is scheduled at 30 days, 6 months and 12 months post procedure. Follow-up is obtained at a planned regular visit to the outpatient clinic, or by telephone contact with the patient.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Adjudicated device-oriented composite target lesion failure (TLF)
时间窗: 12 months post procedure
Adjudicated device-oriented composite target lesion failure (TLF) defined as a composite of cardiac death, non-fatal myocardial infarction (MI) not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization (TLR) (percutaneous or by coronary artery bypass grafting (CABG)) at 12 months post procedure.
次要结局
- Adjudicated TLF(at index procedure, 30 days, 6 months and 12 months post procedure)
- Each of the components of TLF (Cardiac death, Non-fatal MI not clearly attributable to a non-target vessel, Target lesion revascularization (TLR))(at index procedure, 30 days, 6 months, 12 months)
- Adjudicated patient-oriented composite Major Adverse Cardiac Events (MACE) as a composite of all Death, any MI and ischemia-driven revascularization (TLR/TVR/non-TVR)(at index procedure, 30 days, 6 months and 12 months)
- Each of the components of MACE (All death, Any myocardial infarction, Ischemia-driven revascularization)(at index procedure, 30 days, 6 months and 12 months)
- Adjudicated stent thrombosis per the Academic Research Consortium (ARC) definition(at index procedure, 30 days, 6 months and 12 months post-procedure)
- Adjudicated bleeding per the Bleeding Academic Research Consortium (BARC) definition(at index procedure, 30 days, 6 months and 12 months post-procedure)
- Adjudicated stroke(at index procedure, 30 days, 6 months and 12 months)
- Device success: Percentage of patients with a successful delivery and deployment of the Combo Stent to the target lesion and a final diameter stenosis after stenting ≤20% by visual assessment in the presence of grade 3 TIMI flow, by visual estimation(Index Procedure)
- Procedure success: Successful stent placement and no peri-procedural complications.(Index procedure)