Prospective Registry of ihtDEStiny® Coronary Stent in Regular PCI Practice
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 20
- 主要终点
- Death
研究概览
简要总结
Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent.
详细描述
Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent use in real-world percutaneous coronary intervention
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
- •≥18 years old
- •PCI and stent implantation indication according to ESC Myocardial Revascularization Guidelines
- •1 or more stenosis at native coronary anatomy, in a 2-4mm vessel size, where 1 or more ihtDEStiny® drug eluting stent were implanted (or attempted to be implanted).
- •Informed consent signed after PCI
排除标准
- •Patient refusal to participate in the study
- •Pregnancy
- •Other DES implantation during index PCI, or 30 days before of after index PCI
- •PCI at surgical grafts
- •PCI for in-stent restenosis
- •Killip class 3-4 Acute Coronary Syndromes (ACS)
- •High bleeding risk with dual antiplatelet intolerance for at least 3 months (or 6 months for ACS PCI)
- •Allergy or hypersensitivity to sirolimus
- •Patients requiring surgery (cardiac or non-cardiac) in the next 3 months after index PCI
- •Patients with life expectancy <2 years
- •Patients included in other trials or clinical studies
研究组 & 干预措施
Coronary Artery Disease
干预措施: Percutaneous Coronary Intervention (Device)
结局指标
主要结局
Death
时间窗: 2 years
Death
Target Lesion Failure (TLF)
时间窗: 2 years
Rate of target lesion failure
Target vessel myocardial infarction
时间窗: 2 years
Target vessel myocardial infarction
Target lesion revascularization (TLR)
时间窗: 2 years
Target lesion revascularization (TLR)
Cardiovascular Death
时间窗: 2 years
Cardiovascular Death
Target lesion revascularization (TLR)
时间窗: 5 years
Target lesion revascularization (TLR)
Cardiovascular Death
时间窗: 5 years
Cardiovascular Death
Target Lesion Failure (TLF)
时间窗: 5 years
Rate of target lesion failure
Death
时间窗: 5 years
Death
Target vessel myocardial infarction
时间窗: 5 years
Target vessel myocardial infarction
次要结局
- Stent thrombosis(2 years)
- Major Adverse Cardiovascular Event (MACE)(2 years)
- Patient Oriented Composite Event(2 years)
- Device success(During procedure)
- Procedural success(3 days)
- Target Vessel Failure (TVF)(2 years)
- Severe BARC Bleeding(2 years)
- Stent thrombosis(5 years)
- Target Vessel Failure (TVF)(5 years)
- Major Adverse Cardiovascular Event (MACE)(5 years)
- Patient Oriented Composite Event(5 years)
- Severe BARC Bleeding(5 years)