Sequent Please Neo Extended Post-Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,040
- 试验地点
- 48
- 主要终点
- Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events)
研究概览
简要总结
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Sequent Please Neo to meet EU Medical Device regulation (MDR) requirements in all the consecutive patients treated with Sequent Please Neo.
详细描述
The objective of this multicenter, prospective, non-randomized, postmarket clinical follow-up(PMCF) study is to confirm and support the clinical safety and performance of the Sequent Please Neo in a NON-SELECTED, Real Word population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device Regulation requirements for post-market clinical follow-up.
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
- •Patients treated with Sequent please neo according to routine hospital practice and following instruction for use.
- •Informed Consent Signed.
排除标准
- •Patient life expectancy less than 12 months.
- •Contraindication for antiplatelet therapy.
- •Not meet inclusion criteria.
研究组 & 干预措施
Coronary Artery Disease (CAD)
干预措施: Sequent Please Neo (Device)
结局指标
主要结局
Safety & Effectiveness. Freedom from MACE (Major Adverse Cardiac Events)
时间窗: 12 months
Composite endpoint of death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR)
次要结局
- Freedom from MACE in the subgroup of Native vessel lesions(12 months)
- Freedom from MACE in the subgroup of Lesions In-stent Restenosis(12 months)
- Freedom from MACE in the subgroup of Lesions in Bifurcation Side Branches(12 months)
- Procedural success(Immediately after PCI (Percutaneous Coronary Intervention))