SUPRAFLEX CRUZPost-Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 508
- 试验地点
- 21
- 主要终点
- Target Lesion Failure (TLF)
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 Medical Device Regulations (MDR) with multivessel coronary disease requirements in all the CONSECUTIVE patients treated with (SUPRAFLEX CRUZ).
详细描述
The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the SUPRAFLEX CRUZ in a NON-SELECTED, Real World 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
- •≥ 18 years old and;
- •Patients treated with SUPRAFLEX CRUZ according to routine hospital practice and following instructions for use
- •Patients with multivessel coronary artery disease (understood as that which affects more than one territory of the major epicardial coronary arteries - anterior descending, circumflex, right coronary artery) who is treated with more than 1 stent under study in lesions located in more than 1 of the aforementioned arteries.
- •Substudy: Patients with Ejection Fraction <45% by Echocardiography
- •Informed consent signed
排除标准
- •Not meet inclusion criteria
- •Contraindication for antiplatelet treatment
- •Patient life expectancy less than 12 months
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 12 months
Rate of target lesion failure
Device-oriented Composite Endpoint (DoCE)
时间窗: 12 months
Device-oriented Composite Endpoint (DoCE) defined as the composite of: Cardiovascular death, target vessel myocardial infarction, clinically indicated repeat revascularization of the target lesion at 12 months
次要结局
- Major Adverse Cardiovascular Event (MACE)(12 months)
- Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography(1 month)
- Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography(1 month)
- Change of segmental movement of the territory revascularized measured by echocardiography(1 month)
- Changes in left ventricular ejection fraction (LVEF)(1 month)