Registry of Patients With Bioresorbable Device in Daily Clinical Practice. REPARA Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,440
- 试验地点
- 1
- 主要终点
- MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven: Cardiac Death/All MI/ID-TLR
研究概览
简要总结
A multicentre, observational, prospective device registry, with no control group, designed to evaluate the efficacy and safety of the bioresorbable coronary device, used according to the indications of use, in daily clinical practice in a consecutive number of patients undergoing PCI in de novo coronary artery lesions. A total of 1,500 patients are planned to be included in the registry.
详细描述
The patients will be included consecutively at each site for one year. They will be individuals from both sexes, requiring endovascular intervention and meeting the authorised criteria for the indications of use of the device to be used and where dual anti-platelet therapy (DAPT) with aspirin and thienopyridines is considered.
STUDY OBJECTIVES To evaluate the MACE rate after implantation of the bioresorbable coronary device in patients with de novo coronary artery lesions, where a follow-up of 12 months will be performed.
Primary objective:
MACE rate at 12 months of follow-up:
Cardiac death Myocardial infarction TLR driven by ischaemia of the lesion treated or of the region of 5 mm proximally or distally to the site of implantation of the device (ID-TLR).
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
- •Patient must be at least 18 years of age at the time of signing the Informed Consent Form
- •Patient is to be treated for de novo coronary lesions in a native coronary artery and amenable to receive a bioresorbable device
- •The length of the treated lesion should be inferior to the nominal length of the device (12 mm, 18 mm, 28 mm) with a reference vessel diameter > 2 mm y < 3,8 mm.
- •The patient will not have any relative contraindication for double antiplatelet therapy, with aspirin indefinitely and with a thienopyridine for at least 6 months
排除标准
- •Cardiogenic shock
- •Left main disease
- •Aortocoronary graft
- •Intrastent restenosis
- •Potentially child-bearing women with no contraceptive methods
- •Pregnant or breast-feeding women
结局指标
主要结局
MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven: Cardiac Death/All MI/ID-TLR
时间窗: Clinical follow-up at 12 months
次要结局
- Immediate success of the device/procedure(1 day)
- Cardiac death(12 months)
- Scaffold/Stent Thrombosis: Timing and Evidence(12 months)
- Myocardial infarction(12 months)
- Target lesion/vessel revascularization (TLR/TVR)(12 months)
- Angina Events(12 months)
- Rate of patients with DAPT at 12 months(12 months)
- Rate of overlapping devices and characteristics(12 months)