European (EU) Multi-Center Registry to Assess Outcomes in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery: Treatment of Vascular Conduits With DuraGraft®, a Novel Endothelial Damage Inhibitor [VASC]
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,964
- 试验地点
- 36
- 主要终点
- Rate of Major Adverse Cardiac Events (MACE)
研究概览
简要总结
The DuraGraft® Registry is a European registry of patients who have undergone CABG and whose vascular grafts have been treated with DuraGraft. All participating sites will be from countries in Europe. The DuraGraft Registry will collect pre-CABG, intraoperative and post-operative data, major post-CABG cardiovascular adverse events, health economic outcomes and patient reported quality of life over a period of 5 years.
详细描述
Objectives:
(i) To evaluate the Safety and Performance of DuraGraft®
(ii) To characterize the use of DuraGraft and the outcomes of patients whose vascular grafts were treated with DuraGraft in daily clinical routine
(iii) To further characterize the incidence of MACCE outcomes associated with CABG in patients whose vascular grafts were treated with DuraGraft in daily clinical routine
(iv) To compare the use of DuraGraft among hospitals and practices
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery with at least one saphenous vein or radial artery grafts
- •Patient is ≥18 years of age
- •Patient (or a legally authorized representative) is willing and able to provide consent
- •DuraGraft is being used for the CABG procedure
排除标准
- •Participation in a device study or receiving active drug product in an investigational study within one month prior to enrollment
结局指标
主要结局
Rate of Major Adverse Cardiac Events (MACE)
时间窗: Annually up to 5 years post-CABG Surgery
Rate of Major Adverse Cardiac Events: MACE (a composite of Death, Non-Fatal Myocardial Infarction and Repeat Revascularization. The rate of MACE will be compared to historical controls.
次要结局
- Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)(1 month post-CABG Surgery)
- Health Economics Outcomes(Annually up to 5 years post-CABG Surgery)
- Quality of life (EQ-5D-5L)(Annually up to 5 years post-CABG Surgery)