Post-market Study to Evaluate Post-implant Patency Rates of the External Saphenous Vein Support (eSVS®) Mesh in the Treatment of Saphenous Vein Grafts (SVGs) During Coronary Artery Bypass Grafting (CABG) Versus SVGs Without the eSVS Mesh.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Patency of external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Graft (SVG) versus Control SVG
研究概览
简要总结
The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.
详细描述
The study will enroll up to 200 patients at up to 6 sites. Patients will be enrolled upon meeting entrance criteria, including obtaining written informed consent. Eligible patients must be clinically indicated for coronary artery bypass grafting (CABG) using autologous saphenous vein grafts (SVG). The study is a prospective, randomized, repeated measure controlled trial based on each patient receiving one control SVG and one external Saphenous Vein Support (eSVS) Mesh treated SVG. Each patient will be their own control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been diagnosed with multi-vessel coronary artery disease
- •Requires Saphenous Vein Graft (SVG) Coronary Artery Bypass Graft (CABG) surgery of the Right Coronary Artery (RCA) and the Circumflex Artery (Cx) systems due to atherosclerotic coronary artery disease
- •SVGs (eSVS Mesh AND Control) meet size requirements as outlined in eSVS Mesh Instructions for Use
- •eSVS Mesh implant procedure can be performed as outlined in the eSVS Mesh Instructions for Use
- •Are able to give their informed consent
排除标准
- •Not able to give informed consent
- •No appropriate target coronary vessels
- •SVGs (eSVS Mesh or Control) do not meet size requirements as outlined in eSVS Mesh Instructions for Use
- •eSVS Mesh implant procedure cannot be performed as outlined in the eSVS Mesh Instructions for Use
- •Inability to tolerate or comply with normal post-surgical drug regimen
- •Inability to comply with required follow-up coronary angiography/CT
结局指标
主要结局
Patency of external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Graft (SVG) versus Control SVG
时间窗: 3-6 Months
Patency of eSVS Mesh and Control SVGs assessed by spiral CT or angiography at 3-6 months following surgery.
Patency and percent stenosis of the eSVS Mesh and Control Saphenous Vein Grafts
时间窗: 24 Months
Patency and percent stenosis of the eSVS Mesh and Control SVGs assessed by angiography at 24 months following surgery
The occurrence of any Major Adverse Cardiac Event (MACE)
时间窗: 3-6 months post implant
The occurrence of the MACE composite of death, myocardial infarction (Q wave and non-Q wave), stroke, coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention), and at 3 to 6-months postimplant.
次要结局
未报告次要终点