The eSVS(TM)Mesh External Saphenous Vein Support Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Primary Efficacy Endpoint: The primary endpoint of the trial is percent stenosis of Study Vessels, assessed by angiography at 12 months following surgery
研究概览
简要总结
Prospective, multi-center, randomized, controlled (patients as their own control) trial on an external mesh device (eSVS™, Kips Bay Medical) supporting saphenous vein grafts for coronary bypass graft surgery in patients with multi-vessel coronary heart disease.
详细描述
The objective of the eSVS™ Mesh Saphenous Vein Support Trial is to prospectively evaluate the clinical safety and efficacy of the eSVS™ Mesh for the treatment of Saphenous Vein Graft (SVG) Coronary artery bypass grafting (CABG) versus SVG CABG without an eSVS™ Mesh.
The eSVS™ Mesh External Saphenous Vein Support Trial is a prospective, multi-center, randomized, controlled trial enrolling up to 120 patients with multi-vessel coronary artery disease who require SVG CABG of the Right Coronary Artery and the Circumflex Artery due to atherosclerotic coronary artery disease. Patients will serve as their own control (patients will be randomized to either:
- SVG+eSVS™ Mesh at Right Coronary Artery and SVG at Circumflex Artery or
- SVG at Right Coronary Artery and SVG+eSVS™ Mesh at Circumflex Artery).
Clinical follow-up assessments consisting of a physical exam, laboratory testing, medication review, and adverse event monitoring for all enrolled patients will be performed at 30 days, 6 months and 12 months. In addition, the 12 month follow-up assessment will include angiography.
The investigational device being evaluated in this clinical trial is an External Saphenous Vein Support device, the eSVS™ Mesh.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •require on-pump SVG CABG of the Right Coronary Artery and the Circumflex Artery due to atherosclerotic coronary artery disease, with ≥ 75% stenosis in each of these vessels
- •have appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and a lack of calcification at the anastomotic site
- •are able to give their informed written consent
- •are ≥ 21 years of age
排除标准
- •no appropriate target coronary vessel
- •discreet attachment of each SVG to the aorta is not possible (non-consecutive or "jump" grafts are excluded)
- •concomitant non-CABG cardiac procedure
- •prior peripheral vascular or cardiac surgery
- •prior stroke
- •history of atrial fibrillation
- •diffuse peripheral vascular disease
- •LVEF < 30% at time of enrollment
- •Insulin-dependent diabetes
- •concurrent participation in another trial
- •concomitant life-threatening disease likely to limit life expectancy to less than 2 years
- •contra-indications to on-pump CABG with cardioplegic arrest (calcified aorta, calcified coronaries, small target vessels)
- •emergency CABG surgery
- •inability to tolerate or comply with normal post-surgical drug regimen (antiplatelet plus statin)
- •taking warfarin or clopidogrel at the time of surgery
- •inability to comply with required follow-ups, including angiography imaging methods
- •patient is pregnant or intends on becoming pregnant in the next 12 months
结局指标
主要结局
Primary Efficacy Endpoint: The primary endpoint of the trial is percent stenosis of Study Vessels, assessed by angiography at 12 months following surgery
时间窗: 12 months
Primary Safety Endpoint: The occurrence of the composite of total mortality, stroke, MI (Q wave and non-Q wave), or coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention) at 30 days post surgery
时间窗: 12 months
次要结局
- The occurrence of the composite of total mortality, stroke, MI (Q wave and non-Q wave), or coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention) at discharge, 6 months and 12 months post surgery(12 months)
- Per-patient incidence of vein graft failure/occlusion(12 months)
- Per-graft incidence of vein graft failure/occlusion(12 months)
- Rates of graft failure due to characterization of anastomotic site failure vs. graft failure(12 months)