A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study
试验速览
- 阶段
- 1 期
- 入组人数
- 120
- 试验地点
- 21
- 主要终点
- MACE
研究概览
简要总结
Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Randomized Cohort: Requires CABG surgery with a SVG to the right coronary artery (RCA) system AND the left circumflex artery (LCX) system with a ≥ 70% stenosis in each of the two systems.
- •Single Vessel Cohort: Requires CABG surgery with a SVG to the RCA system or the LCX system with a > 70% stenosis in the system.
- •Medial sternotomy with cardiopulmonary bypass (CPB) during surgery.
- •Both saphenous vein graft length are adequate for planned intervention, vein outer diameter is between 3.6 mm and 7.0 mm and double wall thickness less than 1.4 mm.
- •Agreement to post-procedure follow-up contact and testing (including follow-up coronary angiogram).
排除标准
- •Concomitant non-CABG cardiac procedure.
- •Prior cardiac surgery (does not include percutaneous procedures).
- •Cerebrovascular or transient ischemia attack within 30 days of the CABG procedure.
- •Age > 85 years.
- •Left ventricular ejection fraction ≤ 35%.
- •Creatinine > 133 μmol/L (1.5 mg/dL) prior to CABG procedure or on chronic dialysis.
- •STEMI within 7 days or total CK > 2 times the upper limit of normal prior to the CABG procedure.
- •Both enrolled grafts will feed non-viable myocardial territory.
- •Diffuse atherosclerotic disease (> 70%) distal to either of the enrolled target coronary arteries.
- •Randomized Cohort: By visual estimate, the target coronary artery diameter of both the right coronary system and left circumflex system must be within 1.5mm of each other.
- •Planned endarterectomy of the target coronary artery.
结局指标
主要结局
MACE
时间窗: 30 days
The rate of major adverse coronary events (MACE) defined as the rate of the composite of total mortality, MI (Q wave and non Q wave), and/or coronary target vessel revascularization (percutaneous coronary intervention or CABG).
Technical success implanting eSVS Mesh
时间窗: intra-operative
Technical success defined as successful placement of the eSVS Mesh on the saphenous vein and surgical implantation of the SVG.
SVG patency determined by angiography
时间窗: 6 months
Angiographic patency rate of the enrolled grafts defined as \< 50% stenosis.
次要结局
- MACCE and mediastinitis(5 years)
- SVG patency determined by angiography(6 months)
- Plaque burden(6 months)