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
- 15
- 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.
研究组 & 干预措施
eSVS Mesh treated saphenous vein graft
Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system.
干预措施: eSVS Mesh treated saphenous vein graft (Device)
Control saphenous vein graft
Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system.
干预措施: Control saphenous vein graft (Other)
Single Vessel Treatment
Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system.
干预措施: eSVS Mesh treated saphenous vein graft (Device)
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)