The Clinical Effect of No-touch Vein Harvesting Technique in Off-pump Coronary Artery Bypass Graft
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- short-term patency rate of vein grafts
研究概览
简要总结
This study aims to investigate the clinical effect of the new saphenous vein harvesting technique "No-touch" in off-pump coronary artery bypass grafting(OPCABG), comparing to the conventional technique. Adopting CTA to evaluate the 3 months patency of the graft, we will compare veins harvested using No-touch technique to saphenous veins using conventional open technique.
详细描述
Coronary artery disease(CAD) is a widespread health issue around the world. It is proven that atherosclerosis is a inflammatory disease, and endothelial dysfunction is one of the key factors that initiates the inflammatory response. Accumulating studies indicate that endothelial homeostasis plays a primordial role in the development of atherosclerosis.
Coronary artery bypass grafting(CABG) is the standard treatment of three-vessel or left main coronary artery disease, and its long-term benefits is apparent. Saphenous vein is the most common graft in CABG, however, the long-term patency is only about 50% in one year, as a result, it is urgent to discover a solution to improve the long term potency of vein grafts.
Conventional harvesting technique dissects the perivascular tissue and inject saline to check leakage, which causes damages to the endothelium of the vein, initiating inflammatory response. No-touch technique is a atraumatic, non-distended harvesting technique. According to the criteria, we will randomize the patients into two groups, the conventional and No-touch group, the vein will be used in sequential anastomosis, by comparing the 3 months patency rate assessed by CTA, we aim to compare the clinical outcomes of the two different vein harvesting techniques.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients from northern China
- •first time isolated off-pump coronary artery bypass graft
- •echocardiogram show that ejection fraction is over 35%
- •the diameter of saphenous vein ≥ 2mm
- •the vein graft will be used in sequential anastomosis, and the anastomosis sites ≥2
- •be able to sign informed consent form
排除标准
- •patients who need to undergo urgent surgery
- •Severe renal insufficiency(creatinine >200 umol/L)
- •allergic to radiocontrast agent
- •vein is used to isolated anastomosis
- •Combined with malignant tumor or other severe systemic conditions
结局指标
主要结局
short-term patency rate of vein grafts
时间窗: 3 months after surgery
the patency of vein grafts will be assessed by CTA, the doctors of CT department will be masked, at least 2 doctors will provide their conclusions.when the results is controversial, the third doctor will be asked to review the image and provide another conclusion, the patency will be assessed according all results.
次要结局
- CCS grade(3 months and 12 months after surgery)
- long-term patency rate of vein grafts(12 months after surgery)
- major adverse cardiac and cerebrovascular events(MACCE) rate(3 months and 12 months after surgery)
- the healing of the lower leg incision(3 months and 12 months after surgery)
研究者
Zheng Ju-bing
Clinical investigator
Beijing Anzhen Hospital