OPTION Trial: Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Improved vein graft patency
研究概览
简要总结
The purpose of this study is to demonstrate improved vein graft patency rates at 12 months for endoscopically harvested saphenous vein grafts. The study will evaluate use modifications to existing techniques in vein graft handling during harvests. A secondary aim is to develop a standardized approach for harvesting, handling, and preparing vein grafts in the endoscopic approach.
详细描述
Available data supports two facts: 1) Saphenous vein graft failure rates may be as high as 47% per patient at one year post coronary artery bypass grafting, and 2) Endoscopic vein-graft harvesting is independently associated with vein-graft failure and adverse clinical outcomes.
Multiple factors may contribute to the lower long term patency rates of endoscopically harvested grafts. Summarized, the two major contributing factors are theorized to be harvesting techniques and vein trauma during harvesting.
With recognized disadvantages of open vessel harvesting including higher incidence of infection, longer incisions, greater potential for poor healing, and longer length of hospital stay, reducing the failure rate of vein grafts harvested endoscopically is of utmost importance.
It is our hypothesis that modification of existing harvesting techniques can improve vein graft patency in endoscopic vein graft harvesting so that patency rates comparable to open vessel harvesting can be obtained.
In this prospective, multi-center non-randomized, observational study, 100 patients will undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone coronary artery bypass graft (CABG) procedures with endoscopic vein graft harvesting using best harvesting practices. As a part of routine postoperative care, patients will be prescribed dual-antiplatelet therapy of aspirin and clopidogrel. Compliance with 3 months of dual-antiplatelet therapy will be monitored.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males and females at least 18 years of age and able to sign consent
- •Undergoing CABG surgery
- •Eligible for endoscopic saphenous vein harvesting
- •A minimum of two non-sequential vein grafts will be performed
- •Subject willing to comply with the requirements of the protocol
排除标准
- •Previous CABG
- •Previous or concomitant valve surgery
- •Any other concomitant cardiac procedure other than surgical ablation or incidental PFO repair
- •Intolerance to Iodine or IV contrast that cannot be controlled with pre-medication
- •Renal insufficiency with GFR measurement ≤ 40, unless dialysis dependent
- •Abnormal platelet level defined as Plt Count >400,000
- •Abnormal platelet function (hypercoagulable state) as evidenced by TEG testing
- •Allergy to or presence of a condition that the investigator feels may prevent safe administration of ASA or Plavix post-operatively.
- •Patient has a co-morbid condition that in the opinion of the investigator poses undue risk for successful endovascular harvesting of the vein
结局指标
主要结局
Improved vein graft patency
时间窗: Baseline and 12 months
To demonstrate improved vein graft patency at 12 months for endoscopically harvested saphenous vein grafts by using modifications to existing vein harvest techniques in vein handling during harvest.
次要结局
- Vein graft failure(Baseline, 30 days, and 12 months)