A 1-year Prospective, Multicenter, Non-Randomized, Observational, Study to Evaluate 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
- 100
- 试验地点
- 2
- 主要终点
- Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques
研究概览
简要总结
This is an observational study of lone Coronary Artery Bypass Grafting procedures with endoscopic vein graft harvesting using best harvesting practices.
详细描述
This is a prospective, multi-center, non-randomized, observational study of 100 patients who will undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone Coronary Artery Bypass Graft (CABG) procedures with endoscopic vein harvesting using best harvesting practices, defined as: systemic heparinization prior to vein manipulation, standardization of vein graft harvesting techniques, pressure limiting syringe and 3 month use of dual anti-platelet therapy. Patients will undergo a CT angiography at 30 days and 12 months to assess vein graft patency.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 and able to provide consent
- •Eligible for endoscopic vein harvesting
- •Minimum of two non sequential vein grafts
- •Willing to comply with requirements of 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
Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques
时间窗: 12 months
To demonstrate improved vein graft patency rates at 12 months for endoscopically harvest saphenous vein grafts by employment of modifications to existing techniques in vein graft handling during harvests. Vein graft patency will be measured at 30 days post CABG and at one year post CABG as evaluated by cardiac CT angiography or cardiac catheterization.
次要结局
- OPTION(12 months)