Cardiac Computed Tomography Based 3-D Printing for Optimized Coronary Artery Bypass Graft Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Graft failure
研究概览
简要总结
Coronary artery bypass graft surgery (CABG) is a preferred surgical treatment in patients with widespread coronary artery disease. However, studies have shown that up to one third of patients will have closure of at least one bypass graft (graft failure) after one year, which has prognostic implications. Since graft failure can partly be due to inappropriate placement of the distal graft anastomosis, there is a need to develop new surgical methods to ensure optimal placement of the grafts. Three-dimensional (3D) printing is a technique developed to transform digital objects into physical models. The method is widely used in orthopedic surgery and maxillofacial surgery, but has also gained interests in cardiology, and has proved usefull in the preparation for invasive interventions or surgery in patients with complicated anatomy, including congenital heart disease.
The purpose of the study is to investigate, if a surgical strategy, based on a preoperative cardiac CT, including a patient-specific printed 3-D model of the coronary vessels, marked with optimal bypass graft insertion points, can reduce graft failure, assessed by a control cardiac CT examination performed 12 months after surgery. The hypothesis is that 3-D printing of coronary vessels determined from invasive coronary angiography and cardiac CT prior to CABG reduces graft failure 12 months after surgery.
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
- Single (Outcomes Assessor)
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
- •Indication for CABG (with or without valve-surgery), determined by heart team conference. The revascularization plan must include further grafting in addition LIMA to LAD.
排除标准
- •Age <18 years
- •Permanent atrial fibrillation
- •Renal failure (eGRF < 30)
- •Known allergy to contrast material
- •Pregnant and/or breastfeeding
- •Indication for acute CABG
- •Patients who cannot tolerate premedication with nitroglycerin and beta blocker (including LVEF<40%). This applies only to the pre-operative CT scan.
结局指标
主要结局
Graft failure
时间窗: From surgery to the control cardiac CT performed at 12 months
Difference in the proportion of grafts with graft failure 12 months after surgery. Graft failure is defined as: 1) graft occlusion 2) graft stenosis \>50% 3) Graft anastomosis is placed on wrong vessels or proximal to the stenosis 4) String sign (radialis grafts)
次要结局
- Graft failure at a patient level(From surgery to the control cardiac CT performed at 12 months)
- Occluded grafts(From surgery to the control cardiac CT at 12 months)
- Graft stenosis(From surgery to the control cardiac CT at 12 months)
- Grafts placed on wrong vessels or proximal to coronary stenosis(From surgery to the control cardiac CT at 12 months)
- Acute myocardial infarction or new revascularization(From surgery to the control cardiac CT at 12 months)
- Hospitalization for chest pain, acute coronary disease, heart failure or death(From surgery to the control cardiac CT at 12 months)
研究者
Jesper James Linde
Consulting Cardiologist, Associate Professor, Head of Cardiac Imaging Unit at the Department of Cardiology
Rigshospitalet, Denmark