About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age <18 years
Permanent atrial fibrillation
Renal failure (eGRF < 30)
Known allergy to contrast material
Trial design
Parallel
Treatments tested in this trial
3D print of coronary arteries
Diagnostic testBased on a pre-surgical cardiac CT the optimal graft insertions points on the target coronary arteries wil be marked and a patient-specific model of the coronary arteries will be 3D-printed and sterialized to be available during CABG to guide the placement of the distal graft anastomosis.
Treatment groups
Trial outcomes
Primary outcomes
Graft failure
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)
Secondary outcomes
Graft failure at a patient level
Difference in the proportion of patients with graft failure at 12 months
Occluded grafts
Difference in number of occluded grafts at 12 months (graft level and patient level)
Graft stenosis
Difference in proportion of graft stenosis at 12 months (graft level and patient level)
Grafts placed on wrong vessels or proximal to coronary stenosis
Difference in the number of grafts placed on wrong vessels or proximal to coronary stenosis (graft level and patient level)
Other outcomes
Myocardial perfusion
Difference in myocardial perfusion assessed by cardiac CT scan at 12 months.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jesper James Linde
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Rigshospitalet, Denmark
Collaborator
This trial is not recruiting at the moment. You can still explore other options: