Cardiac Computed Tomography Based 3-D Printing for Optimized Coronary Artery Bypass Graft Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJesper James Linde

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 3D print of coronary arteries

    Diagnostic test

    Based 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

200 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: 3D-print guided CABGExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
From surgery to the control cardiac CT performed at 12 months

Secondary outcomes

1

Graft failure at a patient level

Difference in the proportion of patients with graft failure at 12 months

Time frame
From surgery to the control cardiac CT performed at 12 months
2

Occluded grafts

Difference in number of occluded grafts at 12 months (graft level and patient level)

Time frame
From surgery to the control cardiac CT at 12 months
3

Graft stenosis

Difference in proportion of graft stenosis at 12 months (graft level and patient level)

Time frame
From surgery to the control cardiac CT at 12 months
4

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)

Time frame
From surgery to the control cardiac CT at 12 months

Other outcomes

1

Myocardial perfusion

Difference in myocardial perfusion assessed by cardiac CT scan at 12 months.

Time frame
From surgery to the control Cardiac CT performed 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

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