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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bypass Graft Occlusion; Coronary Arterial Disease (CAD)
• Intervention / Treatment: Diagnostic test: 3D print of coronary arteries

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesper J Linde, MD, PhD; Phone Number: +4535456396; Email: jesper.james.linde@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
    • Contact: Jesper J Linde, MD, PhD; Phone Number: (+45) 35456396; Email: jesper.james.linde@regionh.dk
    • Contact: Sulman Rafiq, MD, PhD; Phone Number: (+45) 35451174; Email: sulman.rafiq@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Will undergo CABG as per usual clinical practice
Experimental: 3D-print guided CABG; Will have a CT-based 3D-print of the coronary arteries marked with the optimal graft insertion points to be used during CABG	Diagnostic test: 3D print of coronary arteries; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From surgery to the control cardiac CT performed at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft failure at a patient level	Difference in the proportion of patients with graft failure at 12 months	From surgery to the control cardiac CT performed at 12 months
Occluded grafts	Difference in number of occluded grafts at 12 months (graft level and patient level)	From surgery to the control cardiac CT at 12 months
Graft stenosis	Difference in proportion of graft stenosis at 12 months (graft level and patient level)	From surgery to the control cardiac CT at 12 months
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)	From surgery to the control cardiac CT at 12 months
Acute myocardial infarction or new revascularization	Acute myocardial infarction or renewed revascularization at 12 months.	From surgery to the control cardiac CT at 12 months
Hospitalization for chest pain, acute coronary disease, heart failure or death	Hospitalization with chest pain, acute coronary disease, heart failure or death at 12 months	From surgery to the control cardiac CT at 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial perfusion	Difference in myocardial perfusion assessed by cardiac CT scan at 12 months.	From surgery to the control Cardiac CT performed at 12 months

Collaborators and Investigators

• Sponsor: Jesper James Linde
• Collaborators: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: June 18, 2025
• First Submitted That Met QC Criteria: June 18, 2025
• First Posted (Actual): June 26, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: H-24070405 (Other Identifier: The Committees on Health Research Ethics in the Capital Region of Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not have approval to share patient data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No