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

NCT07039838 | Not Yet Recruiting

• 1 other identifier: H-24070405
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Arterial Disease (CAD); Bypass Graft Occlusion

Outcome Measures

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)

  From surgery to the control cardiac CT performed at 12 months

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• Myocardial perfusion

  From surgery to the control Cardiac CT performed at 12 months

Study Arms (2)

Control

NO INTERVENTION

Will undergo CABG as per usual clinical practice

3D-print guided CABG

EXPERIMENTAL

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

Interventions

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.

3D-print guided CABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jesper James Linde: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Central Study Contacts

Jesper J Linde, MD, PhD

CONTACT

+4535456396; jesper.james.linde@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consulting Cardiologist, Associate Professor, Head of Cardiac Imaging Unit at the Department of Cardiology

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)