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NCT Number: NCT07039838

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Location contact

Jesper J Linde, MD, PhD

CONTACT

[email protected]

(+45) 35456396

Sulman Rafiq, MD, PhD

CONTACT

[email protected]

(+45) 35451174

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Graft failure

    Time frame: 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)

Secondary outcomes

  1. Graft failure at a patient level

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

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

  2. Occluded grafts

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

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

  3. Graft stenosis

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

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

  4. Grafts placed on wrong vessels or proximal to coronary stenosis

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

    Difference in the number of grafts placed on wrong vessels or proximal to coronary stenosis (graft level and patient level)

  5. Acute myocardial infarction or new revascularization

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

    Acute myocardial infarction or renewed revascularization at 12 months.

  6. Hospitalization for chest pain, acute coronary disease, heart failure or death

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

    Hospitalization with chest pain, acute coronary disease, heart failure or death at 12 months

Other outcomes

  1. Myocardial perfusion

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jesper J Linde, MD, PhD

CONTACT

[email protected]

+4535456396

Sponsors and collaborators

Lead sponsor

Jesper James Linde

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Acronym: 3DCABG

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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