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Not yet recruiting NCT07039838

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

No phase Interventional Coronary Arterial Disease (CAD) Bypass Graft Occlusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3D print of coronary arteries.
Who it may be relevant to
Registry conditions: Coronary Arterial Disease (CAD), Bypass Graft Occlusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Graft failure [Time frame: From surgery to the control cardiac CT performed at 12 months]
Secondary outcome measures (6)
  • Graft failure at a patient level [Time frame: From surgery to the control cardiac CT performed at 12 months]
  • Occluded grafts [Time frame: From surgery to the control cardiac CT at 12 months]
  • Graft stenosis [Time frame: From surgery to the control cardiac CT at 12 months]
  • Grafts placed on wrong vessels or proximal to coronary stenosis [Time frame: From surgery to the control cardiac CT at 12 months]
  • Acute myocardial infarction or new revascularization [Time frame: From surgery to the control cardiac CT at 12 months]
  • Hospitalization for chest pain, acute coronary disease, heart failure or death [Time frame: From surgery to the control cardiac CT at 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Rigshospitalet — Copenhagen

Identifiers

NCT: NCT07039838 · H-24070405 · H-24070405

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗