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

NCT ID: NCT07039838

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Will undergo CABG as per usual clinical practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

3D print of coronary arteries

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Jesper James Linde

OTHER

Sponsor Role: lead

Responsible Party

Jesper James Linde

Consulting Cardiologist, Associate Professor, Head of Cardiac Imaging Unit at the Department of Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Central Contacts

Jesper J Linde, MD, PhD

Role: CONTACT

jesper.james.linde@regionh.dk

+4535456396

Facility Contacts

Jesper J Linde, MD, PhD

Role: primary

jesper.james.linde@regionh.dk

(+45) 35456396

Sulman Rafiq, MD, PhD

Role: backup

sulman.rafiq@regionh.dk

(+45) 35451174

Other Identifiers

H-24070405

Identifier Type: OTHER

Identifier Source: secondary_id

H-24070405

Identifier Type: -

Identifier Source: org_study_id