NCT07039838

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Jesper James Linde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-06-26
• Last updated: 2025-07-08

Locations

1 site across 1 country: Denmark