Rigshospitalet
Copenhagen, 2100, Denmark
Location contact
Jesper J Linde, MD, PhD
CONTACT
(+45) 35456396
Sulman Rafiq, MD, PhD
CONTACT
(+45) 35451174
NCT Number: NCT07039838
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Copenhagen, 2100, Denmark
Jesper J Linde, MD, PhD
CONTACT
(+45) 35456396
Sulman Rafiq, MD, PhD
CONTACT
(+45) 35451174
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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)
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
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)
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)
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)
Time frame: From surgery to the control cardiac CT at 12 months
Acute myocardial infarction or renewed revascularization at 12 months.
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
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.
Contact information is provided by the study sponsor or research team.
Jesper James Linde
Other
Acronym: 3DCABG
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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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