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

Обзор

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Graft failure [Срок оценки: From surgery to the control cardiac CT performed at 12 months]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Rigshospitalet — Copenhagen

Идентификаторы

NCT: NCT07039838 · H-24070405 · H-24070405

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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