coronary artery bypass operation
Conditions
Interventions
End-to-end anastomoses of the radial-LITA anastomoses with the GEM flow
Microvascular coupler
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: a. Able to give informed consent able to understand the intent and clinical meaning of the study as well as its implication. b. Patients between 18 years and 70 years old c. Willing and able to have follow-up visits and examinations d. Standard Euroscore
Exclusion criteria
Exclusion criteria: a. Procedure is done as an emergency operation b. Unable to meet study requirements, i.e. mobility challenge c. Participation in any other clinical trial d. Pregnancy e. Concomitant with heart valve surgery f. History of any cardiac surgery other than PTCA and stent placement g. History of IABP within the last 30 days h. History of atrial fibrillation i. Congestive heart failure or been classified NYHA Class IV in the last 30 days j. History of bleeding disorder or history of thromboembolic disease requiring anticoagulation therapy k. Hemodynamically unstable l. History of acute or chronic dialysis m. Creatinine level of > 200 mmol/ml or 2,3 mg/dL in the last 30 days n. Documented or suspected acute systemic infection o. Need for immunosuppressive therapy p. Cerebrovascular accident within the last 2 weeks q. Allergy or other contraindication for aspirin or other anticoagulant/antiplatelet therapy r. Allergy or other contraindication for Iomeron® contrast agent s. Allergy or other contraindication for metoprolol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints Efficacy a. Acute Patency: The presence of acute patency of the end-to-end radial-lita anastomoses as determined by flow measurements intraoperatively. b. Chronic Patency: The presence of patency of the end-to-end radial-lita anastomoses as determined by multislice CT - Scan at 3 months. c. Incidence of device related Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| x | — |
Countries
Netherlands
Outcome results
None listed