cabg, total arterial revascularization
Conditions
Interventions
Standard CABG procedure, with extended radial artery technique, with the radial-lita anastomoses facilitated with the GEM flow microvascular coupler.
Sponsors
Catharina Hospital Eindhoven.
Sponsor: none
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able to give informed consent able to understand the intent and clinical meaning of the study as well as its implication; 2. Patients between 18 years and 70 years old; 3. Willing and able to have follow-up visits and examinations; 4. Standard Euroscore < 2.
Exclusion criteria
Exclusion criteria: 1. Procedure is done as an emergency operation; 2. Unable to meet study requirements, i.e. mobility challenge; 3. Participation in any other clinical trial; 4. Pregnancy; 5. Concomitant with heart valve surgery; 6. History of any cardiac surgery other than PTCA and stent placement; 7. History of IABP within the last 30 days; 8. History of atrial fibrillation; 9. Congestive heart failure or been classified NYHA Class IV in the last 30 days; 10. History of bleeding disorder or history of thromboembolic disease requiring anticoagulation therapy; 11. Hemodynamically unstable; 12. History of acute or chronic dialysis; 13. Creatinine level of > 200 mmol/ml or 2,3 mg/dL in the last 30 days; 14. Documented or suspected acute systemic infection; 15. Need for immunosuppressive therapy; 16. Cerebrovascular accident within the last 2 weeks; 17. Allergy or other contraindication for aspirin or other anticoagulant/antiplatelet therapy; 18. Allergy or other contraindication for Iomeron® contrast agent; 19. Allergy or other contraindication for metoprolol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Acute Patency: The presence of acute patency of the distal anastomoses as determined by flow measurements intraoperatively; 2. Chronic Patency: The presence of patency of the end-to-end radial-lita anastomoses as determined by multislice CT - Scan at 3 months; 3. Incidence of device related Adverse Events. | — |
Contacts
Public ContactN.J. Verberkmoes
Michelangelolaan 2
Outcome results
None listed