coronary artery bypass operation
Conditions
Interventions
Facilitating distal anastomoses with mechanical connector device.
Sponsors
LST Europe bv.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Undergoing CABG - Able to give informed consent able to understand the intent and clinical meaning of the study as well as its implication. - Patients 18 years old or older - Willing and able to have follow-up visits and examinations - Standard Euroscore
Exclusion criteria
Exclusion criteria: - Procedure is done as an emergency operation - Unable to meet study requirements, i.e. mobility challenge - Participation in any other clinical trial - Pregnancy - Not a standard CABG operation or is concomitant with heart valve surgery - History of any cardiac surgery other than PTCA and stent placement - History of IABP within the last 30 days - Congestive heart failure or been classified NYHA Class IV in the last 30 days - History of bleeding disorder or history of thromboembolic disease requiring anticoagulation therapy - Hemodynamically unstable - History of acute or chronic dialysis - Creatinine level of > 200 mmol/ml or 2,3 mg/dL in the last 30 days - Documented or suspected acute systemic infection - Need for immunosuppressive therapy - Cerebrovascular accident within the last 2 weeks - Allergy or other contraindication for aspirin or other anticoagulant/antiplatelet therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy a. Acute: The presence of acute patency of the distal anastomoses as determined by flow measurements intraoperatively. b. Chronic: The presence of patency of the distal anastomoses as determined by multislice CT - Scan at 12 months. c. Incidence of device related Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Time required for system loading and for the distal anastomosis to be completed. b. User friendliness of the system c. Abbreviated ischemic time using Cardica * C - Port xA | — |
Countries
Netherlands
Outcome results
None listed