Cardica C – Port xA ™ Anastomotic System

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21446

Enrollment

Registered

2008-08-17

Start date

2008-08-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

angina pectoris, coronary disease, CABG, Sutureless anastomoses, vascular connector

Interventions

Coronary Bypass Surgery

Eligibility

Inclusion criteria

Inclusion criteria: 1. Abe to give informed consent able to understand the intent and clinical meaning of the study as well as its implication. 2. Patients 18 years old or older. 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. Not a standard CABG operation or is 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. Congestive heart failure or been classified NYHA Class IV in the last 30 days. 9. History of bleeding disorder or history of thromboembolic disease requiring anticoagulation therapy. 10. Hemodynamically unstable. 11. History of acute or chronic dialysis. 12. Creatinine level of > 200 mmol/ml or 2,3 mg/dL in the last 30 days. 13. Documented or suspected acute systemic infection. 14. Need for immunosuppressive therapy. 15. Cerebrovascular accident within the last 2 weeks. 16. Allergy or other contraindication for aspirin or other anticoagulant/antiplatelet therapy

Design outcomes

Primary

Measure	Time frame
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	—

Contacts

Public ContactBerreklouw

Catharina Hospital Dep. Cardiothoracic Surgery, research and development

+31 (0)40 2398680

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)