Cardica C – Port xA ™ Anastomotic System
Completed
- Conditions
- angina pectoris, coronary disease, CABG, Sutureless anastomoses, vascular connector
- Registration Number
- NL-OMON21446
- Lead Sponsor
- Dr. BerreklouwDrs. J. ter WoorstDrs. N.J. Verberkmoes
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 78
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.
Exclusion Criteria
1.Procedure is done as an emergency operation.
2.Unable to meet study requirements, i.e. mobility challenge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a.Acute: The presence of acute patency of the distal anastomoses as determined by flow measurements intraoperatively.<br /><br>b.Chronic: The presence of patency of the distal anastomoses as determined by multislice CT - Scan at 12 months. <br /><br>c.Incidence of device related Adverse Events<br>
- Secondary Outcome Measures
Name Time Method a. Time required for system loading and for the distal anastomosis to be completed.<br /><br>b. User friendliness of the system<br /><br>c. Abbreviated ischemic time using Cardica ™ C - Port xA<br>