Cardica C - Port xA * Anastomotic System

Phase 4

Completed

Conditions: coronary artery bypass operation
10007593

Registration Number: NL-OMON31599

Lead Sponsor: ST Europe bv.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 78

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 < 2

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy<br /><br>a. Acute: The presence of acute patency of the distal anastomoses as determined<br /><br>by flow measurements intraoperatively.<br /><br>b. Chronic: The presence of patency of the distal anastomoses as determined by<br /><br>multislice CT - Scan at 12 months.<br /><br>c. Incidence of device related Adverse Events</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>a. Time required for system loading and for the distal anastomosis to be<br /><br>completed.<br /><br>b. User friendliness of the system<br /><br>c. Abbreviated ischemic time using Cardica * C - Port xA</p><br>