PATENCY OF THE;GEM MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM* ;IN CORONARY ARTERY BYPASS GRAFTING;Pilot Study
- Conditions
- coronary artery bypass operation10011082
- Registration Number
- NL-OMON38998
- Lead Sponsor
- Catharina-ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
a. Able to give informed consent able to understand the intent and clinical meaning of the study as well as its implication.
b. Patients between 18 years and 70 years old
c. Willing and able to have follow-up visits and examinations
d. Standard Euroscore < 2
a. Procedure is done as an emergency operation
b. Unable to meet study requirements, i.e. mobility challenge
c. Participation in any other clinical trial
d. Pregnancy
e. Concomitant with heart valve surgery
f. History of any cardiac surgery other than PTCA and stent placement
g. History of IABP within the last 30 days
h. History of atrial fibrillation
i. Congestive heart failure or been classified NYHA Class IV in the last 30 days
j. History of bleeding disorder or history of thromboembolic disease requiring anticoagulation therapy
k. Hemodynamically unstable
l. History of acute or chronic dialysis
m. Creatinine level of > 200 mmol/ml or 2,3 mg/dL in the last 30 days
n. Documented or suspected acute systemic infection
o. Need for immunosuppressive therapy
p. Cerebrovascular accident within the last 2 weeks
q. Allergy or other contraindication for aspirin or other anticoagulant/antiplatelet therapy
r. Allergy or other contraindication for Iomeron® contrast agent
s. Allergy or other contraindication for metoprolol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoints<br /><br>Efficacy<br /><br>a. Acute Patency: The presence of acute patency of the end-to-end radial-lita<br /><br>anastomoses as determined by flow measurements intraoperatively.<br /><br>b. Chronic Patency: The presence of patency of the end-to-end radial-lita<br /><br>anastomoses as determined by multislice CT - Scan at 3 months.<br /><br>c. Incidence of device related Adverse Events</p><br>
- Secondary Outcome Measures
Name Time Method <p>x</p><br>