Status:
TERMINATED
Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II
Lead Sponsor:
Cardica, Inc
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
This evaluation is designed to evaluate the feasibility of using an automated distal coronary anastomotic to facilitate grafting of the left internal mammary artery to the left anterio descending coro...
Detailed Description
Evaluation of automated distal anastomotic device as a surrogate for hand-sewn grafts for completion of arterial conduit anastomosis between the Left Internal Mammary Artery and Left Anterior Descendi...
Eligibility Criteria
Inclusion
- Age between 50 and 85 years (inclusive)
- Diagnostically confirmed coronary disease
- Ejection fraction \> 30%
- Tolerate contrast media
- Acceptable LIMA (conduit) and LAD (target)for grafting
- Life expectancy \> 1 year
Exclusion
- Refusal to give informed consent
- Unable to meet study travel and general health requirements
- Pregnancy
- Previous cardiac surgery
- NYHA Class IV
- Preoperative need for IABP
- Acute or chronic dialysis (creatinine \> 200mmolor 2.3 mg/dL) within 30 days of surgery
- Acute or suspected systemic infection
- Need for ongoing immunosuppressive therapy
- Recent history (\<2 weeks) of CVA
- Aspirin allergy
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00292500
Start Date
January 1 2006
End Date
December 1 2009
Last Update
August 21 2013
Active Locations (1)
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1
Klinik für Herzchirurgie
Leipzig, Germany, D-04289