Status:
COMPLETED
Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
Lead Sponsor:
Cardica, Inc
Conditions:
Heart Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The Study plan is a post-market prospective, multi-center, open-label registry. The vein graft failure rates for the currently commercialized C-Port devices will be compared to an a priori rate taken ...
Detailed Description
To satisfy the requirements set forth in post-market surveillance orders issued by the US FDA to Cardica, Inc., the following outcomes will be evaluated: 1. Acute, midterm, and one-year graft failure...
Eligibility Criteria
Inclusion
- Able to give informed consent.
- Willing and able to have follow-up visits and examinations.
- Less than 80 years old.
- Have an ejection fraction of \>30 %.
- Have a life expectancy of \>1 year.
- Pre-Operative
Exclusion
- Currently participating in other clinical trials that would conflict with this protocol.
- Unable to meet study requirements.
- Currently pregnant.
- Require preoperative use of an intraaortic balloon pump.
- Have a history of a bleeding disorder or history of a thromboembolic disease requiring anticoagulation therapy.
- Have congestive heart failure or been classified as NYHA Class IV.
- Have an aspirin allergy or other contraindications to aspirin use.
- Previous coronary artery bypass surgery.
- Vasculitis or other nonatherosclerotic cause for coronary artery disease.
- Intra-Operative
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01478061
Start Date
April 1 2009
End Date
July 1 2015
Last Update
July 22 2015
Active Locations (7)
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1
University of Arkansas
Little Rock, Arkansas, United States, 72205
2
Genesis Medical Center
Davenport, Iowa, United States, 52803
3
Lenox Hill Hospital
New York, New York, United States, 10075
4
Akron General Medical Center
Akron, Ohio, United States, 44307