Heart Disease Clinical Trial
Official title:
Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
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 from the peer-reviewed literature.
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 rates for coronary revascularization using
the C-Port® xA™ Distal Anastomosis System, C-Port® FlexA™ Distal Anastomosis System,
and C-Port® XCHANGE™ Distal Anastomosis System when in general use in the United States
compared to hand-sewn anastomoses.
2. Technical failure rates when attempting to complete an anastomosis using the C-Port xA,
FlexA, and XCHANGE Distal Anastomosis Systems.
3. The technical success rate of hand-sewn anastomoses following technical failures of the
C-Port devices and the hand-sewn graft patency rates and clinical sequelae at one year.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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