Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device

Completed · Phase 4

Conditions studied: Heart Disease

In brief

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.

Key facts

Study ID

NCT01478061

Run by

Cardica, Inc

People needed

115

Starts

2009-04-01

Expected to finish

2015-07-01

Last updated by the study team

2015-07-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Criteria:
• 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 Exclusion Criteria:
• At least one target vessel site where the C-Port anastomosis will be placed that is free from severe calcification or severe atheromas
• Target vessel wall properties where the C-Port anastomosis will be placed are suitable for hand-sewn anastomosis
• Target vessel diameter is ≥ 1.3 mm
• Target vessel has a single wall thickness ≤ 0.75mm
• Hemodynamically stable

Where it is running

• University of Arkansas — Little Rock, Arkansas, United States
• Genesis Medical Center — Davenport, Iowa, United States
• Lenox Hill Hospital — New York, New York, United States
• Akron General Medical Center — Akron, Ohio, United States
• Cardiopulmonary Research Science & Technology Institute — Dallas, Texas, United States
• Methodist Hospital - Houston — Houston, Texas, United States
• Wisconsin Heart — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

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