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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. Technical failure rates when attempting to complete an anastomosis using the C-Port xA, FlexA, and XCHANGE Distal Anastomosis Systems. 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.

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

Conditions
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Heart Disease

Intervention / Treatment
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* Device: Anastomosis (C-Port® )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: anastomoses in blood vessels and grafts<br> | Device: Anastomosis (C-Port® )<br>* creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures<br>* Other names: C-Port® XCHANGE™ Distal Anastomosis System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses. | a. Acute, midterm, and one-year graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Failure Rates | Technical failure rates when completing an anastomosis using the C-Port products. | Day 1 | 
| Technical success rate of hand-sewn | The technical success rate of hand-sewn anastomoses following technical failures of the C-Port products and the hand-sewn graft patency rates and clinical sequelae at one year. | Day 1 and 12 months |