Heart Disease
Conditions
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 from the peer-reviewed literature.
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 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.
Interventions
DEVICEAnastomosis (C-Port® )
creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures
Sponsors
Cardica, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses. | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Failure Rates | Day 1 | Technical failure rates when completing an anastomosis using the C-Port products. |
| Technical success rate of hand-sewn | Day 1 and 12 months | 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. |
Countries
United States
Outcome results
None listed