Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
- Conditions
- Heart Disease
- Interventions
- Device: Anastomosis (C-Port® )
- Registration Number
- NCT01478061
- Lead Sponsor
- Cardica, Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description anastomoses in blood vessels and grafts Anastomosis (C-Port® ) -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (7)
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Cardiopulmonary Research Science & Technology Institute
🇺🇸Dallas, Texas, United States
Wisconsin Heart
🇺🇸Wauwatosa, Wisconsin, United States
University of Arkansas
🇺🇸Little Rock, Arkansas, United States
Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Methodist Hospital - Houston
🇺🇸Houston, Texas, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States