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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device|
- Graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses. [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Technical Failure Rates [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Technical failure rates when completing an anastomosis using the C-Port products.
- Technical success rate of hand-sewn [ Time Frame: Day 1 and 12 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||January 2014|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: anastomoses in blood vessels and grafts||
Device: Anastomosis (C-Port® )
creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478061
|United States, Arkansas|
|University of Arkansas|
|Little Rock, Arkansas, United States, 72205|
|United States, Iowa|
|Genesis Medical Center|
|Davenport, Iowa, United States, 52803|
|United States, New York|
|Lenox Hill Hospital|
|New York, New York, United States, 10075|
|United States, Ohio|
|Akron General Medical Center|
|Akron, Ohio, United States, 44307|
|United States, Texas|
|Cardiopulmonary Research Science & Technology Institute|
|Dallas, Texas, United States, 75230|
|Methodist Hospital - Houston|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|Wauwatosa, Wisconsin, United States, 53226|
|Principal Investigator:||Husam Balkhy, MD||Wisconsin Heart Hospital|