Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01478061|
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : July 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Heart Disease||Device: Anastomosis (C-Port® )||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||July 2015|
|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
- Graft patency rates for coronary revascularization when in general use in the United States compared to hand-sewn anastomoses. [ Time Frame: 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.
- Technical Failure Rates [ Time Frame: Day 1 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|