NCT01478061

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Cardica, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Disease

Interventions

Type	Name	Description
DEVICE	Anastomosis (C-Port® )	creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures

Timeline

• Start date: 2009-04-01
• Primary completion: 2013-01-01
• Completion: 2015-07-01
• First posted: 2011-11-23
• Last updated: 2015-07-22

Locations

7 sites across 1 country: United States