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Study of the PAS-Port® Proximal Anastomosis System in Coronary Bypass Surgery — EPIC  

Coronary Artery Disease Clinical Trial

Official title:
Use of the PAS-Port Proximal Anastomosis System for Creation of Aorto-Venous Proximal Anastomoses in Coronary Bypass Surgery

Clinical Trial Summary

The study has been designed to comparatively evaluate the safety and effectiveness of the PAS-Port Proximal Anastomosis System and conventional suturing techniques for creation of the connection between graft veins and the aorta in patients undergoing coronary artery bypass graft surgery for treatment of coronary artery disease. Patients in the study will have a coronary angiogram approximately 9 months following surgery to determine the patency of vein grafts created using either the automated PAS-Port or hand sewn methods. Safety will be evaluated by documenting the occurence of adverse clinical events and evealuating possible association with either method.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00355563
Study type Interventional
Source Cardica, Inc
Contact
Status Completed
Phase Phase 3
Start date June 2006
Completion date April 2008
View Details
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