NCT00355563

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Cardica, Inc · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	PAS-Port Automated Proximal Anastomosis System

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-12-01
• Completion: 2008-04-01
• First posted: 2006-07-24
• Last updated: 2009-01-09

Locations

1 site across 1 country: United States