NCT01386021

Saphenous Vein Allografts for Coronary Bypass

Single Center Evaluation of CryoVein Saphenous Vein Allografts for Coronary Artery Bypass Grafting

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: CryoLife, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this observational study is to evaluate the function (patency) of cryopreserved saphenous vein allografts used as coronary artery bypass grafts (CABG) for patients with occlusive coronary artery disease.

Detailed description

This Study is designed as a combination retrospective/prospective single center study in which all patients will be eligible for enrollment based on having a previous implant of CryoVein Saphenous Vein for CABG during the 2008-2010 time frame. A comprehensive chart review of former and previously implanted allograft patients will be performed for the retrospective portion of this Study. An effort will be made to include all patients from this site. Eligible patients will be consented into the Study for a single, prospective, observational imaging evaluation of their bypass conduits.

Conditions

• Coronary Artery Disease
• Occlusion of Artery

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-10-01
• Completion: 2011-11-01
• First posted: 2011-06-30
• Last updated: 2011-12-21

Locations

1 site across 1 country: United States