Coronary Artery Disease, Occlusion of Artery
Conditions
Keywords
allograft, coronary, patency, morbidity
Brief 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.
Interventions
None listed
Sponsors
CryoLife, Inc.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient implanted with a CryoVein saphenous vein allograft for CABG during 2008 - 2010 time frame. * Patients \> 18 years of age at implant.
Exclusion criteria
• Patients \< 18 years of age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft Patency | 1 to 3 years as defined by the date of their incident operation (CABG surgery). |
Secondary
| Measure | Time frame |
|---|---|
| Morbidity | 1 to 3 years defined by the date of their incident operation (CABG surgery) |
Countries
United States
Outcome results
None listed