Saphenous Vein Allografts for Coronary Bypass
- Conditions
- Coronary Artery DiseaseOcclusion of Artery
- Registration Number
- NCT01386021
- Lead Sponsor
- CryoLife, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
- Any patient implanted with a CryoVein saphenous vein allograft for CABG during 2008 - 2010 time frame.
- Patients > 18 years of age at implant.
• Patients < 18 years of age.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Graft Patency 1 to 3 years as defined by the date of their incident operation (CABG surgery).
- Secondary Outcome Measures
Name Time Method Morbidity 1 to 3 years defined by the date of their incident operation (CABG surgery)
Related Research Topics
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Trial Locations
- Locations (1)
Lenox Hill Hospital
🇺🇸New York, New York, United States