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Saphenous Vein Allografts for Coronary Bypass

Completed
Conditions
Coronary Artery Disease
Occlusion 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
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Graft Patency1 to 3 years as defined by the date of their incident operation (CABG surgery).
Secondary Outcome Measures
NameTimeMethod
Morbidity1 to 3 years defined by the date of their incident operation (CABG surgery)

Trial Locations

Locations (1)

Lenox Hill Hospital

🇺🇸

New York, New York, United States

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