Back to resultsSaphenous Vein Allografts for Coronary Bypass
Primary Purpose
Coronary Artery Disease, Occlusion of Artery
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Coronary Artery Disease focused on measuring allograft, coronary, patency, morbidity
Eligibility Criteria
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.
Sites / Locations
- Lenox Hill Hospital
Arms of the Study
Arm 1
Arm Type
Arm Label
Prior recipients of allografts for CABG
Arm Description
Outcomes
Primary Outcome Measures
Graft Patency
Secondary Outcome Measures
Morbidity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01386021
Brief Title
Saphenous Vein Allografts for Coronary Bypass
Official Title
Single Center Evaluation of CryoVein Saphenous Vein Allografts for Coronary Artery Bypass Grafting
Study Type
Observational
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CryoLife, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Occlusion of Artery
Keywords
allograft, coronary, patency, morbidity
7. Study Design
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prior recipients of allografts for CABG
Primary Outcome Measure Information:
Title
Graft Patency
Time Frame
1 to 3 years as defined by the date of their incident operation (CABG surgery).
Secondary Outcome Measure Information:
Title
Morbidity
Time Frame
1 to 3 years defined by the date of their incident operation (CABG surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Population Description
Patients having a previous implant of CryoVein Saphenous Vein allografts for CABG between 2008 - 2010, at a single instituion
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valavanur A Subramanian, M.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Saphenous Vein Allografts for Coronary Bypass
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