Saphenous Vein Allografts for Coronary Bypass
Single Center Evaluation of CryoVein Saphenous Vein Allografts for Coronary Artery Bypass Grafting
1 other identifier
observational
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 29, 2011
CompletedFirst Posted
Study publicly available on registry
June 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedDecember 21, 2011
December 1, 2011
4 months
June 29, 2011
December 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Graft Patency
1 to 3 years as defined by the date of their incident operation (CABG surgery).
Secondary Outcomes (1)
Morbidity
1 to 3 years defined by the date of their incident operation (CABG surgery)
Study Arms (1)
Prior recipients of allografts for CABG
Eligibility Criteria
Patients having a previous implant of CryoVein Saphenous Vein allografts for CABG between 2008 - 2010, at a single instituion
You may qualify if:
- Any patient implanted with a CryoVein saphenous vein allograft for CABG during 2008 - 2010 time frame.
- Patients \> 18 years of age at implant.
You may not qualify if:
- Patients \< 18 years of age.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CryoLife, Inc.lead
Study Sites (1)
Lenox Hill Hospital
New York, New York, 10075, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valavanur A Subramanian, M.D.
Study Design
- Study Type
- observational
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2011
First Posted
June 30, 2011
Study Start
June 1, 2011
Primary Completion
October 1, 2011
Study Completion
November 1, 2011
Last Updated
December 21, 2011
Record last verified: 2011-12