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Saphenous Vein Allografts for Coronary Bypass

Sponsor
CryoLife, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01386021
Collaborator
(none)
1
Enrollment
1
Location
5
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Official Title:
    Single Center Evaluation of CryoVein Saphenous Vein Allografts for Coronary Artery Bypass Grafting
    Study Start Date :
    Jun 1, 2011
    Actual Primary Completion Date :
    Oct 1, 2011
    Actual Study Completion Date :
    Nov 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Prior recipients of allografts for CABG

    Outcome Measures

    Primary Outcome Measures

    1. Graft Patency [1 to 3 years as defined by the date of their incident operation (CABG surgery).]

    Secondary Outcome Measures

    1. Morbidity [1 to 3 years defined by the date of their incident operation (CABG surgery)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lenox Hill Hospital New York New York United States 10075

    Sponsors and Collaborators

    • CryoLife, Inc.

    Investigators

    • Principal Investigator: Valavanur A Subramanian, M.D.,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CryoLife, Inc.
    ClinicalTrials.gov Identifier:
    NCT01386021
    Other Study ID Numbers:
    • AVG1101.001-M
    First Posted:
    Jun 30, 2011
    Last Update Posted:
    Dec 21, 2011
    Last Verified:
    Dec 1, 2011
    Keywords provided by CryoLife, Inc.
    allograft
    coronary
    patency
    morbidity
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Dec 21, 2011