Saphenous Vein Allografts for Coronary Bypass

December 20, 2011 updated by: CryoLife, Inc.

Single Center Evaluation of CryoVein Saphenous Vein Allografts for Coronary Artery Bypass Grafting

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10075
        • Lenox Hill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients having a previous implant of CryoVein Saphenous Vein allografts for CABG between 2008 - 2010, at a single instituion

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Prior recipients of allografts for CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Graft Patency
Time Frame: 1 to 3 years as defined by the date of their incident operation (CABG surgery).
1 to 3 years as defined by the date of their incident operation (CABG surgery).

Secondary Outcome Measures

Outcome Measure
Time Frame
Morbidity
Time Frame: 1 to 3 years defined by the date of their incident operation (CABG surgery)
1 to 3 years defined by the date of their incident operation (CABG surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CryoLife, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

June 29, 2011

First Submitted That Met QC Criteria

June 29, 2011

First Posted (Estimate)

June 30, 2011

Study Record Updates

Last Update Posted (Estimate)

December 21, 2011

Last Update Submitted That Met QC Criteria

December 20, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVG1101.001-M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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