Saphenous Vein Allografts for Coronary Bypass

NCT ID: NCT01386021

Last Updated: 2011-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Occlusion of Artery

Keywords

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allograft coronary patency morbidity

Study Groups

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Prior recipients of allografts for CABG

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CryoLife, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valavanur A Subramanian, M.D.

Role: PRINCIPAL_INVESTIGATOR

Locations

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Lenox Hill Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AVG1101.001-M

Identifier Type: -

Identifier Source: org_study_id