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Saphenous Vein Allografts for Coronary Bypass

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ClinicalTrials.gov Identifier: NCT01386021
Recruitment Status : Completed
First Posted : June 30, 2011
Last Update Posted : December 21, 2011
Sponsor:
Information provided by (Responsible Party):

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
Coronary Artery Disease Occlusion of Artery

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 : June 2011
Primary Completion Date : October 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Prior recipients of allografts for CABG


Outcome Measures

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

Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 1 to 3 years defined by the date of their incident operation (CABG surgery) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386021


Locations
United States, New York
Lenox Hill Hospital
New York, New York, United States, 10075
Sponsors and Collaborators
CryoLife, Inc.
Investigators
Principal Investigator: Valavanur A Subramanian, M.D.
More Information

Responsible Party: CryoLife, Inc.
ClinicalTrials.gov Identifier: NCT01386021     History of Changes
Other Study ID Numbers: AVG1101.001-M
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: December 21, 2011
Last Verified: December 2011

Keywords provided by CryoLife, Inc.:
allograft
coronary
patency
morbidity

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases