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Saphenous Vein Allografts for Coronary Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CryoLife, Inc.
ClinicalTrials.gov Identifier:
NCT01386021
First received: June 29, 2011
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Coronary Artery Disease
Occlusion of Artery

Study Type: Observational
Official Title: Single Center Evaluation of CryoVein Saphenous Vein Allografts for Coronary Artery Bypass Grafting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CryoLife, Inc.:

Primary Outcome Measures:
  • Graft Patency [ Time Frame: 1 to 3 years as defined by the date of their incident operation (CABG surgery). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity [ Time Frame: 1 to 3 years defined by the date of their incident operation (CABG surgery) ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Prior recipients of allografts for CABG

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: CryoLife, Inc.
ClinicalTrials.gov Identifier: NCT01386021     History of Changes
Other Study ID Numbers: AVG1101.001-M
Study First Received: June 29, 2011
Last Updated: December 20, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013