Saphenous Vein Allografts for Coronary Bypass

This study has been completed.
Information provided by (Responsible Party):
CryoLife, Inc. Identifier:
First received: June 29, 2011
Last updated: December 20, 2011
Last verified: December 2011
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.

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:

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)
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01386021

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

No publications provided

Responsible Party: CryoLife, Inc. 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.:

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases processed this record on November 30, 2015