Saphenous Vein Allografts for Coronary Bypass

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Occlusion of Artery Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lenox Hill Hospital

New York, 10075, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Graft Patency

Time frame: 1 to 3 years as defined by the date of their incident operation (CABG surgery).

Secondary outcomes

Morbidity

Time frame: 1 to 3 years defined by the date of their incident operation (CABG surgery)

Sponsors and collaborators

Lead sponsor

CryoLife, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jun 30, 2011
Registry last updated: Dec 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed