Saphenous Vein Allografts for Coronary Bypass

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386021
• Other study ID #: AVG1101.001-M
• Status: Completed
• Phase: N/A
• First received: June 29, 2011
• Last updated: December 20, 2011
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: CryoLife, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Occlusion of Artery

Locations

Country	Name	City	State
United States	Lenox Hill Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
CryoLife, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft Patency		1 to 3 years as defined by the date of their incident operation (CABG surgery).	No
Secondary	Morbidity		1 to 3 years defined by the date of their incident operation (CABG surgery)	No