Evaluation of Graft Material in Coronary Artery Bypass Grafting (CABG)

Not Applicable

Completed

• Conditions: Angina Pectoris

• Registration Number: NCT01310725
• Lead Sponsor: Region Örebro County

Brief Summary

The aim of the study is to evaluate the patency in different kinds of vessels used as graft material in coronary artery bypass grafting.

The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the same, or better, patency compared to radial grafts and that skeletonisation of the left internal mammary artery does not effect the patency for this graft.

Detailed Description

Patients undergoing coronary artery bypass grafting are included in the study.

Each patient receive a radial artery graft and a vein graft harvested with a pedicle of surrounding tissue to the right and left side of the heart respectively. The left internal mammary artery is used for the left anterior descending artery in a skeletonised or non-skeletonised fashion.

The evaluation is made with angiography up to 5 years after surgery.

Study Timeline

• Study Start: 2004-01
• Status Verified: 2010-09
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-07
• Last Update Submitted: 2011-03-07
• Study First Posted: 2011-03-08
• Last Update Posted: 2011-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Isolated coronary artery disease embracing all three main branches of the coronary artery tree.

Exclusion Criteria

• Kidney insufficiency (Creatinine > 120 µmol/L)
• War-farin anticoagulation therapy
• Ejection fraction < 40%
• Repeat operation
• Other concurrent sur-gery
• Signs of reduced circulation in non-dominant hand
• Other severe illness, or if the patient declines to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Functional grafts defined as opened or closed.	Up to 5 years after surgery.

Secondary Outcome Measures

Name	Time	Method
Degree of stenosis in implanted grafts.	Up to 5 years after surgery.

Trial Locations

Locations (1)

Dept of Cardiothoracic Surgery, Orebro University Hospital; 🇸🇪 Orebro, Sweden