Back to resultsEvaluation of Graft Material in Coronary Artery Bypass Grafting (CABG)
Primary Purpose
Angina Pectoris
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Coronary artery bypass grafting
Sponsored by
About this trial
This is an interventional treatment trial for Angina Pectoris focused on measuring CABG, LIMA, saphenous vein, radial artery
Eligibility Criteria
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.
Sites / Locations
- Dept of Cardiothoracic Surgery, Orebro University Hospital
Outcomes
Primary Outcome Measures
Functional grafts defined as opened or closed.
Secondary Outcome Measures
Degree of stenosis in implanted grafts.
Full Information
NCT ID
NCT01310725
First Posted
March 7, 2011
Last Updated
March 7, 2011
Sponsor
Region Örebro County
Collaborators
Swedish Heart Lung Foundation, Regional Clinical Research
1. Study Identification
Unique Protocol Identification Number
NCT01310725
Brief Title
Evaluation of Graft Material in Coronary Artery Bypass Grafting (CABG)
Official Title
Mid-term Patency of Radial Artery and No Touch Saphenous Vein as Grafts in CABG; A Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Region Örebro County
Collaborators
Swedish Heart Lung Foundation, Regional Clinical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris
Keywords
CABG, LIMA, saphenous vein, radial artery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Coronary artery bypass grafting
Intervention Description
Bypass of stenoses in coronary arteries using different types os vessels as conduit.
Primary Outcome Measure Information:
Title
Functional grafts defined as opened or closed.
Time Frame
Up to 5 years after surgery.
Secondary Outcome Measure Information:
Title
Degree of stenosis in implanted grafts.
Time Frame
Up to 5 years after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Norgren, MD, PhD, Prof.
Organizational Affiliation
OREBRO UNIVERSITY
Official's Role
Study Chair
Facility Information:
Facility Name
Dept of Cardiothoracic Surgery, Orebro University Hospital
City
Orebro
ZIP/Postal Code
701 85
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Graft Material in Coronary Artery Bypass Grafting (CABG)
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