Vein vs Arterial Grafts for Coronary Artery Bypass Grafting Surgery
Primary Purpose
Angina Pectoris
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
NT SVG grafts
Sponsored by
About this trial
This is an interventional treatment trial for Angina Pectoris focused on measuring CABG, Saphenous vein, Radial artery
Eligibility Criteria
Inclusion Criteria:
- Three vessel coronary artery disease
Exclusion Criteria:
- 65 years or older
- Elevated creatinine
- Raynauds disease
- Vein stripping
Sites / Locations
- University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NT SVG grafts
RA grafts
Arm Description
NT SVG randomized for revascularization of left or right coronary territory
RA grafts randomized for revascularization of left or right coronary territory
Outcomes
Primary Outcome Measures
Graft patency
The grafts will be categorized as either "open" or "closed". A stenosis of the graft exceeding 70 % of the lumen diameter will be considered as "closed".
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02158455
Brief Title
Vein vs Arterial Grafts for Coronary Artery Bypass Grafting Surgery
Official Title
No-touch Saphenous Vein Grafts vs Radial Artery Grafts; A Randomized Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2004 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Örebro County
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators have developed a novel technique for saphenous vein graft harvesting for coronary artery bypass grafting (CABG) where the graft is harvested with a pedicle of surrounding tissue. A randomized trial has shown a significantly higher patency rate for vein grafts harvested with this new methode compared to conventional harvesting technique 8.5 years after surgery (90 vs 76 %). In 2004 the investigators started a prospective randomized trial comparing patency between vein grafts harvested with surrounding tissue and radial artery grafts. The result showed that vein grafts harvested with surrounding tissue had a significantly higher patency rate compared to radial artery grafts 3 years after surgery (98 vs 84 %). The present study is a long-term follow-up (8 years) of the patients included in the second randomized trial. The hypothesis is that vein grafts harvested with surrounding tissue have a significantly higher patency rate compared to radial artery grafts 8 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, Saphenous vein, Radial artery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NT SVG grafts
Arm Type
Experimental
Arm Description
NT SVG randomized for revascularization of left or right coronary territory
Arm Title
RA grafts
Arm Type
Active Comparator
Arm Description
RA grafts randomized for revascularization of left or right coronary territory
Intervention Type
Procedure
Intervention Name(s)
NT SVG grafts
Primary Outcome Measure Information:
Title
Graft patency
Description
The grafts will be categorized as either "open" or "closed". A stenosis of the graft exceeding 70 % of the lumen diameter will be considered as "closed".
Time Frame
5 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Three vessel coronary artery disease
Exclusion Criteria:
65 years or older
Elevated creatinine
Raynauds disease
Vein stripping
Facility Information:
Facility Name
University hospital
City
Orebro
ZIP/Postal Code
70185
Country
Sweden
12. IPD Sharing Statement
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Vein vs Arterial Grafts for Coronary Artery Bypass Grafting Surgery
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