The purpose of this study is to determine whether the radial artery (artery in the arm) or saphenous vein (vein in the leg), when used as bypass grafts for coronary artery bypass surgery, have a greater patency rate (degree of opening)at 5 years after surgery.

Condition	Intervention	Phase
Coronary Arteriosclerosis	Procedure: Coronary artery bypass	Phase III

Further Study Details: 

Primary Outcomes: Angiographic patency rates of radial artery and long saphenous vein grafts to the native left circumflex territory
Secondary Outcomes: Safety/efficacy assessment; Physiological assessment of the randomized graft at angiography
Expected Total Enrollment:  200

Arteries differ from veins both in morphology and physiology. Thus the way they behave as in vivo conduits when used in coronary artery bypass grafting is also likely to be different. This may partly explain the predisposition of veins used as coronary conduits to accelerated atherosclerosis in comparison with the internal mammary artery grafts. There are presently few data describing the properties of the radial artery as an in-vivo coronary conduit over the longer-term.

The study will compare angiographic patency of the radial artery or saphenous vein graft anastomosed to the native left circumflex coronary territory at 3 months and 5 years after surgery. A substudy will compare 5-year post-surgery diameter and blood flow of in-vivo radial artery and saphenous vein grafts in response to endothelium-dependent and non-endothelium-dependent stimuli when patients attend for their scheduled follow-up angiogram.

Ages Eligible for Study:  40 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• on waiting list for clinically-indicated myocardial revascularization surgery
• aged 40-70 years
• significant stenosis (≥70%) in the circumflex territory as identified on preoperative angiograms
• negative Allen''''s test (defined as the return of palmar circulation within 5 seconds of releasing ulnar artery compression)
• willing to give written informed consent

Exclusion Criteria:

• poor LV function (EF <25%)
• severe diffuse peripheral vascular disease or bilateral varicose venous disease
• inability to comply with the angiographic follow-up at 3 months or/and 5 years

United Kingdom
      Royal Brompton & Harefield NHS Trust, London,  SW3 6NP,  United Kingdom

Study chairs or principal investigators

Neil E Moat, MS, FRCS,  Principal Investigator,  Royal Brompton & Harefield NHS Trust   

Study ID Numbers:  LREC 98-010
Last Updated:  August 30, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00139399
Health Authority: United Kingdom: Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-13