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Sponsors and Collaborators: |
Rigshospitalet, Denmark Danish Heart Foundation The Lundbeck Foundation Copenhagen Hospital Corporation |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00159991 |
There is a remarkable lack of randomized trials concerning the potential benefit of using arterial conduits for coronary bypass surgery. This is the purpose of the present trial. Exclusive use of arterial conduits might result in improved conduit viability, reduced risk of recurrent angina, myocardial infarction and other cardiac events, reduced need for antianginal medication, improved functional status and possibly improved long term survival. The patients will be followed for ten years after surgery.
Condition | Intervention | Phase |
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Coronary Arteriosclerosis Ischemic Heart Disease Angina Pectoris |
Procedure: Total arterial revascularization Procedure: Conventional revascularization |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Arterial Revascularization for Coronary Bypass Surgery: A Randomized Trial Comparing the Outcome After Using LIMA + Vein Grafts Versus Total Arterial Revascularization With LIMA + RIMA + Radial Artery Grafts |
Enrollment: | 331 |
Study Start Date: | February 2002 |
Estimated Study Completion Date: | February 2015 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Total arterial revascularization
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Procedure: Total arterial revascularization
Coronary artery bypass grafting using LIMA and RIMA and/or radial artery grafts
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B: Active Comparator
Conventional revascularization
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Procedure: Conventional revascularization
Coronary artery bypass grafting using LIMA and saphenous vein grafts
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Department of Cardiothoracic Surgery, Rigshospitalet | |
Copenhagen, Denmark, 2100 |
Principal Investigator: | Sune Damgaard, MD | Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen |
Study Director: | Daniel A Steinbrüchel, Professor | Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen |
Study Chair: | Jens T Lund, Consultant | Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen |
Study Chair: | Henning Kelbæk, Consultant | Cardiac Cath. Lab., Rigshospitalet, Copenhagen |
Study Chair: | Jan K Madsen, Consultant | Dept. of Cardiology, Gentofte County Hospital, Copenhagen |
Responsible Party: | Department of Cardiothoracic Surgery, Rigshospitalet ( Sune Damgaard MD ) |
Study ID Numbers: | 961502837 |
Study First Received: | September 8, 2005 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00159991 |
Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Coronary artery bypass grafting Total arterial revascularization Internal mammary artery grafting Radial artery grafting |
Arterial Occlusive Diseases Coronary Disease Signs and Symptoms Heart Diseases Myocardial Ischemia Vascular Diseases |
Angina Pectoris Pain Ischemia Arteriosclerosis Coronary Artery Disease Chest Pain |
Cardiovascular Diseases |