Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery (RAPS - 5 years)
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|ClinicalTrials.gov Identifier: NCT00187356|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 5, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Procedure: Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories||Phase 3|
The multi-centre Radial Artery Patency Study, (RAPS) is a series of longitudinal graft patency studies designed to compare the long-term patency of the radial artery to the saphenous vein. Between 1996 and 2001, 561 patients were intraoperatively randomized to undergo surgery according to one of two strategies: radial-artery grafting to the circumflex territory and saphenous-vein grafting to the right coronary artery or radial-artery grafting to the right coronary artery and saphenous-vein grafting to the circumflex territory. The first study compared the 8-12 month angiographic patency of the radial artery with that of the saphenous vein as a conduit for coronary artery bypass and found that radial arteries were superior. The primary objective of this current study is to determine the beyond 5-year angiographic patency of the radial artery compared with a saphenous vein coronary bypass graft.
- The angiographic patency of radial artery grafts studied beyond 5 years following surgery exceeds that of saphenous vein grafts.
- Radial artery conduits studied beyond 5 years postoperatively have less graft disease than saphenous veins.
SAMPLE SIZE We expect to study 350 patients, which will allow us to test for a 35% risk reduction from 23% occlusion rate in saphenous veins to 15% in radial arteries, assuming a 5% within-patient correlation, with 80% power for a 2-tailed alpha of 0.05.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||269 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||October 2010|
Experimental: Surgical Conduit
The surgical arm will be composed of the experimental arm (the use of the radial artery) versus an active comparator (the use of the saphenous vein graft).
Procedure: Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories
Each patient will receive both study grafts (Radial artery and Study Saphenous vein graft). The within-patient randomization scheme will dictate whether the radial goes to the right or circumflex territory. The saphenous vein graft will go to the opposing territory.
- The primary endpoint will be the proportion of grafts which are functionally occluded (TIMI flow 0, 1, or 2). [ Time Frame: Beyond 5 years after bypass urgery ]
- a) the proportion of occluded study grafts (TIMI 0) [ Time Frame: Beyond 5 years after bypass urgery ]
- b) the proportion of functionally occluded grafts where proximal stenosis of native vessel is <90% vs >90% [ Time Frame: Beyond 5 years after bypass urgery ]
- c) the proportion of completely occluded grafts where proximal stenosis of native vessel is <90% vs >90% [ Time Frame: Beyond 5 years after bypass urgery ]
- d) proportion of study grafts with string sign [ Time Frame: Beyond 5 years after bypass urgery ]
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|Ages Eligible for Study:||30 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
The patient population consists of patients who were enroled into the original Multicentre Radial Artery Patency Study between November 1996 and January 2001. These included patients undergoing isolated coronary artery bypass surgery less than 80 years of age with 3 vessel coronary disease and left ventricular ejection fraction greater than 35%.
Exclusion criteria included 1: Inability to use the radial artery or saphenous vein conduits: a)nonpalpable ulnar arteries or a positive Allen's test, b) an abnormal Doppler study or ultrasonographic study of the arms, c) a history of vasculitis or Raynaud's syndrome, bilateral varicose veins or vein stripping. 2: Conditions that affected the safety of follow-up angiography: a)renal insufficiency (creatinine > 180 umol/L) b)severe peripheral vascular disease precluding femoral access b)coagulopathy or obligatory uninterrupted use of anticoagulants c) known allergy to radiographic contrast media d) women of childbearing potential e) comorbid illness which precludes the use of follow up angiography f) geographically inaccessible for follow up angiography.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187356
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2B7|
|Manitoba Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|London Health Sciences Centre - UC|
|London, Ontario, Canada, N6A 5A5|
|London Health Sciences Centre - VC|
|London, Ontario, Canada, N6B1B1|
|Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Sunnybrook and Women's College HSC|
|Toronto, Ontario, Canada, M4N3M5|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B1W8|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G2C4|
|Vancouver General Hospital|
|Vancouver, Ontario, Canada, V5Z1C6|
|Laval, Quebec, Canada, G1V4G5|
|Montreal Heart Institute|
|Montreal, Quebec, Canada, H1T 1C8|
|Montreal Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|Hamilton, New Zealand|
|Study Chair:||Stephen E Fremes, MD||Sunnybrook Health Sciences Centre|
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Stephen E. Fremes, Head, Division of Cardiac and Vascular Surgery and Dr. Bernard S. Goldman Chair in Cardiovascular Surgery, Sunnybrook Health Sciences Centre|
|Other Study ID Numbers:||
CIHR MCT# 52681
|First Posted:||September 16, 2005 Key Record Dates|
|Last Update Posted:||June 5, 2013|
|Last Verified:||June 2013|
Coronary Bypass Surgery
Coronary Artery Disease
Coronary Artery Disease
Arterial Occlusive Diseases