Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187356
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2005-09-10
Brief Title:
Multicentre Radial Artery Patency Study Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Multicentre Radial Artery Patency Study Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPS - 5 years
Brief Summary:
Bypass surgery is often required to treat severe coronary heart disease Either arteries or veins can be used as bypass grafts We wish to compare the long-term durability of the saphenous vein from the leg to that of the radial artery from the fore-arm when used as bypass grafts We are examining how many of these grafts are still functioning beyond 5 years after bypass surgery by performing a coronary angiogram After 1-year we found that radial arteries were more likely to be functioning than saphenous veins We hypothesize that radial arteries will continue to be superior beyond 5 years
Detailed Description:
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
HYPOTHESES
1 The angiographic patency of radial artery grafts studied beyond 5 years following surgery exceeds that of saphenous vein grafts
2 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 005
HYPOTHESES
1 The angiographic patency of radial artery grafts studied beyond 5 years following surgery exceeds that of saphenous vein grafts
2 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None