Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187421
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2005-09-14
Brief Title:
Using Intraoperative Coronary Bypass Graft Imaging to Improve Graft Patency
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Graft Imaging to Improve Patency GRIIP
Status:
COMPLETED
Status Verified Date:
2012-12
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:
GRIIP
Brief Summary:
The primary objective of the proposed study is to determine if a strategy of intraoperative patency assessment and graft revision can decrease the rate of graft occlusion or significant stenosis 50 at 6-12 weeks after coronary artery bypass grafting CABG versus traditional operative management without routine intraoperative patency assessment Patency will be assessed with a new fluorescence angiography technique as well as ultrasonic transit-time flow measurement We hypothesize that the strategy of intraoperative patency assessment and graft revision will significantly reduce the frequency of graft occlusion at 6-12 weeks in comparison to patients who do not have intraoperative patency assessment We also hypothesize that the strategy of intraoperative patency assessment and graft revision will significantly reduce the frequency of 50-99 stenoses at 6-12 weeks in comparison to patients who do not have intraoperative patency assessment We expect both groups will experience similar perioperative outcomes but hypothesize that patients receiving a strategy of intraoperative patency assessment and graft revision will experience improved long-term graft patency and freedom from late clinical events at 5-6 years post-operatively
Detailed Description:
The immediate and long term success of coronary surgery is dependent on the construction of a high quality anastomosis with a durable conduit to an appropriate target coronary vessel Significant advances in medical therapy including early post-operative aspirin administration and increased use of arterial grafting have improved early midterm and late graft patency However modern coronary bypass series continue to report perioperative graft occlusions rates as high as 11 These very early graft failures have been predominantly ascribed to technical problems at graft anastomosis sites and may be preventable New intraoperative graft assessment technologies have recently become available which can identify technical problems such that they can be repaired in the operating room However these techniques increase the length of the bypass operation and may have false positives which may lead to unnecessary and potentially damaging graft revisions The primary objective of the proposed study is to determine if a strategy of intraoperative patency assessment and graft revision can decrease the rate of graft occlusion or significant stenosis50 at 6-12 weeks after coronary artery bypass grafting CABG versus traditional operative management without routine intraoperative patency assessment
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