Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
NCT Number: NCT00187421
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Phase 3
Toronto, Ontario, M4N 3M5, Canada
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 stenosis(>50%) at 6-12 weeks after coronary artery bypass grafting (CABG) versus traditional operative management without routine intraoperative patency assessment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ICG graft angiography following each distal anastomosis, and imaging of proximal anastomoses after all grafts completed.
transit time flowmetry performed on all grafts after all grafts completed.
Other names: Novadaq Spy System, Medtronic Medistem
Time frame: 4 days to 4 months following surgery
Time frame: 4 day to 4 months postoperatively
Time frame: Perioperatively
Time frame: 1 year postoperatively
Sunnybrook Health Sciences Centre
Other
Graft Imaging to Improve Patency (GRIIP)
Acronym: GRIIP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03188705
Arterial Occlusive Diseases, Arteriosclerosis
Lancaster, Pennsylvania, United States
View Trial DetailsNCT02579655
Brain Diseases, Cardiovascular Diseases
Calgary, Alberta, Canada
View Trial DetailsNCT04580017
Angina Pectoris, Angina, Unstable
Hammam Sousse, Sousse Governorate, Tunisia
View Trial DetailsNCT00248352
Arterial Occlusive Diseases, Arteriosclerosis
Ottawa, Ontario, Canada
View Trial Details