Using Intraoperative Coronary Bypass Graft Imaging to Improve Graft Patency

Phase

Condition

Coronary Artery Disease

Thrombosis

Cardiac Disease

Treatment

N/A

Clinical Study ID

NCT00187421

HSF NA 5530

All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

isolated aortocoronary bypass surgery
left ventricular ejection fraction >20%
expect at least 2 bypass grafts

Exclusion

Exclusion Criteria:

renal insufficiency (creatinine >180 umol/L)
known allergy to indocyanine green contrast dye
severe peripheral vascular disease precluding femoral access
known allergy to radiographic contrast media
women of childbearing potential
co-morbid illness which precludes the use of follow-up angiography
geographically inaccessible for follow-up angiography

Study Design

July 01, 2005

August 31, 2009

Study 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 stenosis(>50%) at 6-12 weeks after coronary artery bypass grafting (CABG) versus traditional operative management without routine intraoperative patency assessment.

Connect with a study center

Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
Canada
Site Not Available

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