Using Intraoperative Coronary Bypass Graft Imaging to Improve Graft Patency

NCT ID: NCT00187421

Last Updated: 2012-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2009-08-31

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

Conditions

Coronary Disease

Keywords

coronary disease; angiography; intraoperative care; vascular patency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Graft patency assessment by routine clinical assessment with/without intraluminal coronary probe

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

Graft patency assessment by indocyanine green angiography and transit-time flowmetry

Group Type: EXPERIMENTAL

Indocyanine green intraoperative angiogram and transit-time flowmetry

Intervention Type: PROCEDURE

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.

Interventions

Indocyanine green intraoperative angiogram and transit-time flowmetry

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.

Intervention Type: PROCEDURE

Other Intervention Names

Novadaq Spy System; Medtronic Medistem

Eligibility Criteria

Inclusion Criteria

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

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Stephen E. Fremes

Head , Division of Cardiac Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen E Fremes, MD,MSc,FRCSC

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiac and Vascular Surgery, Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

References

Singh SK, Desai ND, Chikazawa G, Tsuneyoshi H, Vincent J, Zagorski BM, Pen V, Moussa F, Cohen GN, Christakis GT, Fremes SE. The Graft Imaging to Improve Patency (GRIIP) clinical trial results. J Thorac Cardiovasc Surg. 2010 Feb;139(2):294-301, 301.e1. doi: 10.1016/j.jtcvs.2009.09.048. Epub 2009 Dec 16.

Reference Type: RESULT

PMID: 20006356 (View on PubMed)

Other Identifiers

HSF NA 5530

Identifier Type: -

Identifier Source: org_study_id