Graft Imaging to Improve Patency (GRIIP)

Status: Completed
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

• isolated aortocoronary bypass surgery

• left ventricular ejection fraction >20%

• expect at least 2 bypass grafts

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre
Toronto
Time Frame
Start Date: July 2005
Completion Date: August 2009
Participants
Target number of participants: 156
Treatments
No Intervention: 1
Graft patency assessment by routine clinical assessment with/without intraluminal coronary probe
Experimental: 2
Graft patency assessment by indocyanine green angiography and transit-time flowmetry
Sponsors
Leads: Sunnybrook Health Sciences Centre
Collaborators: Heart and Stroke Foundation of Ontario

This content was sourced from clinicaltrials.gov

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