The purpose of this study is to learn more about a tool called Transit-Time Flow Measurement (TTFM). TTFM uses sound waves during surgery to check how well blood is flowing through blood vessels. This helps doctors see if the blood flow is good during coronary artery bypass grafting (CABG), which is a type of heart surgery
The SMARTFLOW:Patency trial is designed to fill this critical evidence gap by evaluating the impact of CABG graft quality assessment by TTFM on clinical outcomes in a large randomized cohort. SMARTFLOW:Patency will evaluate the impact of CABG graft quality assessment by TTFM on graft patency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,242
TTFM is based on ultrasound technology and allows the assessment of intraoperative graft function based on quantification, directionality and resistance to blood flow through the graft.
Weill Cornell Medicine/NewYork Presbyterian Hospital
New York, New York, United States
Any Graft Failure
The primary outcome of SMARTFLOW:Patency is any graft failure
Time frame: 1 to 3 months after index CABG
Time to the occurrence of major adverse cardiac event (MACE)
Time to the occurrence of major adverse cardiac event (MACE), defined as the composite of death, myocardial infarction or target vessel revascularization
Time frame: Within 10 years of randomization
Time-averaged change from baseline in Seattle Angina Questionnaire.
The Seattle Angina Questionnaire (SAQ) is a validated 19-item self-administered survey used to measure the functional status and quality of life in patients with coronary artery disease
Time frame: Within 10 years of randomization
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