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The Relationship Between Blood Flow Readings During Surgery and How Well the Graft Stays Open and How Patients Recover Afterward in Coronary Artery Bypass Graft Surgery

ConditionsCABG Graft IntegrityCABGBlood FlowTransit-time Flow MeasurementHeart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

First-time, non-emergent isolated multivessel CABG through median sternotomy

Willing and able to provide written informed consent and comply with all study procedures, including QOL questionnaires

Disqualifiers

Reoperation

Emergency procedures

Combined CABG + other cardiac or non-cardiac surgery

Isolated single vessel CABG

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transit-Time Flow Measurement (TTFM)

    Device

    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.

Treatment groups

1,242 Participants
are divided into 2 treatment groups
Group A: Transit-Time Flow Measurement (TTFM)Active comparator 1 intervention
Group B: No Transit-Time Flow MeasurementNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Any Graft Failure

The primary outcome of SMARTFLOW:Patency is any graft failure

Time frame
1 to 3 months after index CABG

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

Medistim ASA

Collaborator

Source ClinicalTrials.gov
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