Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07485738

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

CABG Graft Integrity Blood Flow CABG Cardiovascular Diseases Heart Disease Heart Diseases Transit-time Flow Measurement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine/NewYork Presbyterian Hospital

New York, 10022, United States

Location status: Recruiting

Location contact

Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, F

PRINCIPAL_INVESTIGATOR

SMARTFLOW Trial Listserv

CONTACT

[email protected]

(212) 746-5166

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Reoperation
  • Emergency procedures
  • Combined CABG + other cardiac or non-cardiac surgery
  • Isolated single vessel CABG
  • Minimally invasive CABG
  • Inability to undergo coronary computed tomographic angiography (CCTA)
  • Unable to provide written informed consent or comply with all the study procedures.

Treatment and study plan

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.

Primary outcomes

  1. Any Graft Failure

    Time frame: 1 to 3 months after index CABG

    The primary outcome of SMARTFLOW:Patency is any graft failure

Secondary outcomes

  1. Time to the occurrence of major adverse cardiac event (MACE)

    Time frame: Within 10 years of randomization

    Time to the occurrence of major adverse cardiac event (MACE), defined as the composite of death, myocardial infarction or target vessel revascularization

  2. Time-averaged change from baseline in Seattle Angina Questionnaire.

    Time frame: Within 10 years of randomization

    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

Study contacts

Contact information is provided by the study sponsor or research team.

SMARTFLOW Trial Listserv

CONTACT

[email protected]

(212) 746-5460

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Medistim ASA

Registry information

Official study title

Surgical Measurement for Accurate Revascularization Using Transit-time FLOW (SMARTFLOW):Patency

Acronym: SMARTFLOW

Important dates

Study start
2026
Primary completion
2029
Study completion
2032
First posted
Mar 20, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.