Recruiting

Transit-Time Flow MeasurementThe 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

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07485738

Conditions

CABG Graft Integrity

CABG

Blood Flow

Transit-time Flow Measurement

Heart Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transit-Time Flow Measurement (TTFM)

Study Details

Brief summary:

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

Conditions

CABG Graft Integrity

CABG

Blood Flow

Transit-time Flow Measurement

Heart Disease

Study ID

NCT07485738

Start date

Mar 30, 2026

Status verified date

Apr, 2026

Completion date

Mar, 2032

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age >18 years
2. First-time, non-emergent isolated multivessel CABG through median sternotomy
3. Willing and able to provide written informed consent and comply with all study procedures, including QOL questionnaires

Exclusion Criteria:

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

Study Design

Enrollment

1242 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Transit-Time Flow Measurement (TTFM)

Use of TTFM during surgery

no intervention: No Transit-Time Flow Measurement

No TTFM during surgery

Interventions

Transit-Time Flow Measurement (TTFM)

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 outcome measure

Any Graft Failure [ Time Frame: 1 to 3 months after index CABG ]

Central Contacts and Locations

Central contacts

SMARTFLOW Trial Listserv

(212) 746-5460 smartflow@med.cornell.edu

Locations

Weill Cornell Medicine/NewYork Presbyterian Hospital

Recruiting

New York, New York, United States, 10022

Contacts

SMARTFLOW Trial Listserv

(212) 746-5166 SMARTFLOW@med.cornell.edu

Principal Investigator:

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

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

SMARTFLOW

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-04-22.