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 (SMARTFLOW)

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

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

Study Overview

• Status: Recruiting
• Conditions: CABG; Heart Disease; Blood Flow; CABG Graft Integrity; Transit-time Flow Measurement
• Intervention / Treatment: Device: Transit-Time Flow Measurement (TTFM)

Detailed Description

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
• Enrollment (Estimated): 1242
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SMARTFLOW Trial Listserv; Phone Number: (212) 746-5460; Email: smartflow@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Recruiting
      • Weill Cornell Medicine/NewYork Presbyterian Hospital
      • Contact: SMARTFLOW Trial Listserv; Phone Number: (212) 746-5166; Email: SMARTFLOW@med.cornell.edu
      • Principal Investigator: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, F

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transit-Time Flow Measurement (TTFM); Use of TTFM during surgery	Device: 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.
No Intervention: No Transit-Time Flow Measurement; No TTFM during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any Graft Failure	The primary outcome of SMARTFLOW:Patency is any graft failure	1 to 3 months after index CABG

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Within 10 years of randomization

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Medistim ASA
• Investigators: Principal Investigator: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2032

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: SMARTFLOW
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 25-05028936

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results to be reported, after de-identification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 12 months and ending 26 months following article publication.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No