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

NCT07485738 | Recruiting DMC FDA Device

• 1 other identifier: 25-05028936
• Study Type: interventional
• Target: 1,242
• Locations: 1 country
• Sites: 1

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

Keywords

SMARTFLOW

Outcome Measures

Primary Outcomes (1)

• Any Graft Failure

  The primary outcome of SMARTFLOW:Patency is any graft failure

  1 to 3 months after index CABG

Secondary Outcomes (2)

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

  Within 10 years of randomization

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

  Within 10 years of randomization

Study Arms (2)

Transit-Time Flow Measurement (TTFM)

ACTIVE COMPARATOR

Use of TTFM during surgery

Device: Transit-Time Flow Measurement (TTFM)

No Transit-Time Flow Measurement

NO INTERVENTION

No TTFM during surgery

Interventions

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.

Transit-Time Flow Measurement (TTFM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medistim ASA: collaborator
• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine/NewYork Presbyterian Hospital

New York, New York, 10022, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

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

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SMARTFLOW Trial Listserv

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SMARTFLOW:Patency is an expertise-based, double-blind, multicenter, 1:1 randomized clinical trial. The trial will compare use of TTFM versus non-use of TTFM for reduction of graft failure in patients undergoing CABG.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 20, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2032
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 12 months and ending 26 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

US (1)