CABG Graft IntegritySMARTFLOWNCT07485738
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
A study testing Transit-Time Flow Measurement (TTFM) in people with CABG Graft Integrity and CABG, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CABG Graft Integrity, CABG, Blood Flow
- What is being tested?
- Transit-Time Flow Measurement (TTFM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,242 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2026to Mar 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine/NewYork Presbyterian Hospital
New York, New York, 10022
SMARTFLOW Trial Listserv, (212) 746-5166, SMARTFLOW@med.cornell.edu
Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, F
About this study
Official title: 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
Read the 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.
- Being tested
- Transit-Time Flow Measurement (TTFM)
- Keywords
- SMARTFLOW
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Transit-Time Flow Measurement (TTFM) | Active comparator | Use of TTFM during surgery Receives: Device: Transit-Time Flow Measurement (TTFM) |
| No Transit-Time Flow Measurement | No intervention | No TTFM during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any Graft Failure
The primary outcome of SMARTFLOW:Patency is any graft failure
Measured: 1 to 3 months after index CABG
Secondary outcomes (2)
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
Measured: 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
Measured: Within 10 years of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start30 Mar 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABG Graft IntegrityStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Medistim ASA
- Responsible party
- Sponsor
- Investigators
- Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485738
- Sponsor's protocol ID
- 25-05028936
- Acronym
- SMARTFLOW
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results to be reported, after de-identification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Measurement for Accurate Revascularization Using Transit-time FLOW (SMARTFLOW):Patency
- ClinicalTrials.gov ID
- NCT07485738
- Acronym / sponsor ID
- SMARTFLOW / 25-05028936
- Keywords
- SMARTFLOW
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,242 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Medistim ASA
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transit-Time Flow Measurement (TTFM) | Active comparator | Device: Transit-Time Flow Measurement (TTFM)Use of TTFM during surgery |
| No Transit-Time Flow Measurement | No intervention | –No TTFM during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Reoperation
- Emergency procedures
- Combined CABG + other cardiac or non-cardiac surgery
- Isolated single vessel CABG
- Minimally invasive CABG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Transit-Time Flow Measurement (TTFM) |
Primary outcome
Any Graft Failure
Time frame: 1 to 3 months after index CABG
The primary outcome of SMARTFLOW:Patency is any graft failure
2 secondary outcomes
Time to the occurrence of major adverse cardiac event (MACE)
Time frame: Within 10 years of randomization
Time-averaged change from baseline in Seattle Angina Questionnaire.
Time frame: Within 10 years of randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results to be reported, after de-identification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transit-Time Flow Measurement (TTFM) in people with CABG Graft Integrity and CABG, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SMARTFLOW Trial Listserv ((212) 746-5460, smartflow@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any Graft Failure (time frame: 1 to 3 months after index CABG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.