Using blood flow measurements during bypass surgery to predict graft openness and recovery
Official title: Surgical Measurement for Accurate Revascularization Using Transit-time FLOW (SMARTFLOW):Patency
Run by Weill Medical College of Cornell University · NCT07485738 · Data updated 2026-11-12
This trial will test whether using a device that measures blood flow during coronary bypass surgery helps surgeons ensure grafts stay open and improves recovery for adults having their first non-emergency multivessel CABG.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1242 (estimated) |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | March 30, 2026 |
| Main results expected | March 2029 |
| Study ends | March 2032 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT07485738 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 having a first-time, non-emergency isolated multivessel CABG through median sternotomy who can undergo CCTA and provide informed consent are ideal candidates.
✕Probably not a fit
Patients undergoing reoperation, emergency or combined procedures, isolated single-vessel or minimally invasive CABG, those unable to undergo CCTA, or those who cannot consent are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
SMARTFLOW:Patency randomizes adults having first-time, non-emergency multivessel coronary artery bypass grafting to intraoperative Transit-Time Flow Measurement (TTFM) versus usual care. TTFM uses ultrasound-based sound waves during surgery to measure blood flow through each graft and can prompt immediate graft revision if flow readings are poor. Graft patency will be checked after surgery using coronary CT angiography (CCTA) and patients will have clinical follow-up to track recovery. The trial is designed to determine whether routine use of TTFM leads to higher rates of open grafts and improved postoperative outcomes.
Why it matters
Potential benefit: If successful, using TTFM during CABG could reduce early graft failures and improve recovery by allowing surgeons to identify and fix poor grafts during the operation.
How similar studies have gone: Smaller observational and single-center studies suggest TTFM can detect technical graft problems, but large randomized evidence showing improved graft patency or clinical outcomes is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Weill Cornell Medicine/NewYork Presbyterian Hospital
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC — Weill Medical College of Cornell University
- Study coordinator: SMARTFLOW Trial Listserv
- Email: smartflow@med.cornell.edu
- Phone: (212) 746-5460
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.