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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transit-Time Flow Measurement (TTFM).
- Who it may be relevant to
- Registry conditions: CABG Graft Integrity, CABG, Blood Flow, Transit-time Flow Measurement. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Surgical Measurement for Accurate Revascularization Using Transit-time FLOW (SMARTFLOW):Patency
Overview
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.
Interventions
- 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.
Primary outcome measures
- Any Graft Failure [Time frame: 1 to 3 months after index CABG]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Weill Cornell Medicine/NewYork Presbyterian Hospital — New York
Identifiers
NCT: NCT07485738 · 25-05028936