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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07485738
Status
Recruiting

Conditions

  • Blood Flow
  • CABG
  • CABG Graft Integrity
  • Heart Disease
  • Transit-time Flow Measurement

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Mar 30, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2032

Study Design

Enrollment
1,242 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Transit-Time Flow Measurement (TTFM)
    Use of TTFM during surgery
  • No Intervention: No Transit-Time Flow Measurement
    No TTFM during surgery

Primary Outcome Measure

Any Graft Failure [ Time Frame: 1 to 3 months after index CABG ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medicine/NewYork Presbyterian HospitalNew YorkNew York10022
SMARTFLOW Trial Listserv
(212) 746-5166
Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, F (PRINCIPAL_INVESTIGATOR)

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