NCT06471062|Not Yet Recruiting
Transit Time Flow Measurement in Coronary Surgery
COLLATERAL
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COLLATERAL
Sponsor study identifier
observational
135
1 country
1
Study Start
November 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 20, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 20, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Transit-time flowmetry (TTFM) allows grafts quality control during coronary artery bypass surgery by measuring the flow volume through them. To date, many studies have deeply studied the predictive role on the graft outcomes of the various flowmetry-derived parameters. One of the least investigated aspects, however, is the mutual influence that two newly realized grafts can have. This possibility would be related to the presence of a more or less developed collateral circulation between the bypassed territories. The purpose of this study is to assess whether a graft for a territory different than that provided by the left anterior descending artery (LAD) may affect the functionality (measured through flowmetry) of the left internal mammary artery - LAD graft.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 20, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 28, 2024
Actual (reported)June 24, 2024
Actual (reported)November 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 20, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 20, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
LIMA>LAD Pulsatility index (PI) modification
The primary aim of this study is to assess whether a graft for a non-LAD coronary target modifies the performance (measured by flowmetry) of the flow in the LIMA\>LAD graft. PI is expressed by the ratio of the flow volume amplitude and mean flow volume, both quantified by a flowmeter (ml/min / ml/min). An ideal value would be \< 3
During the surgery, out of cardiopulmonary bypass
LIMA>LAD mean flow change
During surgery, before and after transient occlusion of the other grafts for non-LAD coronary targets
LIMA>LAD Diastolic filling (%DF) change
During surgery,before and after transient occlusion of the other grafts for non-LAD coronary targets.
All patients with coronary artery disease and an indication for surgical revascularization (coronary artery bypass grafting) who meet the above-described inclusion and exclusion criteria will be enrolled by signing the informed consent the day before surgery.
Fondazione Policlinico Gemelli IRCCS
Roma, Italy
federico cammertoni
Fondazione Policlinico Gemelli IRCCS
First Submitted
May 28, 2024
First Posted
June 24, 2024
Study Start
November 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 20, 2025
IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
variation of Diastolic filling (%DF) on the right coronary
During surgery,before and after transient occlusion of the other grafts for non-LAD coronary targets.
LIMA>LAD % Backward flow (BF) change
During surgery, before and after transient occlusion of the other grafts for non-LAD coronary targets.
mean flow, Pulsatility Index, Diastolic filling (%DF) and Diastolic filling (%DF) in the non-LAD grafts
During surgery, before and after transient occlusion of the LIMA>LAD graft
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 20, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 27, 2024
Record last verified: 2024-11
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