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| Name | Class |
|---|---|
| Medistim ASA | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transit-Time Flow Measurement (TTFM) | Active Comparator | Use of TTFM during surgery |
|
| No Transit-Time Flow Measurement | No Intervention | No TTFM during surgery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Any Graft Failure | The primary outcome of SMARTFLOW:Patency is any graft failure | 1 to 3 months after index CABG |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 10 years of randomization |
| Time-averaged change from baseline in Seattle Angina Questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SMARTFLOW Trial Listserv | Contact | (212) 746-5460 | smartflow@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine/NewYork Presbyterian Hospital | Recruiting | New York | New York | 10022 | United States |
Individual participant data that underlie the results to be reported, after de-identification (text, tables, figures, and appendices).
Beginning 12 months and ending 26 months following article publication.
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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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.
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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 |
| Within 10 years of randomization |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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