FUnctional diagnoSIs of corONary Stenosis (FUSION)

Completed

Conditions studied: Coronary Artery Disease, Coronary Stenosis

In brief

The purpose of the FUSION study is to validate the diagnostic performance of Virtual Flow Reserve (VFR) by comparing it against a reference standard, fractional flow reserve (FFR).

Key facts

Study ID

NCT04356027

Run by

Abbott Medical Devices

People needed

312

Starts

2020-06-26

Expected to finish

2021-10-15

Last updated by the study team

2025-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Patient provides written informed consent
• Scheduled for clinically indicated coronary catheterization with the intent to perform physiologic assessment to guide physician clinical course (in lesions with visual % diameter stenosis 40-90%), if clinically indicated
• Subject is undergoing invasive FFR with Adenosine (high-dose intra-coronary (IC) [200 μg for the left and or 100 μg for the right coronary artery] or 140 μg/kg/min for intravenous (IV)) used as hyperemic stimulus
• Clinical presentation with or history of stable angina, unstable angina, or silent ischemia (defined as abnormal stress test or abnormal invasive physiology assessment) that has led to the procedure
• General Exclusion Criteria:
• Prior history of myocardial infarction (MI) in the target vessel
• Presence of acute ST Elevation Myocardial Infarction (STEMI)
• Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI)
• TIMI flow < Grade 3 at baseline or visible thrombus
• Prior history of coronary artery bypass grafting (CABG)
• Prior heart transplant
• Severe valvular heart disease or history of valve repair or replacement
• Prior history of PCI with stent in target vessel, or target vessel involves in-stent restenosis.
• Target coronary vessel is supplied by major collaterals or is supplying major collaterals to a CTO (chronic total occlusion)
• CTO in the target vessel
• Severe diffuse disease observed in target vessel defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree
• Presence of myocardial bridge (MB), regardless of vessel location
• Contraindication for FFR examination or administration of vasodilators
• Known LVEF ≤45%
• Target lesion involves Left Main coronary artery or ostial right coronary artery
• Known renal insufficiency (eGFR < 30 ml/kg/m\^2 or serum creatinine ≥ 2.5 mg/dL) unless patient is on dialysis
• Heart Failure NYHA Class III or IV
• Subject is pregnant (For a female subject of childbearing potential, a pregnancy test must be performed within 14 days (≤14 days) prior to the index procedure per site standard test)
• Subject has or had active COVID-19 symptoms and/or a positive test result within the prior 2 months

Where it is running

• Heart Center Research, LLC. — Huntsville, Alabama, United States
• HonorHealth — Scottsdale, Arizona, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• VA Palo Alto Medical Center — Palo Alto, California, United States
• UCLA Medical Center Santa Monica — Santa Monica, California, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• The Cardiac & Vascular Institute Research Foundation, LLC — Gainesville, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Atlanta VA Medical Center — Decatur, Georgia, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Via Christi Regional Medical Center - St. Francis Campus — Wichita, Kansas, United States
• Cardiovascular Research Institute of Kansas — Wichita, Kansas, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Mercy Hospital — Coon Rapids, Minnesota, United States
• St. Patrick Hospital — Missoula, Montana, United States
• New York University Hospital — New York, New York, United States
• New York-Presbyterian/Columbia University Medical Center — New York, New York, United States
• St. Francis Hospital — Roslyn, New York, United States
• Montefiore Medical Center - Moses Division — The Bronx, New York, United States
• VA Medical Center Durham — Durham, North Carolina, United States
• Providence St. Vincent Medical Center — Portland, Oregon, United States
• Holy Spirit Hospital — Camp Hill, Pennsylvania, United States
• Greenville Health System — Greenville, South Carolina, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States

Full record on ClinicalTrials.gov

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