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FUnctional diagnoSIs of corONary Stenosis (FUSION) | Clinical Trials | Clareo Health

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FUnctional diagnoSIs of corONary Stenosis (FUSION)

Validation of OCT-based FUnctional diagnoSIs of corONary Stenosis (FUSION)

NCT04356027•Abbott Medical Devices

Summary

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).

Detailed Description

This study is a single-arm, prospective, multi-center study collecting OCT pullback images of lesions pre-percutaneous coronary intervention (PCI) and (optional) post-PCI procedure, and the corresponding pressure tracings and physiology indices. Up to 30 centers in the US will enroll approximately 310 patients. The expected duration of enrollment is approximately 15 months. The total duration of the clinical investigation is expected to be approximately 27 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

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
+21 more criteria

Locations (28)

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

Key Dates

Start Date

June 26, 2020

Primary Completion Date

October 15, 2021

Completion Date

October 15, 2021

Last Updated

February 21, 2025

Enrollment

312

ACTUAL participants

Conditions

Coronary Artery DiseaseCoronary Stenosis

Interventions

ICA (Invasive Coronary Angiography)

PROCEDURE

OCT

PROCEDURE

FFR

PROCEDURE

VFR Analysis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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FUnctional diagnoSIs of corONary Stenosis (FUSION)

Inclusion Criteria

Exclusion Criteria

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