FUnctional diagnoSIs of corONary Stenosis (FUSION)

NCT04356027 | Completed Results DMC

• 1 other identifier: ABT-CIP-10331
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 28

Brief 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).

Conditions

Coronary Artery Disease; Coronary Stenosis

Keywords

Virtual Flow Reserve (VFR); Optical Coherence Tomography (OCT); Fractional Flow Reserve (FFR); Percutaneous Coronary Intervention (PCI); OPTIS System; Dragonfly; PressureWire X

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR)

  Sensitivity and specificity of the VFR compared with FFR each of which will be tested against a prespecified performance goal. FFR with a binary cut-off of 0.80 will be used as the reference standard for comparison. FFR or VFR value ≤ 0.80 will be considered positive (ischemia-causing), and FFR or VFR value \> 0.80 will be considered negative (non-ischemia-causing). Sensitivity is defined as the percentage of VFR positive lesions, in the group of FFR positive lesions. Sensitivity=TP/(TP+FN) x 100%, where TP denotes the number of True Positives (both VFR and FFR positive) and FN denotes the number of False Negatives (VFR negative but FFR positive). Specificity is defined as the percentage of VFR negative lesions in the group of FFR negative lesions. Specificity=TN/(TN+FP) x 100%, where TN denotes the number of True Negatives (both VFR and FFR negatives) and FP denotes the number of False Positives (VFR positive but FFR negative).

  Baseline (pre-procedure) and immediately post-procedure

Secondary Outcomes (4)

• Overall Diagnostic Accuracy

  Baseline (pre-procedure) and immediately post-procedure

• Positive Predictive Value (PPV) and Negative Predictive Value (NPV)

  Baseline (pre-procedure) and immediately post-procedure

• Correlation Between VFR and FFR

  Baseline (pre-procedure) and immediately post-procedure (post-procedure)

• Area Under Curve (AUC) Against FFR

  Baseline (pre-procedure) and immediately post-procedure (post-procedure)

Study Arms (1)

Standard of Care: Angiography, OCT, FFR, and VFR

Patients will have Pre-OCT Angiography, OCT pullbacks, a FFR measurement and a VFR analysis

Procedure: ICA (Invasive Coronary Angiography); Procedure: OCT; Procedure: FFR; Other: VFR Analysis

Interventions

ICA (Invasive Coronary Angiography) PROCEDURE

Patients will undergo a Pre-PCI Angiography

Standard of Care: Angiography, OCT, FFR, and VFR

OCT PROCEDURE

OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure

Standard of Care: Angiography, OCT, FFR, and VFR

FFR PROCEDURE

FFR will be measured

Standard of Care: Angiography, OCT, FFR, and VFR

VFR Analysis OTHER

VFR will be calculated offline using the OCT pullback images

Standard of Care: Angiography, OCT, FFR, and VFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This clinical investigation will enroll male and female subjects from the general interventional cardiology population.

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (28)

Heart Center Research, LLC.

Huntsville, Alabama, 35801, United States

Location

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

VA Palo Alto Medical Center

Palo Alto, California, 94604, United States

Location

UCLA Medical Center Santa Monica

Santa Monica, California, 90404, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

The Cardiac & Vascular Institute Research Foundation, LLC

Gainesville, Florida, 32605, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67214-3882, United States

Location

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

St. Patrick Hospital

Missoula, Montana, 59802, United States

Location

New York University Hospital

New York, New York, 10016, United States

Location

New York-Presbyterian/Columbia University Medical Center

New York, New York, 10032, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Montefiore Medical Center - Moses Division

The Bronx, New York, 10467, United States

Location

VA Medical Center Durham

Durham, North Carolina, 27705, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Holy Spirit Hospital

Camp Hill, Pennsylvania, 17011, United States

Location

Greenville Health System

Greenville, South Carolina, 29605-5601, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

University of Texas Medical Branch (UTMB)

Galveston, Texas, 77555-0144, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Jeremias A, Maehara A, Matsumura M, Shlofmitz RA, Maksoud A, Akasaka T, Bezerra HG, Fearon WF, Samady H, Samuels B, Rapkin J, Gopinath A, Teraphongphom NT, Buccola J, Ali ZA. Optical Coherence Tomography-Based Functional Stenosis Assessment: FUSION-A Prospective Multicenter Trial. Circ Cardiovasc Interv. 2024 Apr;17(4):e013702. doi: 10.1161/CIRCINTERVENTIONS.123.013702. Epub 2024 Mar 25.

  PMID: 38525609 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Tarn Teraphongphom, Principal Clinical Research Scientist
• Organization: Abbott

tarn.teraphongphom@abbott.com

+1 (408) 931-0504

Study Officials

• Allen Jeremias, MD

  St. Francis Hospital,Roslyn,NY, United States

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 21, 2020
• Study Start: June 26, 2020
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)