Clinical trial NCT04356027: FUnctional diagnoSIs of corONary Stenosis (FUSION)
Official title: Validation of OCT-based FUnctional diagnoSIs of corONary Stenosis (FUSION)
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2020-04-21
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This clinical investigation will enroll male and female subjects from the general interventional cardiology population.

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).

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 criteria: 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

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
* Participation in another clinical study of an investigational drug or device
* Presence of aneurysm in the target vessel

Imaging and Pressure Tracing Exclusion Criteria:

* Artifact in pre-PCI OCT for the target lesion or in the event of multiple target lesions, artifact in pre-PCI OCT for ALL target lesions
* Target lesion requires any preparation (including but not limited to balloon dilatation, atherectomy, etc.) prior to pre-PCI OCT and physiology measurement, or in case of multiple target lesions, ALL target lesions require-any preparation (including but not limited to balloon dilatation, atherectomy, etc.) prior to pre-PCI OCT and physiology measurement
* Severe vessel tortuosity or calcification in the target vessel such that it is unlikely that the OCT catheter can be delivered
* Target lesion not imaged by OCT or in the event of multiple target lesions, ALL target lesions not imaged by OCT
* Pressure drift of \> 0.03; i.e. Pd and Pa ratio value \< 0.97 or \> 1.03, unless physiology measurements are repeated after re-equalization
* Target lesion or significant CAD beyond 60mm from coronary ostium; i.e. not able to clearly image and capture all disease segment with OCT in 1 run
* Incorrectly done or unsuccessful catheter purge and/or contrast flush
* Presence of plaque rupture and/or intravascular hematoma in target vessel (visual % diameter stenosis ≥ 40%)
* Inability to receive intracoronary nitroglycerin prior to OCT or FFR
* Use of flush media other than radiographic contrast

Primary outcomes:
measure: Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR)
timeFrame: Baseline (pre-procedure) and immediately post-procedure
Secondary outcomes:
measure: Overall Diagnostic Accuracy
timeFrame: Baseline (pre-procedure) and immediately post-procedure
measure: Positive Predictive Value (PPV) and Negative Predictive Value (NPV)
timeFrame: Baseline (pre-procedure) and immediately post-procedure
measure: Correlation Between VFR and FFR
timeFrame: Baseline (pre-procedure) and immediately post-procedure (post-procedure)
measure: Area Under Curve (AUC) Against FFR
timeFrame: Baseline (pre-procedure) and immediately post-procedure (post-procedure)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC.
state: Alabama
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Palo Alto
country: United States
facility: VA Palo Alto Medical Center
state: California
city: Santa Monica
country: United States
facility: UCLA Medical Center Santa Monica
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Gainesville
country: United States
facility: The Cardiac & Vascular Institute Research Foundation, LLC
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Wichita
country: United States
facility: Via Christi Regional Medical Center - St. Francis Campus
state: Kansas
city: Wichita
country: United States
facility: Cardiovascular Research Institute of Kansas
state: Kansas
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Missoula
country: United States
facility: St. Patrick Hospital
state: Montana
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Division
state: New York
city: New York
country: United States
facility: New York University Hospital
state: New York
city: New York
country: United States
facility: New York-Presbyterian/Columbia University Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Durham
country: United States
facility: VA Medical Center Durham
state: North Carolina
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Camp Hill
country: United States
facility: Holy Spirit Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch (UTMB)
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: St. Francis Hospital,Roslyn,NY, United States
name: Allen Jeremias, MD
role: PRINCIPAL_INVESTIGATOR
References: