Clincosm LogoSign in Get a demo

FUnctional diagnoSIs of corONary Stenosis (FUSION)

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT04356027
Collaborator
(none)
312
Enrollment
28
Locations
15.6
Actual Duration (Months)
11.1
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: ICA (Invasive Coronary Angiography)
  • Procedure: OCT
  • Procedure: FFR
  • Other: VFR Analysis

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.

Study Design

Study Type:
Observational
Actual Enrollment :
312 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Validation of OCT-based FUnctional diagnoSIs of corONary Stenosis (FUSION)
Actual Study Start Date :
Jun 26, 2020
Actual Primary Completion Date :
Oct 15, 2021
Actual Study Completion Date :
Oct 15, 2021

Arms and Interventions

Arm Intervention/Treatment
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)
Patients will undergo a Pre-PCI Angiography

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

Procedure: FFR
FFR will be measured

Other: VFR Analysis
VFR will be calculated offline using the OCT pullback images

Outcome Measures

Primary Outcome Measures

  1. Sensitivity and specificity of Virtual Flow Reserve (VFR) against Fractional Flow Reserve (FFR) [1 hour]

    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 proportion of VFR positive lesions, in the group of FFR positive lesions. Sensitivity=TP/(TP+FN), 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 proportion of VFR negative lesions in the group of FFR negative lesions. Specificity=TN/(TN+FP), 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).

Secondary Outcome Measures

  1. Overall diagnostic accuracy [1 hour]

    Overall diagnostic accuracy is defined as the proportion of correctly classified lesions among all lesions. Overall Diagnostic Accuracy= (TP+TN)/(TP+TN+FP+FN), where TP denotes the number of True Positives, FN denotes the number of False Negatives, TN denotes the number of True Negatives, and FN denotes the number of False Negatives.

  2. Positive predictive value (PPV) [1 hour]

    PPV is defined as the proportion of lesions with the disease and with a positive test result among the group of lesions with a positive test result. PPV= TP/(TP+FP), where TP denotes the number of True Positives and FP denotes the number of False Positives.

  3. Negative predictive value (NPV) [1 hour]

    NPV is defined as the proportion of lesions without the disease and with a negative test result among the group of lesions with negative test results. NPV= TN/(TN+FN), where TN denotes the number of True Negatives and FN denotes the number of False Negatives.

  4. Correlation between VFR and FFR [1 hour]

    The correlation between VFR and FFR will be estimated as the R^2 correlation coefficient from the simple linear regression model using VFR value as the independent variable and FFR as the dependent variable.

  5. Area under curve (AUC) against FFR [1 hour]

    AUC will be estimated as the area under the ROC curve. ROC curve will be constructed using specificity on the x-axis and sensitivity on the y-axis. Sensitivity and specificity are calculated at various values of VFR and FFR, and the AUC curve will be drawn using logistic regression.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Heart Center Research, LLC. Huntsville Alabama United States 35801
2 HonorHealth Scottsdale Arizona United States 85258
3 Arkansas Heart Hospital Little Rock Arkansas United States 72211
4 VA Palo Alto Medical Center Palo Alto California United States 94604
5 UCLA Medical Center Santa Monica Santa Monica California United States 90404
6 Holy Cross Hospital Fort Lauderdale Florida United States 33308
7 The Cardiac & Vascular Institute Research Foundation, LLC Gainesville Florida United States 32605
8 Tampa General Hospital Tampa Florida United States 33606
9 Atlanta VA Medical Center Decatur Georgia United States 30033
10 Loyola University Medical Center Maywood Illinois United States 60153
11 Via Christi Regional Medical Center - St. Francis Campus Wichita Kansas United States 67214-3882
12 Cardiovascular Research Institute of Kansas Wichita Kansas United States 67226
13 Brigham & Women's Hospital Boston Massachusetts United States 02115
14 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
15 Mercy Hospital Coon Rapids Minnesota United States 55433
16 St. Patrick Hospital Missoula Montana United States 59802
17 Montefiore Medical Center - Moses Division Bronx New York United States 10467
18 New York University Hospital New York New York United States 10016
19 New York-Presbyterian/Columbia University Medical Center New York New York United States 10032
20 St. Francis Hospital Roslyn New York United States 11576
21 VA Medical Center Durham Durham North Carolina United States 27705
22 Providence St. Vincent Medical Center Portland Oregon United States 97225
23 Holy Spirit Hospital Camp Hill Pennsylvania United States 17011
24 Greenville Health System Greenville South Carolina United States 29605-5601
25 Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
26 Austin Heart Austin Texas United States 78756
27 University of Texas Medical Branch (UTMB) Galveston Texas United States 77555-0144
28 Memorial Hermann Hospital Houston Texas United States 77030

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

  • Principal Investigator: Allen Jeremias, MD, St. Francis Hospital,Roslyn,NY, United States

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT04356027
Other Study ID Numbers:
  • ABT-CIP-10331
First Posted:
Apr 21, 2020
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Abbott Medical Devices
Virtual Flow Reserve (VFR)
Optical Coherence Tomography (OCT)
Fractional Flow Reserve (FFR)
Percutaneous Coronary Intervention (PCI)
OPTIS System
Dragonfly
PressureWire X
Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Stenosis
Constriction, Pathologic

Study Results

No Results Posted as of Jun 22, 2022