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).
Brief Title
FUnctional diagnoSIs of corONary Stenosis (FUSION)
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Coronary Artery Disease
Coronary Stenosis
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Virtual Flow Reserve (VFR)
Optical Coherence Tomography (OCT)
Fractional Flow Reserve (FFR)
Percutaneous Coronary Intervention (PCI)
OPTIS System
Dragonfly
PressureWire X
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04356027
Org Class
Industry
Org Full Name
Abbott Medical Devices
Org Study Id
ABT-CIP-10331
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Validation of OCT-based FUnctional diagnoSIs of corONary Stenosis (FUSION)
Primary Outcomes
Outcome Description
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).
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).
Outcome Measure
Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR)
Outcome Time Frame
Baseline (pre-procedure) and immediately post-procedure
Secondary Outcomes
Outcome Description
Overall diagnostic accuracy is defined as the proportion of correctly classified lesions among all lesions.
Overall Diagnostic Accuracy= (TP+TN)/(TP+TN+FP+FN) x 100%, 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.
Overall Diagnostic Accuracy= (TP+TN)/(TP+TN+FP+FN) x 100%, 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.
Outcome Time Frame
Baseline (pre-procedure) and immediately post-procedure
Outcome Measure
Overall Diagnostic Accuracy
Outcome Description
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) x 100%, where TP denotes the number of True Positives and FP denotes the number of False Positives.
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) x 100%, where TN denotes the number of True Negatives and FN denotes the number of False Negatives.
PPV= TP/(TP+FP) x 100%, where TP denotes the number of True Positives and FP denotes the number of False Positives.
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) x 100%, where TN denotes the number of True Negatives and FN denotes the number of False Negatives.
Outcome Time Frame
Baseline (pre-procedure) and immediately post-procedure
Outcome Measure
Positive Predictive Value (PPV) and Negative Predictive Value (NPV)
Outcome Description
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.
Outcome Time Frame
Baseline (pre-procedure) and immediately post-procedure (post-procedure)
Outcome Measure
Correlation Between VFR and FFR
Outcome Description
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.
Outcome Time Frame
Baseline (pre-procedure) and immediately post-procedure (post-procedure)
Outcome Measure
Area Under Curve (AUC) Against FFR
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
This clinical investigation will enroll male and female subjects from the general interventional cardiology population.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Judah Rauch
Investigator Email
jrauch@montefiore.org
Investigator Phone
646-668-6437
Categories Mesh Debug
Blood Disorders --- CORONARY ARTERY DISEASE
Heart/Cardiovascular --- CORONARY ARTERY DISEASE
Heart/Cardiovascular --- MYOCARDIAL ISCHEMIA
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- ARTERIOSCLEROSIS
Heart/Cardiovascular --- ARTERIAL OCCLUSIVE DISEASES
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
MeSH Terms
CORONARY ARTERY DISEASE
CORONARY STENOSIS
CORONARY DISEASE
MYOCARDIAL ISCHEMIA
HEART DISEASES
CARDIOVASCULAR DISEASES
ARTERIOSCLEROSIS
ARTERIAL OCCLUSIVE DISEASES
VASCULAR DISEASES