Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.

• Sponsor: State University of New York at Buffalo (Other)
• Overall Status: Completed
• CT.gov ID: NCT03149042
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Actual Duration (Months): 34.8
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT estimation can aid in the severity estimation of significant atherosclerotic lesions. Currently, FFR-CT algorithms can only be optimized using theoretical models and can only be validated in large multi-center clinical trials. Using patient specific 3D printed coronary phantoms would allow optimization of FFR-CT algorithms with a measured validation technique without the need for large clinical trials. Thus the investigators believe that this study will result in a FFR-CT algorithm/method with a better predictability for arterial lesion severity than those existing on the market today. Flow measurements will be compared with: CT-FFR for both patients and phantoms, angio lab FFR measurements and 30 days follow-up. This pilot clinical study includes ~50 patients over a year and half at GVI.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis, Coronary	Diagnostic Test: CCTA

Detailed Description

Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT estimation can aid in the severity estimation of significant atherosclerotic lesions. Following this trend, the investigators recently developed a collaboration between Brigham and Women's Hospital (BWH) and Gates Vascular Institute (GVI). The investigators 3D-printed patient specific coronary phantoms at (GVI) and scanned them with a Toshiba Aquilion scanner to test several aspects of the contrast opacification gradients using a method established at BWH. The initial results showed strong correlation between the flow in the phantom and opacification gradients. The investigators believe that this approach could be further developed to test and validate FFR-CT algorithms. Currently, FFR-CT algorithms can only be optimized using theoretical models and can only be validated in large multi-center clinical trials. This phantom approach would allow optimization of FFR-CT algorithms with a measured validation technique without the need for large clinical trials. Thus the investigators believe that this study will result in a FFR-CT algorithm/method with a better predictability for arterial lesion severity than those existing on the market today. The approach is to use the infrastructure at GVI to perform a detailed validation of the FFR-CT method using 3D printed patient specific phantoms. The subject enrollment criteria is: at least one CCTA, at least one lesion with >50% stenosis or 30-50% and an angio based FFR. Each patient will have a 3D phantom printed, containing the culprit lesion and used in a benchtop flow analysis. Flow measurements will be compared with: CT-FFR for both patients and phantoms, angio lab FFR measurements and 30 days follow-up. This pilot clinical study will include ~50 patients over a year and half at GVI. The investigators are confident that this approach performed via 3D-phantom testing will prove the validity of FFR-CT based measurements as well as develop a new standard for validating FFR-CT algorithms.

Study Design

• Study Type: Observational
• Actual Enrollment: 75 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.
• Actual Study Start Date: May 28, 2016
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Apr 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
CCTA Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital.	Diagnostic Test: CCTA; Diagnostic Test

Outcome Measures

Primary Outcome Measures

1. Comparison of CT Based FFR With Invasive FFR, ROC Analysis [24 hours]

   Patient CCTA images were imported into Vitrea segmentation software (Vital Images, Minnetonka, MN) for use in the research-based CT based FFR algorithm. The software analyzes four data volumes acquired a 70%, 80%, 90% and 99% of the R-R interval and computes the FFR based on the changes in vessel diameter and computational fluid dynamics. Within the algorithm, the aortic root and three main coronary arteries (LAD, LCX, and RCA) were automatically segmented, and then manually adjusted to obtain accurate centerline and contours. The CT based FFR was calculated and the user adjusted the location of the distal pressure measurement to calculate the CT basedFFR at the same location as Invasive-FFR, two lesion lengths below the distal end of the lesion. Area under the Receiver Operator Characteristic were measured where an Invasive FFR<=0.8 was considered positive.

2. Comparison of CT Based FFR With Invasive FFR, Correlation Analysis [24 hours]

   Patient CCTA images were imported into Vitrea segmentation software (Vital Images, Minnetonka, MN) for use in the research-based CT based FFR algorithm. The software analyzes four data volumes acquired a 70%, 80%, 90% and 99% of the R-R interval and computes the FFR based on the changes in vessel diameter and computational fluid dynamics. Within the algorithm, the aortic root and three main coronary arteries (LAD, LCX, and RCA) were automatically segmented, and then manually adjusted to obtain accurate centerline and contours. The CT based FFR was calculated and the user adjusted the location of the distal pressure measurement to calculate the CT basedFFR at the same location as Invasive-FFR, two lesion lengths below the distal end of the lesion. Pearson Correlation between Invasive FFR and CT based FFR was measured

3. Comparison of CT Based FFR With Invasive FFR, Sensitivity [24 hours]

   Patient CCTA images were imported into Vitrea segmentation software (Vital Images, Minnetonka, MN) for use in the research-based CT based FFR algorithm. The software analyzes four data volumes acquired a 70%, 80%, 90% and 99% of the R-R interval and computes the FFR based on the changes in vessel diameter and computational fluid dynamics. Within the algorithm, the aortic root and three main coronary arteries (LAD, LCX, and RCA) were automatically segmented, and then manually adjusted to obtain accurate centerline and contours. The CT based FFR was calculated and the user adjusted the location of the distal pressure measurement to calculate the CT basedFFR at the same location as Invasive-FFR, two lesion lengths below the distal end of the lesion. Sensitivity were measured where an Invasive FFR<=0.8 was considered positive. Sensitivity reflects the percentage of true positive cases identified by CT-FFR compared to I-FFR

4. Comparison of CT Based FFR With Invasive FFR, Specificity [24 hours]

   Patient CCTA images were imported into Vitrea segmentation software (Vital Images, Minnetonka, MN) for use in the research-based CT based FFR algorithm. The software analyzes four data volumes acquired a 70%, 80%, 90% and 99% of the R-R interval and computes the FFR based on the changes in vessel diameter and computational fluid dynamics. Within the algorithm, the aortic root and three main coronary arteries (LAD, LCX, and RCA) were automatically segmented, and then manually adjusted to obtain accurate centerline and contours. The CT based FFR was calculated and the user adjusted the location of the distal pressure measurement to calculate the CT basedFFR at the same location as Invasive-FFR, two lesion lengths below the distal end of the lesion. Specificity was measured, where an Invasive FFR<=0.8 was considered positive. Specificity reflects the percentage of true negative cases identified by CT-FFR compared to I-FFR

Secondary Outcome Measures

1. Comparison of CT Based FFR With Bench-top FFR Using 3D Printed Patient Specific Phantoms [4 weeks from baseline]

   CT images were used to measure CT-FFR and to generate patient-specific 3D printed models of the aortic root and three main coronary arteries. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and bench-top FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Linear regression and Pearson correlation was calculated.

2. Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, ROC Analysis [4 weeks from baseline]

   CT images were used to create patient specific 3d-printed phantom. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and benchtop FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Benchtop-FFR was compared with Invasive-FFR. Area under the Receiver Operator Characteristic were measured where an Invasive FFR<=0.8 was considered positive.

3. Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, Pearson Correlation [4 weeks from baseline]

   CT images were used to create patient specific 3d-printed phantom. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and benchtop FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Benchtop-FFR was compared with Invasive-FFR. Pearson Correlation factor was calculated.

4. Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, Sensitivity [4 weeks from baseline]

   CT images were used to create patient specific 3d-printed phantom. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and benchtop FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Benchtop-FFR was compared with Invasive-FFR. Sensitivity was measure, where an Invasive FFR<=0.8 was considered positive.Sensitivity reflects the percentage of true positive cases identified by B-FFR compared to I-FFR

5. Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, Specificity [4 weeks from baseline]

   CT images were used to create patient specific 3d-printed phantom. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and benchtop FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Benchtop-FFR was compared with Invasive-FFR. Specificity was calculated, where an Invasive FFR<=0.8 was considered positive. Specificity reflects the percentage of true negative cases identified by B-FFR compared to I-FFR

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• All the patients >18 yrs of age , who are undergoing CCTA and angio-FFR. Patients who are (1) scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital or (2) clinically mandated CTA will be screened.

Exclusion Criteria:

• Adults unable to consent

• Individuals who are not yet adults (infants, children, teenagers)

• Pregnant women

• Prisoners

• atrial fibrillation,

• Renal insufficiency (estimated glomerular filtration rate (GFR) <60 ml/min/1.73 m2),

• Active Bronchospasm prohibiting the use of beta blockers

• Morbid obesity (body mass index 40 kg/m2)

• Contraindications to iodinated contrast.

• Emergencies requiring immediate intervention or patients unable to consent.

• Patients not showing coronary calcium during Calcium Scoring procedures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical and Translational Research Center Room 8052	Buffalo	New York	United States	14021

Sponsors and Collaborators

• State University of New York at Buffalo

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Jan 15, 2019
• Study Protocol and Statistical Analysis Plan - Sep 24, 2019

More Information

Additional Information:

• results

Publications

• Ionita, C., Angel, E., Mitsouras, D., Rudin, S., Bednarek, D., Zaid, S., Wilson, M. and Rybicki, F. (2016), TU-H-CAMPUS-IeP2-03: Development of 3D Printed Coronary Phantoms for In-Vitro CT-FFR Validation Using Data from 320- Detector Row Coronary CT Angiography. Med. Phys., 43: 3781. doi:10.1118/1.4957681
• Kelsey N. Sommer, Lauren M. Shepard, Vijay Iyer, Erin Angel, Michael F. Wilson, Frank J. Rybicki, Dimitrios Mitsouras, Ciprian Ionita. Study of the effect of boundary conditions on fractional flow reserve using patient specific coronary phantoms. Proceedings Volume 11317, Medical Imaging 2020: Biomedical Applications in Molecular, Structural, and Functional Imaging; 113171J (2020) https://doi.org/10.1117/12.2548472
• Kelsey N. Sommer, Lauren M. Shepard, Vijay Iyer, Erin Angel, Michael F. Wilson, Frank J. Rybicki, Dimitrios Mitsouras, Kanako Kunishima Kumamaru, Stephen Rudin, and Ciprian N. Ionita. Comparison of benchtop pressure gradient measurements in 3D printed patient specific cardiac phantoms with CT-FFR and computational fluid dynamic simulations, Proc. SPIE 10953, Medical Imaging 2019: Biomedical Applications in Molecular, Structural, and Functional Imaging, 109531P (15 March 2019);
• Shepard L, Sommer K, Izzo R, Podgorsak A, Wilson M, Said Z, Rybicki FJ, Mitsouras D, Rudin S, Angel E, Ionita CN. Initial Simulated FFR Investigation Using Flow Measurements in Patient-specific 3D Printed Coronary Phantoms. Proc SPIE Int Soc Opt Eng. 2017 Feb 11;10138. pii: 101380S. doi: 10.1117/12.2253889. Epub 2017 Mar 13.
• Shepard LM, Sommer KN, Angel E, Iyer V, Wilson MF, Rybicki FJ, Mitsouras D, Molloi S, Ionita CN. Initial evaluation of three-dimensionally printed patient-specific coronary phantoms for CT-FFR software validation. J Med Imaging (Bellingham). 2019 Apr;6(2):021603. doi: 10.1117/1.JMI.6.2.021603. Epub 2019 Mar 12.
• Sommer K, Izzo RL, Shepard L, Podgorsak AR, Rudin S, Siddiqui AH, Wilson MF, Angel E, Said Z, Springer M, Ionita CN. Design Optimization for Accurate Flow Simulations in 3D Printed Vascular Phantoms Derived from Computed Tomography Angiography. Proc SPIE Int Soc Opt Eng. 2017 Feb 11;10138. pii: 101380R. doi: 10.1117/12.2253711. Epub 2017 Mar 13.
• Sommer KN, Shepard L, Karkhanis NV, Iyer V, Angel E, Wilson MF, Rybicki FJ, Mitsouras D, Rudin S, Ionita CN. 3D Printed Cardiovascular Patient Specific Phantoms Used for Clinical Validation of a CT-derived FFR Diagnostic Software. Proc SPIE Int Soc Opt Eng. 2018 Feb;10578. pii: 105780J. doi: 10.1117/12.2292736. Epub 2018 Mar 12.

• Responsible Party: Ciprian Ionita, Principal Investigator, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT03149042
• Other Study ID Numbers: 01
• First Posted: May 11, 2017
• Last Update Posted: Nov 17, 2020
• Last Verified: Nov 1, 2020

• 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 Ciprian Ionita, Principal Investigator, State University of New York at Buffalo: FFR; Fractional Flow Reserve; Atherosclerosis; Coronary; stenosis
• Additional relevant MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia

Study Results

Participant Flow

Arm/Group Title	CCTA
Arm/Group Description	Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital. CCTA (Coronary CT angiography) Diagnostic Test
Period Title: Overall Study
STARTED	75
COMPLETED	52
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	CCTA
Arm/Group Description	Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital. CCTA Coronary: Diagnostic Test
Overall Participants	52
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	22 42.3%
>=65 years	30 57.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.7 (10.4)
Sex: Female, Male (Count of Participants)
Female	20 38.5%
Male	32 61.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	0 0%
Unknown or Not Reported	52 100%
Region of Enrollment (Count of Participants)
United States	17 32.7%
Japan	35 67.3%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.2 (3.9)
Coronary Calcium Score (Coronary Calcium Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Coronary Calcium Score]	385 (388)
FFR (Count of Participants)
FFR>0.8	29 55.8%
FFR<=0.8	23 44.2%
Diabetes Mellitus (Count of Participants)
Yes	22 42.3%
No	30 57.7%
Hypertension (Count of Participants)
Yes	33 63.5%
No	19 36.5%
Hyperlipidemia (Count of Participants)
Yes	38 73.1%
No	14 26.9%
Smoking (Count of Participants)
Former	16 30.8%
Current	10 19.2%
Never	26 50%
Prior Myocardial Infarction (Count of Participants)
Yes	4 7.7%
No	48 92.3%
Creatinine (mg/ dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/ dl]	0.83 (0.45)

Outcome Measures

1. Primary Outcome

Title	Comparison of CT Based FFR With Invasive FFR, ROC Analysis
Description	Patient CCTA images were imported into Vitrea segmentation software (Vital Images, Minnetonka, MN) for use in the research-based CT based FFR algorithm. The software analyzes four data volumes acquired a 70%, 80%, 90% and 99% of the R-R interval and computes the FFR based on the changes in vessel diameter and computational fluid dynamics. Within the algorithm, the aortic root and three main coronary arteries (LAD, LCX, and RCA) were automatically segmented, and then manually adjusted to obtain accurate centerline and contours. The CT based FFR was calculated and the user adjusted the location of the distal pressure measurement to calculate the CT basedFFR at the same location as Invasive-FFR, two lesion lengths below the distal end of the lesion. Area under the Receiver Operator Characteristic were measured where an Invasive FFR<=0.8 was considered positive.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

From the total number of patients, nine patients had multi-vessel disease and I-FFR was measured in two vessels. In total I-FFR was measured in: 42 LADs, 11 LCXs and 8 RCAs. Invasive -FFR measurement location was from the ostium to two lesion lengths below the distal throat of the lesion .

Arm/Group Title	CCTA
Arm/Group Description	Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital. CCTA Coronary: Diagnostic Test
Measure Participants	52
Measure Coronary Arteries	61
Number (95% Confidence Interval) [probability of accurate diagnosis]	0.8

2. Primary Outcome

Title	Comparison of CT Based FFR With Invasive FFR, Correlation Analysis
Description	Patient CCTA images were imported into Vitrea segmentation software (Vital Images, Minnetonka, MN) for use in the research-based CT based FFR algorithm. The software analyzes four data volumes acquired a 70%, 80%, 90% and 99% of the R-R interval and computes the FFR based on the changes in vessel diameter and computational fluid dynamics. Within the algorithm, the aortic root and three main coronary arteries (LAD, LCX, and RCA) were automatically segmented, and then manually adjusted to obtain accurate centerline and contours. The CT based FFR was calculated and the user adjusted the location of the distal pressure measurement to calculate the CT basedFFR at the same location as Invasive-FFR, two lesion lengths below the distal end of the lesion. Pearson Correlation between Invasive FFR and CT based FFR was measured
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

From the total number of patients, nine patients had multi-vessel disease and I-FFR was measured in two vessels. In total I-FFR was measured in: 42 LADs, 11 LCXs and 8 RCAs. Invasive -FFR measurement location was from the ostium to two lesion lengths below the distal throat of the lesion .

Arm/Group Title	CCTA
Arm/Group Description	Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital. CCTA Coronary: Diagnostic Test
Measure Participants	75
Measure Coronary Arteries	61
Number (95% Confidence Interval) [correlation coefficient]	0.75

3. Primary Outcome

Title	Comparison of CT Based FFR With Invasive FFR, Sensitivity
Description	Patient CCTA images were imported into Vitrea segmentation software (Vital Images, Minnetonka, MN) for use in the research-based CT based FFR algorithm. The software analyzes four data volumes acquired a 70%, 80%, 90% and 99% of the R-R interval and computes the FFR based on the changes in vessel diameter and computational fluid dynamics. Within the algorithm, the aortic root and three main coronary arteries (LAD, LCX, and RCA) were automatically segmented, and then manually adjusted to obtain accurate centerline and contours. The CT based FFR was calculated and the user adjusted the location of the distal pressure measurement to calculate the CT basedFFR at the same location as Invasive-FFR, two lesion lengths below the distal end of the lesion. Sensitivity were measured where an Invasive FFR<=0.8 was considered positive. Sensitivity reflects the percentage of true positive cases identified by CT-FFR compared to I-FFR
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

From the total number of patients, nine patients had multi-vessel disease and I-FFR was measured in two vessels. In total I-FFR was measured in: 42 LADs, 11 LCXs and 8 RCAs. Invasive -FFR measurement location was from the ostium to two lesion lengths below the distal throat of the lesion .

Arm/Group Title	CCTA
Arm/Group Description	Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital. CCTA : Diagnostic Test
Measure Participants	52
Measure Coronary Arteries	61
Number [percentage of true positive cases]	82.61

4. Primary Outcome

Title	Comparison of CT Based FFR With Invasive FFR, Specificity
Description	Patient CCTA images were imported into Vitrea segmentation software (Vital Images, Minnetonka, MN) for use in the research-based CT based FFR algorithm. The software analyzes four data volumes acquired a 70%, 80%, 90% and 99% of the R-R interval and computes the FFR based on the changes in vessel diameter and computational fluid dynamics. Within the algorithm, the aortic root and three main coronary arteries (LAD, LCX, and RCA) were automatically segmented, and then manually adjusted to obtain accurate centerline and contours. The CT based FFR was calculated and the user adjusted the location of the distal pressure measurement to calculate the CT basedFFR at the same location as Invasive-FFR, two lesion lengths below the distal end of the lesion. Specificity was measured, where an Invasive FFR<=0.8 was considered positive. Specificity reflects the percentage of true negative cases identified by CT-FFR compared to I-FFR
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

From the total number of patients, nine patients had multi-vessel disease and I-FFR was measured in two vessels. In total I-FFR was measured in: 42 LADs, 11 LCXs and 8 RCAs. Invasive -FFR measurement location was from the ostium to two lesion lengths below the distal throat of the lesion .

Arm/Group Title	CCTA
Arm/Group Description	Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital. CCTA : Diagnostic Test
Measure Participants	52
Measure Coronary Arteries	61
Number [percentage of of true negative cases]	76.32

5. Secondary Outcome

Title	Comparison of CT Based FFR With Bench-top FFR Using 3D Printed Patient Specific Phantoms
Description	CT images were used to measure CT-FFR and to generate patient-specific 3D printed models of the aortic root and three main coronary arteries. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and bench-top FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Linear regression and Pearson correlation was calculated.
Time Frame	4 weeks from baseline

Outcome Measure Data

Analysis Population Description

From the total number of patients, nine patients had multi-vessel disease and Invasive-FFR was measured in two vessels. In total I-FFR was measured in: 42 LADs, 11 LCXs and 8 RCAs. Bench-top FFR was measured at the same locations as Invasive -FFR, from the ostium to two lesion lengths below the distal throat of the lesion .

Arm/Group Title	CCTA
Arm/Group Description	Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital. CCTA : Diagnostic Test
Measure Participants	52
Measure Coronary Arteries	61
Number (95% Confidence Interval) [correlation coefficient]	0.64

6. Secondary Outcome

Title	Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, ROC Analysis
Description	CT images were used to create patient specific 3d-printed phantom. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and benchtop FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Benchtop-FFR was compared with Invasive-FFR. Area under the Receiver Operator Characteristic were measured where an Invasive FFR<=0.8 was considered positive.
Time Frame	4 weeks from baseline

Outcome Measure Data

Analysis Population Description

From the total number of patients, nine patients had multi-vessel disease and Invasive-FFR was measured in two vessels. In total I-FFR was measured in: 42 LADs, 11 LCXs and 8 RCAs. Bench-top FFR was measured at the same locations as Invasive -FFR, from the ostium to two lesion lengths below the distal throat of the lesion .

Arm/Group Title	CCTA
Arm/Group Description	Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital. CCTA : Diagnostic Test
Measure Participants	52
Measure Coronary Arteries	61
Number (95% Confidence Interval) [probability of accurate diagnosis]	0.81

7. Secondary Outcome

Title	Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, Pearson Correlation
Description	CT images were used to create patient specific 3d-printed phantom. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and benchtop FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Benchtop-FFR was compared with Invasive-FFR. Pearson Correlation factor was calculated.
Time Frame	4 weeks from baseline

Outcome Measure Data

Analysis Population Description

From the total number of patients, nine patients had multi-vessel disease and Invasive-FFR was measured in two vessels. In total I-FFR was measured in: 42 LADs, 11 LCXs and 8 RCAs. Bench-top FFR was measured at the same locations as Invasive -FFR, from the ostium to two lesion lengths below the distal throat of the lesion .

Arm/Group Title	CCTA
Arm/Group Description	Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital. CCTA : Diagnostic Test
Measure Participants	52
Measure Coronary Arteries	61
Number (95% Confidence Interval) [correlation coefficient]	0.71

8. Secondary Outcome

Title	Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, Sensitivity
Description	CT images were used to create patient specific 3d-printed phantom. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and benchtop FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Benchtop-FFR was compared with Invasive-FFR. Sensitivity was measure, where an Invasive FFR<=0.8 was considered positive.Sensitivity reflects the percentage of true positive cases identified by B-FFR compared to I-FFR
Time Frame	4 weeks from baseline

Outcome Measure Data

Analysis Population Description

From the total number of patients, nine patients had multi-vessel disease and Invasive-FFR was measured in two vessels. In total I-FFR was measured in: 42 LADs, 11 LCXs and 8 RCAs. Bench-top FFR was measured at the same locations as Invasive -FFR, from the ostium to two lesion lengths below the distal throat of the lesion .

Arm/Group Title	CCTA
Arm/Group Description	Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital. CCTA : Diagnostic Test
Measure Participants	52
Measure Coronary Arteries	61
Number [percentage of true positive cases]	86.96

9. Secondary Outcome

Title	Comparison of Bench-top FFR Using 3D Printed Patient Specific Phantoms With Invasive FFR, Specificity
Description	CT images were used to create patient specific 3d-printed phantom. Each patient-specific 3D printed model was connected to a programmable pulsatile pump and benchtop FFR (B-FFR) was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. B-FFR was measured for hyperemic", 500 mL/min by adjusting the model's distal coronary resistance. Benchtop-FFR was compared with Invasive-FFR. Specificity was calculated, where an Invasive FFR<=0.8 was considered positive. Specificity reflects the percentage of true negative cases identified by B-FFR compared to I-FFR
Time Frame	4 weeks from baseline

Outcome Measure Data

Analysis Population Description

From the total number of patients, nine patients had multi-vessel disease and Invasive-FFR was measured in two vessels. In total I-FFR was measured in: 42 LADs, 11 LCXs and 8 RCAs. Bench-top FFR was measured at the same locations as Invasive -FFR, from the ostium to two lesion lengths below the distal throat of the lesion .

Arm/Group Title	CCTA
Arm/Group Description	Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital. CCTA : Diagnostic Test
Measure Participants	52
Measure Coronary Arteries	61
Number [percentage of true negative cases]	97.37

Adverse Events

Time Frame	The participant was observed for 24 hours post CCTA acquisition.
Adverse Event Reporting Description	No risk of serious adverse events, mortality, or other adverse events during CCTA scan.
Arm/Group Title	CCTA Coronary
Arm/Group Description	Patients who are scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital and Juntendo University, Japan. CCTA Coronary: Diagnostic Test
All Cause Mortality
	CCTA Coronary
	Affected / at Risk (%)	# Events
Total	0/52 (0%)
Serious Adverse Events
	CCTA Coronary
	Affected / at Risk (%)	# Events
Total	0/52 (0%)
Other (Not Including Serious) Adverse Events
	CCTA Coronary
	Affected / at Risk (%)	# Events
Total	0/52 (0%)

Limitations/Caveats

Operators were not blinded to the invasive-FFR results at the time of calculating the CT based FFR and Bench-top measurements

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.