Coronary Artery DiseaseFUSIONNCT04356027

FUnctional diagnoSIs of corONary Stenosis (FUSION)

An observational study of Coronary Artery Disease and Coronary Stenosis, run by Abbott Medical Devices at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Coronary Stenosis
What is being tested?: ICA (Invasive Coronary Angiography), OCT and FFR
Type of treatment: Surgery or procedure
How many people: 312 participants
Where: 28 sitesUnited States
Study dates: 26 Jun 2020to 15 Oct 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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:

Show all 38Show fewer

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

Who cannot join

None listed.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Austin Heart
Austin, Texas, 78756
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Holy Spirit Hospital
Camp Hill, Pennsylvania, 17011
Mercy Hospital
Coon Rapids, Minnesota, 55433
Atlanta VA Medical Center
Decatur, Georgia, 30033
VA Medical Center Durham
Durham, North Carolina, 27705
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
The Cardiac & Vascular Institute Research Foundation, LLC
Gainesville, Florida, 32605
University of Texas Medical Branch (UTMB)
Galveston, Texas, 77555-0144
Greenville Health System
Greenville, South Carolina, 29605-5601
Memorial Hermann Hospital
Houston, Texas, 77030
Heart Center Research, LLC.
Huntsville, Alabama, 35801
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Loyola University Medical Center
Maywood, Illinois, 60153
St. Patrick Hospital
Missoula, Montana, 59802
New York University Hospital
New York, New York, 10016
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10032
VA Palo Alto Medical Center
Palo Alto, California, 94604
Providence St. Vincent Medical Center
Portland, Oregon, 97225
St. Francis Hospital
Roslyn, New York, 11576
UCLA Medical Center Santa Monica
Santa Monica, California, 90404
HonorHealth
Scottsdale, Arizona, 85258
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center - Moses Division
The Bronx, New York, 10467
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, 67214-3882
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226

Other trials in United States

About this study

Official title: Validation of OCT-based FUnctional diagnoSIs of corONary Stenosis (FUSION)

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).

Read the 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.

Conditions: Coronary Artery Disease, Coronary Stenosis
Being tested: ICA (Invasive Coronary Angiography), OCT, FFR, VFR Analysis
Keywords: Virtual Flow Reserve (VFR), Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), Percutaneous Coronary Intervention (PCI), OPTIS System, Dragonfly, PressureWire X
Medical subject headings: Coronary Artery Disease, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ICA (Invasive Coronary Angiography)Procedure or surgery
Patients will undergo a Pre-PCI Angiography
OCTProcedure or surgery
OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure
FFRProcedure or surgery
FFR will be measured
VFR AnalysisOther
VFR will be calculated offline using the OCT pullback images

Study groups in NCT04356027
Study group	Role	What they receive
Standard of Care: Angiography, OCT, FFR, and VFR		Patients will have Pre-OCT Angiography, OCT pullbacks, a FFR measurement and a VFR analysis Receives: Procedure: ICA (Invasive Coronary Angiography); Procedure: OCT; Procedure: FFR; Other: VFR Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline (pre-procedure) and immediately post-procedure

Secondary outcomes (4)

Overall Diagnostic Accuracy
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.
Measured: Baseline (pre-procedure) and immediately post-procedure
Positive Predictive Value (PPV) and Negative Predictive Value (NPV)
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.
Measured: Baseline (pre-procedure) and immediately post-procedure
Correlation Between VFR and FFR
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.
Measured: Baseline (pre-procedure) and immediately post-procedure (post-procedure)
Area Under Curve (AUC) Against FFR
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.
Measured: Baseline (pre-procedure) and immediately post-procedure (post-procedure)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 202015 Oct 2021

First posted21 Apr 2020
Study start26 Jun 2020
Primary completion15 Oct 2021
Study completion15 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 312 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04356027
Sponsor's protocol ID: ABT-CIP-10331
Acronym: FUSION
Status last verified: Jan 2025
First submitted: 20 Apr 2020
Last updated: 21 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38525609

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of OCT-based FUnctional diagnoSIs of corONary Stenosis (FUSION)
ClinicalTrials.gov ID: NCT04356027
Acronym / sponsor ID: FUSION / ABT-CIP-10331
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
Study type: Observational
Recruitment status: Completed
Enrolment: 312 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 26 Jun 2020 (actual)
Primary completion: 15 Oct 2021 (actual)
Study completion: 15 Oct 2021 (actual)
First posted: 21 Apr 2020 (actual)
Results: Posted 21 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Standard of Care: Angiography, OCT, FFR, and VFR	–	Procedure: ICA (Invasive Coronary Angiography), Procedure: OCT, Procedure: FFR, Other: VFR AnalysisPatients will have Pre-OCT Angiography, OCT pullbacks, a FFR measurement and a VFR analysis

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This clinical investigation will enroll male and female subjects from the general interventional cardiology population.

Key inclusion criteria (38 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ICA (Invasive Coronary Angiography)Patients will undergo a Pre-PCI Angiography	Procedure or surgery	Standard of Care: Angiography, OCT, FFR, and VFR
OCTOCT pullback images will be collected pre-PCI and (optional) post-PCI procedure	Procedure or surgery	Standard of Care: Angiography, OCT, FFR, and VFR
FFRFFR will be measured	Procedure or surgery	Standard of Care: Angiography, OCT, FFR, and VFR
VFR AnalysisVFR will be calculated offline using the OCT pullback images	Other	Standard of Care: Angiography, OCT, FFR, and VFR

Primary outcome

Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR)
Time frame: Baseline (pre-procedure) and immediately post-procedure
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).

4 secondary outcomes

Overall Diagnostic Accuracy
Time frame: Baseline (pre-procedure) and immediately post-procedure
Positive Predictive Value (PPV) and Negative Predictive Value (NPV)
Time frame: Baseline (pre-procedure) and immediately post-procedure
Correlation Between VFR and FFR
Time frame: Baseline (pre-procedure) and immediately post-procedure (post-procedure)
Area Under Curve (AUC) Against FFR
Time frame: Baseline (pre-procedure) and immediately post-procedure (post-procedure)

Results and safety

Results posted to the registry on 21 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care: Angiography, OCT, FFR, and VFR	224	224

Primary outcome: Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR)

Time frame: Baseline (pre-procedure) and immediately post-procedure. Number. Unit: vessels

Measure	Standard of Care: Angiography, OCT, FFR, and VFR n = 224
Sensitivity	82
Specificity	136

Population analysed: The primary analysis population included vessels in enrolled subjects having acceptable OCT pullbacks and pressure tracings for computing both the VFR and FFR indices. This is a single-arm study, so there is no data to report per arm, only data collected at different time points throughout the study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Immediately post-procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care: Angiography, OCT, FFR, and VFR	5 of 312 (1.6%)	3 of 312 (1%)	0 of 312

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38525609Jeremias 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Allen Jeremias, MD principal investigator

St. Francis Hospital,Roslyn,NY, United States

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Coronary Stenosis, run by Abbott Medical Devices at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR) (time frame: Baseline (pre-procedure) and immediately post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04356027, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.