Coronary Artery DiseaseFAST-FFRNCT03226262
FFRangio Accuracy vs. Standard FFR
An observational study of Coronary Artery Disease, run by CathWorks Ltd. at 9 sites in 4 countries.
Trial summary
This is a prospective, observational, multi-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically significant coronary stenosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- FFRangio
- Type of treatment
- Medical device
- How many people
- 382 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 27 Sep 2017to 8 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with stable angina, unstable angina or NSTEMI who are referred to coronary angiography and have an invasive FFR measurement with vasodilation in at least one coronary artery. Each subject will undergo both the standard invasive FFR and the investigational FFRangio.
Who may be able to join
- Male or female subjects, >18 years of age.
- Patients with stable angina or unstable angina or NSTEMI, and in whom invasive FFR is being assessed in a non-culprit stenosis in at least one coronary artery.
- Subject is undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.
- Provides written, informed consent (where required)
Who cannot join
- Contraindication for FFR examination or administration of vasodilators.
- Subject is presenting with acute infarct (STEMI) OR has documented prior STEMI on same side (right/left).
- CTO in target vessel.
- Prior CABG, heart transplant or valve surgery, or prior TAVI/TAVR.
- Known LVEF ≤45%.
- Arteries supplying akinetic or severe hypokinetic territories if already known based on prior imaging.
Show all 11Show fewer
- TIMI Grade 2 or lower at baseline.
- Target lesion involves Left Main (stenosis >50%).
- PCI with stent in target vessel in past 12 months, or target vessel involves in-stent restenosis.
- Severe, diffuse disease defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
- Target coronary vessel is supplied by major collaterals.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United States4 sites
Columbia University Medical Center/NewYork Presbyterian Hospital
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6061
St. Francis Hospital
Roslyn, New York, 11576
Stanford University
Stanford, California, 94305
Israel3 sites
Shaare Zedek Medical Center
Jerusalem, 9103102
HaSharon Hospital
Petah Tikva, 49100
Rabin Medical Center
Petah Tikva, 49100
About this study
This is a prospective, observational, multi-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically significant coronary stenosis.
- Conditions
- Coronary Artery Disease
- Being tested
- FFRangio
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFRangioDevice
FFRangio is a non-invasive image-based software device that provides physicians with a quantitative analysis of functional significance of the coronary lesion, similar to invasive FFR (Fractional Flow Reserve), and a qualitative three-dimensional model of the demonstrated coronary arteries, during routine PCI procedure. The CathWorks FFRangio software device is able to perform all required processing and calculations, based only on angiography images and hemodynamics information that are acquired during the coronary catheterization procedure.
The CathWorks FFRangioTM technology does not require any additional use of invasive devices, or any additional vasodilation treatment, as required by other known FFR techniques.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR
Sensitivity and specificity of the dichotomously scored FFRangio measured index per vessel as compared with invasively-derived FFR; Index ≤ 0.80 is scored "positive" while Index > 0.8 is negative.
Measured: 1 hour
Secondary outcomes (8)
Continuously scored FFR (FFRangio and Invasive FFR).
Regression of FFRangio on continuous FFR, with slope, intercept and the correlation coefficient.
Measured: 1 hour
Accuracy, Positive predictive value and negative predictive value per vessel and per lesion
Measured: 1 hour
Sensitivity and specificity of the dichotomously scored FFRangio measured index per lesion as measured by the site.
Measured: 1 hour
Device Success
The ratio of produced FFRangio values from all FFRangio measurements that were started.
Measured: 1 hour
Usability of FFRangio
A questionnaire will be completed by the user to assess how easy the system is for use and how intuitive it is.
Measured: 1 hour
Comprehensiveness of the FFRangio User Manual in providing adequate instructions
A questionnaire will be completed to measure if the user understands the main parts of the software instructions after reading the Instructions for use.
Measured: 1 hour
Procedure related Adverse and Serious Adverse Events
Measured: 1 hour
Device related Adverse and Serious Adverse Events
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start27 Sep 2017
- Primary completion8 Jun 2018
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- CathWorks Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRF
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226262
- Sponsor's protocol ID
- CWX-03
- Acronym
- FAST-FFR
- Status last verified
- Jun 2018
- First submitted
- 12 Jul 2017
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fearon WF, Achenbach S, Engstrom T, Assali A, Shlofmitz R, Jeremias A, Fournier S, Kirtane AJ, Kornowski R, Greenberg G, Jubeh R, Kolansky DM, McAndrew T, Dressler O, Maehara A, Matsumura M, Leon MB, De Bruyne B; FAST-FFR Study Investigators. Accuracy of Fractional Flow Reserve Derived From Coronary Angiography. Circulation. 2019 Jan 22;139(4):477-484. doi: 10.1161/CIRCULATIONAHA.118.037350.
PubMed 30586699
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FFRangio Accuracy vs. Standard FFR
- ClinicalTrials.gov ID
- NCT03226262
- Acronym / sponsor ID
- FAST-FFR / CWX-03
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- CathWorks Ltd.Industry (pharma, biotech, devices)
- Collaborators
- CRF
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 8 Jun 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, observational, multi-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically significant coronary stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with stable angina, unstable angina or NSTEMI who are referred to coronary angiography and have an invasive FFR measurement with vasodilation in at least one coronary artery. Each subject will undergo both the standard invasive FFR and the investigational FFRangio.
Key inclusion criteria (4 listed)
- Male or female subjects, >18 years of age.
- Patients with stable angina or unstable angina or NSTEMI, and in whom invasive FFR is being assessed in a non-culprit stenosis in at least one coronary artery.
- Subject is undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.
- Provides written, informed consent (where required)
Key exclusion criteria (11 listed)
- Contraindication for FFR examination or administration of vasodilators.
- Subject is presenting with acute infarct (STEMI) OR has documented prior STEMI on same side (right/left).
- CTO in target vessel.
- Prior CABG, heart transplant or valve surgery, or prior TAVI/TAVR.
- Known LVEF ≤45%.
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 |
|---|---|---|
| FFRangioFFRangio is a non-invasive image-based software device that provides physicians with a quantitative analysis of functional significance of the coronary lesion, similar to invasive FFR (Fractional Flow Reserve), and a qualitative three-dimensional model of the demonstrated coronary arteries, during routine PCI procedure. The CathWorks FFRangio software device is able to perform all required processing and calculations, based only on angiography images and hemodynamics information that are acquired during the coronary catheterization procedure. The CathWorks FFRangioTM technology does not require any additional use of invasive devices, or any additional vasodilation treatment, as required by other known FFR techniques. | Device | – |
Primary outcome
Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR
Time frame: 1 hour
Sensitivity and specificity of the dichotomously scored FFRangio measured index per vessel as compared with invasively-derived FFR; Index ≤ 0.80 is scored "positive" while Index > 0.8 is negative.
8 secondary outcomes
Continuously scored FFR (FFRangio and Invasive FFR).
Time frame: 1 hour
Accuracy, Positive predictive value and negative predictive value per vessel and per lesion
Time frame: 1 hour
Sensitivity and specificity of the dichotomously scored FFRangio measured index per lesion as measured by the site.
Time frame: 1 hour
Device Success
Time frame: 1 hour
Usability of FFRangio
Time frame: 1 hour
Comprehensiveness of the FFRangio User Manual in providing adequate instructions
Time frame: 1 hour
Procedure related Adverse and Serious Adverse Events
Time frame: 1 hour
Device related Adverse and Serious Adverse Events
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Derived from this study: PubMed 30586699Fearon WF, Achenbach S, Engstrom T, Assali A, Shlofmitz R, Jeremias A, Fournier S, Kirtane AJ, Kornowski R, Greenberg G, Jubeh R, Kolansky DM, McAndrew T, Dressler O, Maehara A, Matsumura M, Leon MB, De Bruyne B; FAST-FFR Study Investigators. Accuracy of Fractional Flow Reserve Derived From Coronary Angiography. Circulation. 2019 Jan 22;139(4):477-484. doi: 10.1161/CIRCULATIONAHA.118.037350.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by CathWorks Ltd. at 9 sites in 4 countries.
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 4 inclusion and 11 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 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Israel, Belgium, Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the dichotomously scored FFRangio measured index compared to invasive FFR (time frame: 1 hour). 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 NCT03226262, 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 25 Jun 2018.