Multi Vessel Coronary Artery DiseaseNCT03455244
Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease
An observational study of Multi Vessel Coronary Artery Disease, run by CathWorks Ltd. at 1 site in Japan.
Trial summary
This is a prospective, observational, single-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 in Multi-Vessel Disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multi Vessel Coronary Artery Disease
- What is being tested?
- FFRangio
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- 14 Nov 2017to 2 May 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, have multi-vessel coronary artery disease and have an invasive FFR measurement at two lesions at minimum. Each subject will undergo both the standard invasive FFRs and the investigational FFRangio.
Who may be able to join
- >18 years of age.
- Patients with stable angina or unstable angina or NSTEMI, with at least 1 stenoses ≥ 50% in two main vessels (LAD, LCX and/or RCA) each and in whom invasive FFR is being assessed at these stenoses.
- Patients undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.
- Written, informed consent.
Who cannot join
- Contraindication for FFR examination or administration of vasodilators.
- Clinical presentation of an acute infarct (STEMI) or presented with STEMI in past year.
- CTO in a target vessel.
- Prior CABG, valvular surgery, TAVI/TAVR, or heart transplantation.
- Known LVEF ≤45%.
- Arteries supplying akinetic or severe hypokinetic territories if already known based on prior imaging.
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- TIMI Grade 2 or lower at baseline.
- Target lesions involve Left Main (stenosis ≥50%.)
- In-stent restenosis in a target vessel.
- Heavily diffused atherosclerosis diseases defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
- Target coronary vessels are supplied by major collaterals.
- Lesion is in ectatic segment which includes dilatation in diameter at least 1.5 times that of the adjacent normal coronary artery.
- Coronary angiograms not acquired per instructions as defined in the Study Protocol.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, observational, single-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 in Multi-Vessel Disease.
- Conditions
- Multi Vessel Coronary Artery Disease
- Being tested
- FFRangio
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 (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start14 Nov 2017
- Primary completion2 May 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi Vessel 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CathWorks Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455244
- Sponsor's protocol ID
- CWX-04
- Status last verified
- Jun 2018
- First submitted
- 28 Feb 2018
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease
- ClinicalTrials.gov ID
- NCT03455244
- Acronym / sponsor ID
- CWX-04
- Conditions
- Multi Vessel Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CathWorks Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 6 Mar 2018 (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, single-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 in Multi-Vessel Disease.
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, have multi-vessel coronary artery disease and have an invasive FFR measurement at two lesions at minimum. Each subject will undergo both the standard invasive FFRs and the investigational FFRangio.
Key inclusion criteria (4 listed)
- >18 years of age.
- Patients with stable angina or unstable angina or NSTEMI, with at least 1 stenoses ≥ 50% in two main vessels (LAD, LCX and/or RCA) each and in whom invasive FFR is being assessed at these stenoses.
- Patients undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.
- Written, informed consent.
Key exclusion criteria (13 listed)
- Contraindication for FFR examination or administration of vasodilators.
- Clinical presentation of an acute infarct (STEMI) or presented with STEMI in past year.
- CTO in a target vessel.
- Prior CABG, valvular surgery, TAVI/TAVR, or heart transplantation.
- 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.
2 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
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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multi Vessel Coronary Artery Disease, run by CathWorks Ltd. at 1 site in Japan.
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 13 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 1 site in Japan. 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?
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.