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OpenTrials
Completed

NCT Number: NCT03226262

FFRangio Accuracy vs. Standard FFR

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OLV Ziekenhuis, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

FFRangio

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Continuously scored FFR (FFRangio and Invasive FFR).

    Time frame: 1 hour

    Regression of FFRangio on continuous FFR, with slope, intercept and the correlation coefficient.

  2. Accuracy, Positive predictive value and negative predictive value per vessel and per lesion

    Time frame: 1 hour

  3. Sensitivity and specificity of the dichotomously scored FFRangio measured index per lesion as measured by the site.

    Time frame: 1 hour

  4. Device Success

    Time frame: 1 hour

    The ratio of produced FFRangio values from all FFRangio measurements that were started.

  5. Usability of FFRangio

    Time frame: 1 hour

    A questionnaire will be completed by the user to assess how easy the system is for use and how intuitive it is.

  6. Comprehensiveness of the FFRangio User Manual in providing adequate instructions

    Time frame: 1 hour

    A questionnaire will be completed to measure if the user understands the main parts of the software instructions after reading the Instructions for use.

  7. Procedure related Adverse and Serious Adverse Events

    Time frame: 1 hour

  8. Device related Adverse and Serious Adverse Events

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

CathWorks Ltd.

Industry

Collaborators

  • CRF

Registry information

Acronym: FAST-FFR

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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