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OpenTrials
Completed

NCT Number: NCT03455244

Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gifu Heart Center

Gifu, 500-8384, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • >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.

Exclusion criteria

  • 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.
  • 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.

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

Sponsors and collaborators

Lead sponsor

CathWorks Ltd.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 6, 2018
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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