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CompletedNCT03455244Updated Jun 25, 2018

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

An observational study in Multi Vessel Coronary Artery Disease, sponsored by CathWorks Ltd.. Completed at 1 site in Japan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-25.

Sponsored by CathWorks Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multi Vessel Coronary Artery Disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

  • DeviceFFRangio

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 hour

Secondary outcomes

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

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

    Time frame: 1 hour

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

    Time frame: 1 hour

06

Study locations

1 site
  • Gifu Heart Center
    Gifu, 500-8384, Japan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03455244
Lead sponsor
CathWorks Ltd.
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
Nov 14, 2017
Primary completion
May 2, 2018
Completion
May 2, 2018
Last update
Jun 25, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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