FFRangio Accuracy vs. Standard FFR

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

382 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-27

Study Completion Date

2018-06-08

Brief Summary

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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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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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FFRangio

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes