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FFRangio Accuracy vs. Standard FFR

NCT03226262 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 382

Last updated 2018-06-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

  • CRF

    collaborator UNKNOWN

  • CathWorks Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-27
Primary Completion
2018-06-08
Completion
2018-06-08
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03226262 on ClinicalTrials.gov