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Completed

NCT Number: NCT03005028

Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study

In the present study we aim at validating the computation of FFRangio values from the angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a completely blinded manner. Investigation of a wide range of users in various conditions may strengthen the reliability of the FFRAngio measurements.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rabin Medical Center

Petah Tikva, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female above 18 years old age which undergo FFR as part of their standard care
  • TIMI Grade Flow is equal to 3
  • LVEF larger than 45%.
  • Subjects with multi-vessel coronary artery disease, with NSTEMI are allowed.

Exclusion criteria

  • Contraindicated for FFR examination or adenosine administration
  • STEMI
  • CTO
  • TIMI Grade Flow below 3
  • Arteries supplying akinetic or severe hypokinetic territories
  • Prior CABG on the study vessel
  • Left Main stenosis, In-stent restenosis and Collaterals
  • Diffused atherosclerosis diseases and tandem lesions
  • Aorto-ostial lesion

Treatment and study plan

Primary outcomes

  1. Lesion-specific image-based FFRAngio calculation, compared to the invasive FFR as the reference gold standard, with a blinded analysis yielding Bland- Altman of +/- 15% with 95% CI

    Time frame: 1 hour

    Immediately following the invasive FFR procedure.

Sponsors and collaborators

Lead sponsor

CathWorks Ltd.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 29, 2016
Registry last updated
Feb 9, 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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