Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study

February 8, 2018 updated by: CathWorks Ltd.
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah Tiqva, Israel
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study will enroll male and female subjects above the age of 18, with stable angina who were referred to coronary angiography and have an FFR measurement in at least one coronary artery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CathWorks Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

March 15, 2016

Study Completion (ACTUAL)

March 15, 2016

Study Registration Dates

First Submitted

December 19, 2016

First Submitted That Met QC Criteria

December 25, 2016

First Posted (ESTIMATE)

December 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFRAngio 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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