FFRangio Accuracy vs. Standard FFR (FAST-FFR)

June 21, 2018 updated by: CathWorks Ltd.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
382

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

  • Belgium
      • Aalst, Belgium, 9300
        • OLV Ziekenhuis
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigs Hospital CPH
  • Israel
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center
      • Petah Tikva, Israel, 49100
        • Hasharon Hospital
  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center/NewYork Presbyterian Hospital
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-6061
        • University of Pennsylvania

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Subjects with stable angina, unstable angina or NSTEMI who are referred to coronary angiography and have an invasive FFR measurement with vasodilation in at least one coronary artery. Each subject will undergo both the standard invasive FFR and the investigational FFRangio.

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR
Time Frame: 1 hour
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.
1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Continuously scored FFR (FFRangio and Invasive FFR).
Time Frame: 1 hour
Regression of FFRangio on continuous FFR, with slope, intercept and the correlation coefficient.
1 hour
Accuracy, Positive predictive value and negative predictive value per vessel and per lesion
Time Frame: 1 hour
1 hour
Sensitivity and specificity of the dichotomously scored FFRangio measured index per lesion as measured by the site.
Time Frame: 1 hour
1 hour
Device Success
Time Frame: 1 hour
The ratio of produced FFRangio values from all FFRangio measurements that were started.
1 hour
Usability of FFRangio
Time Frame: 1 hour
A questionnaire will be completed by the user to assess how easy the system is for use and how intuitive it is.
1 hour
Comprehensiveness of the FFRangio User Manual in providing adequate instructions
Time Frame: 1 hour
A questionnaire will be completed to measure if the user understands the main parts of the software instructions after reading the Instructions for use.
1 hour
Procedure related Adverse and Serious Adverse Events
Time Frame: 1 hour
1 hour
Device related Adverse and Serious Adverse Events
Time Frame: 1 hour
1 hour

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CathWorks Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CRF

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 8, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CWX-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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