CompletedNCT03226262FAST-FFRUpdated Jun 25, 2018

FFRangio Accuracy vs. Standard FFR

An observational study in Coronary Artery Disease, sponsored by CathWorks Ltd.. Completed at 9 sites in 4 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-25.

Sponsored by CathWorks Ltd. · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 382
Ages: 18 Years and older
Sex: All

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 studied

Coronary Artery Disease

Browse trials for

Coronary Artery Disease 5,581

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
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.

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

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 design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 382 participants (actual)
Patient registry: No

Interventions

DeviceFFRangio
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.

What researchers measure

Primary outcomes

Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR
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.
Time frame: 1 hour

Secondary outcomes

Continuously scored FFR (FFRangio and Invasive FFR).
Regression of FFRangio on continuous FFR, with slope, intercept and the correlation coefficient.
Time frame: 1 hour
Accuracy, Positive predictive value and negative predictive value per vessel and per lesion
Time frame: 1 hour
Sensitivity and specificity of the dichotomously scored FFRangio measured index per lesion as measured by the site.
Time frame: 1 hour
Device Success
The ratio of produced FFRangio values from all FFRangio measurements that were started.
Time frame: 1 hour
Usability of FFRangio
A questionnaire will be completed by the user to assess how easy the system is for use and how intuitive it is.
Time frame: 1 hour
Comprehensiveness of the FFRangio User Manual in providing adequate instructions
A questionnaire will be completed to measure if the user understands the main parts of the software instructions after reading the Instructions for use.
Time frame: 1 hour
Procedure related Adverse and Serious Adverse Events
Time frame: 1 hour
Device related Adverse and Serious Adverse Events
Time frame: 1 hour

Study locations

9 sites

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

References and documents

Publications

Fearon WF, Achenbach S, Engstrom T, Assali A, Shlofmitz R, Jeremias A, Fournier S, Kirtane AJ, Kornowski R, Greenberg G, Jubeh R, Kolansky DM, McAndrew T, Dressler O, Maehara A, Matsumura M, Leon MB, De Bruyne B; FAST-FFR Study Investigators. Accuracy of Fractional Flow Reserve Derived From Coronary Angiography. Circulation. 2019 Jan 22;139(4):477-484. doi: 10.1161/CIRCULATIONAHA.118.037350. PubMed 30586699 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03226262
Lead sponsor: CathWorks Ltd.
Collaborators: CRF
Responsible party: Sponsor
First posted: Jul 21, 2017
Start date: Sep 27, 2017
Primary completion: Jun 8, 2018
Completion: Jun 8, 2018
Last update: Jun 25, 2018

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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