FFRangio Accuracy vs. Standard FFR (FAST-FFR)

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: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: FFRangio

• Study Type: Observational
• Enrollment (Actual): 382

Contacts and Locations

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

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

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuously scored FFR (FFRangio and Invasive FFR).	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		1 hour
Sensitivity and specificity of the dichotomously scored FFRangio measured index per lesion as measured by the site.		1 hour
Device Success	The ratio of produced FFRangio values from all FFRangio measurements that were started.	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.	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.	1 hour
Procedure related Adverse and Serious Adverse Events		1 hour
Device related Adverse and Serious Adverse Events		1 hour

Collaborators and Investigators

• Sponsor: CathWorks Ltd.
• Collaborators: CRF

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2017
• Primary Completion (Actual): June 8, 2018
• Study Completion (Actual): June 8, 2018

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 21, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID 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