FFRangio Accuracy vs. Standard FFR

Coronary Artery Disease Clinical Trial

— FAST-FFR  

Official title:

FFRangio Accuracy vs. Standard FFR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226262
• Other study ID #: CWX-03
• Status: Completed
• Start date: September 27, 2017
• Est. completion date: June 8, 2018

Study information

• Verified date: June 2018
• Source: CathWorks Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: June 8, 2018
• Est. primary completion date: June 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• FFRangio
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.

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis	Aalst
Denmark	Rigs Hospital CPH	Copenhagen
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Rabin Medical Center	Petach Tikva
Israel	HaSharon Hospital	Petah Tikva
United States	Columbia University Medical Center/NewYork Presbyterian Hospital	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	St. Francis Hospital	Roslyn	New York
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
CathWorks Ltd.	CRF

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Continuously scored FFR (FFRangio and Invasive FFR).	Regression of FFRangio on continuous FFR, with slope, intercept and the correlation coefficient.	1 hour
Secondary	Accuracy, Positive predictive value and negative predictive value per vessel and per lesion		1 hour
Secondary	Sensitivity and specificity of the dichotomously scored FFRangio measured index per lesion as measured by the site.		1 hour
Secondary	Device Success	The ratio of produced FFRangio values from all FFRangio measurements that were started.	1 hour
Secondary	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
Secondary	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
Secondary	Procedure related Adverse and Serious Adverse Events		1 hour
Secondary	Device related Adverse and Serious Adverse Events		1 hour