FFRangio Accuracy vs. Standard FFR

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT03226262
• Lead Sponsor: CathWorks Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Study Start: 2017-09-27
• Status Verified: 2018-06
• Primary Completion: 2018-06-08
• Study Completion: 2018-06-08
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR	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.

Secondary Outcome Measures

Name	Time	Method
Continuously scored FFR (FFRangio and Invasive FFR).	1 hour	Regression of FFRangio on continuous FFR, with slope, intercept and the correlation coefficient.
Procedure related Adverse and Serious Adverse Events	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	1 hour	The ratio of produced FFRangio values from all FFRangio measurements that were started.
Comprehensiveness of the FFRangio User Manual in providing adequate instructions	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.
Usability of FFRangio	1 hour	A questionnaire will be completed by the user to assess how easy the system is for use and how intuitive it is.
Device related Adverse and Serious Adverse Events	1 hour

Trial Locations

Locations (9)

Stanford University; 🇺🇸 Stanford, California, United States

Columbia University Medical Center/NewYork Presbyterian Hospital; 🇺🇸 New York, New York, United States

St. Francis Hospital; 🇺🇸 Roslyn, New York, United States

OLV Ziekenhuis; 🇧🇪 Aalst, Belgium

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel

Rigs Hospital CPH; 🇩🇰 Copenhagen, Denmark

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel

HaSharon Hospital; 🇮🇱 Petah Tikva, Israel