Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease

This is a prospective, observational, single-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 in Multi-Vessel Disease.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Japan
  • Gifu, Japan, 500-8384
    • Gifu Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• 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, have multi-vessel coronary artery disease and have an invasive FFR measurement at two lesions at minimum. Each subject will undergo both the standard invasive FFRs and the investigational FFRangio.

Description

Inclusion Criteria:

• >18 years of age.
• Patients with stable angina or unstable angina or NSTEMI, with at least 1 stenoses ≥ 50% in two main vessels (LAD, LCX and/or RCA) each and in whom invasive FFR is being assessed at these stenoses.
• Patients undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.
• Written, informed consent.

Exclusion Criteria:

• Contraindication for FFR examination or administration of vasodilators.
• Clinical presentation of an acute infarct (STEMI) or presented with STEMI in past year.
• CTO in a target vessel.
• Prior CABG, valvular surgery, TAVI/TAVR, or heart transplantation.
• 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 lesions involve Left Main (stenosis ≥50%.)
• In-stent restenosis in a target vessel.
• Heavily diffused atherosclerosis diseases defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
• Target coronary vessels are supplied by major collaterals.
• Lesion is in ectatic segment which includes dilatation in diameter at least 1.5 times that of the adjacent normal coronary artery.
• Coronary angiograms not acquired per instructions as defined in the Study Protocol.

Study Plan

How is the study designed?

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

Collaborators and Investigators

• Sponsor: CathWorks Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 14, 2017
• Primary Completion (ACTUAL): May 2, 2018
• Study Completion (ACTUAL): May 2, 2018

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (ACTUAL): March 6, 2018

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-04

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: No
• product manufactured in and exported from the U.S.: No