Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement (ACIST-FFR)

Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement: the ACIST-FFR Study

This study will assess the differences between Fractional Flow Reserve (FFR) measurements made by the Navvus catheter and a commercially available pressure guidewire in up to 240 subjects where FFR is clinically indicated. All subjects will receive diagnostic treatment according to clinical indications and center standard practice.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: RXi System; Device: Pressure Wire

Detailed Description

The ACIST-FFR study is a prospective, open label, observational, multi-center study designed to assess the differences, if any, between FFR measured by the Navvus catheter and a commercially available 0.014-inch pressure guidewire (St. Jude Medical, Volcano, hereafter referred to as the PW) in subjects with coronary artery disease (CAD) undergoing coronary angiography. This will be accomplished by comparing the FFR measurement obtained with the ACIST Medical Systems RXi System and Navvus catheter with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time.

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital
    • Long Beach, California, United States, 90822
      • Long Beach VA Medical Center
    • Stanford, California, United States, 94305
      • Stanford School of Medicine
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Medstart Washington Hospital Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medicine
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Minneapolis, Minnesota, United States, 55433
      • Metropolitan Cardiology Heart and Vascular Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center / New York Presbyterian Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Lindner Research Center at The Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Cllinic Foundation

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: Non-Probability Sample

Study Population

Subjects 18 years of age or older, with single or multi-vessel CAD for whom FFR measurement is indicated to guide percutaneous coronary intervention strategy.

Description

General Inclusion Criteria:

• Subject is 18 years of age or older
• Subject has a clinical indication for coronary angiography
• Subject or subject's legal representative has the ability to understand and provide signed consent for participating in the study

Angiographic Inclusion Criteria:

• Vessel has a TIMI flow = 3
• Subject has de novo lesion which physician has determined has a clinical indication for FFR measurement
• RVD of the target lesion is assessed by the operator to be ≥2.25 mm.

General Exclusion Criteria:

• Subjects with acute ST-elevation or non-ST-elevation myocardial infarction as the indication for coronary angiography
• NYHA Class 4 severe heart failure

Angiographic Exclusion Criteria:

• Target vessel has angiographically visible or suspected thrombus.
• Target lesion is within a bypass graft.
• Angiographic evidence of a dissection prior to initiation of PW measurements.
• Target vessel contains excessive tortuosity or calcification.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants; Subjects who satisfy both general and angiographic inclusion/exclusion criteria, and who have the pressure measurement taken with the Navvus catheter.

Device: RXi System; Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve or FFR. Measurement of FFR requires simultaneously monitoring the blood pressures proximal and distal to a lesion. The RXi system includes a single use catheter (Navvus) with a pressure sensor for acquisition of the distal pressure. The proximal pressure is acquired by the guide catheter via an interface to the hospital hemodynamic monitor. The Navvus catheter interfaces to the RXi system console which includes embedded software, a user interface touch screen and associated electronics.; Other Names: ACIST Medical Systems RXi System; Navvus Catheter; Device: Pressure Wire; Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve or FFR.; Other Names: St. Jude PressueWire Aeris Guidewire; St. Jude PressureWire Certus Guidewire; Volcano PrimeWire Prestige

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FFR Measurements	Bias between Navvus and PW FFR measurements, as assessed by Bland-Altman analysis	Duration of FFR Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of device-related adverse effects	Rate of device-related adverse effects, for each system individually, and comparison between the two systems.	Duration of FFR Procedure
Slope of Passing-Bablok	Slope of Passing-Bablok fit between paired FFR measurements by Navvus and PW	Duration of FFR Procedure
Intercept of Passing-Bablok	Intercept of Passing-Bablok fit between paired FFR measurements by Navvus and PW	Duration of FFR Procedure
Comparability of FFR Measurements	Comparability of PW FFR and Navvus FFR measurements at PW FFR=0.80, by Passing-Bablok analysis.	Duration of FFR Procedure
Diagnostic FFR concurrence of stenosis significance	Concurrence of Navvus FFR diagnostic accuracy of stenosis significance, using PW FFR ≤0.80 as the standard.	Duration of FFR Procedure
Device success rate	Device success rate, defined as a valid FFR reading, for each system individually, and comparison between the two systems.	Duration of FFR Procedure
Mean drift	Mean drift, defined as the absolute difference between Pd/Pa at the equalization position after pullback and 1.00, for each system individually, and comparison between the two systems.	Duration of FFR Procedure
Rate of clinically significant drift	Rate of clinically significant drift, defined as drift >0.03, for each system individually, and comparison between the two systems.	Duration of FFR Procedure
PW FFR measurements with Navvus across and not across lesion	Comparisons between PW FFR measurements with Navvus across lesion and with Navvus not across lesion, including bias as assessed by Bland-Altman analysis.	Duration of FFR Procedure
Comparison of FFR Measurements including bias	Comparisons between PW (with Navvus present in lesion) and Navvus FFR measurements, including bias assessed by Bland-Altman analysis.	Duration of FFR Procedure
Correlation between Navvus diagnostic accuracy, bias, and angiographic characteristics	Relationship between Navvus diagnostic accuracy, bias, and angiographic characteristics such as lesion length and reference vessel diameter.	Duration of FFR Procedure
PW Pd/Pa diagnostic concurrence of stenosis signficance	PW Pd/Pa diagnostic accuracy (concurrence) of stenosis significance, using PW FFR ≤0.80 as the standard.	Duration of FFR Procedure
PW Pd/Pa measurements with Navvus across and not across lesion	Comparisons between PW Pd/Pa measurements with Navvus across lesion and with Navvus not across lesion, including bias as assessed by Bland-Altman analysis.	Duration of FFR Procedure
Comparison of Pd/Pa Measurements including bias	Comparisons between PW (with Navvus present in lesion) and Navvus Pd/Pa measurements, including bias assessed by Bland-Altman analysis.	Duration of FFR Procedure

Collaborators and Investigators

• Sponsor: Acist Medical Systems
• Investigators: Principal Investigator: William Fearon, MD, Stanford Cardiovascular Medical Clinic; Principal Investigator: Matthew Price, MD, Scripps Green Hospital

Publications and helpful links

General Publications

• Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
• Fearon WF, Bornschein B, Tonino PA, Gothe RM, Bruyne BD, Pijls NH, Siebert U; Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) Study Investigators. Economic evaluation of fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. Circulation. 2010 Dec 14;122(24):2545-50. doi: 10.1161/CIRCULATIONAHA.109.925396. Epub 2010 Nov 29.
• Fearon WF, Tonino PA, De Bruyne B, Siebert U, Pijls NH; FAME Study Investigators. Rationale and design of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) study. Am Heart J. 2007 Oct;154(4):632-6. doi: 10.1016/j.ahj.2007.06.012. Erratum In: Am Heart J. 2007 Dec;154(6):1243.
• King SB 3rd, Smith SC Jr, Hirshfeld JW Jr, Jacobs AK, Morrison DA, Williams DO, Feldman TE, Kern MJ, O'Neill WW, Schaff HV, Whitlow PL; ACC/AHA/SCAI; Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice guidelines. J Am Coll Cardiol. 2008 Jan 15;51(2):172-209. doi: 10.1016/j.jacc.2007.10.002. No abstract available.
• Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, De Bruyne B; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. J Am Coll Cardiol. 2010 Jul 13;56(3):177-84. doi: 10.1016/j.jacc.2010.04.012. Epub 2010 May 28.
• Fearon WF, Chambers JW, Seto AH, Sarembock IJ, Raveendran G, Sakarovitch C, Yang L, Desai M, Jeremias A, Price MJ; ACIST-FFR Study Investigators. ACIST-FFR Study (Assessment of Catheter-Based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement). Circ Cardiovasc Interv. 2017 Dec;10(12):e005905. doi: 10.1161/CIRCINTERVENTIONS.117.005905.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Catheter; Fractional Flow Reserve; Rapid Exchange
• 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: US100