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

• ClinicalTrials.gov Identifier: NCT02577484
• Recruitment Status: Unknown
• First Posted: October 16, 2015
• Last Update Posted: December 6, 2016
• Sponsor: Acist Medical Systems
• Information provided by (Responsible Party): Acist Medical Systems

Tracking Information

• First Submitted Date: October 13, 2015
• First Posted Date: October 16, 2015
• Last Update Posted Date: December 6, 2016
• Study Start Date: November 2015
• Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 14, 2015)

FFR Measurements [ Time Frame: Duration of FFR Procedure ]

Bias between Navvus and PW FFR measurements, as assessed by Bland-Altman analysis

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 14, 2015)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement
• Official Title: Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement: the ACIST-FFR Study
• Brief Summary: 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.
• 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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Coronary Artery Disease

Intervention

• 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

Study Groups/Cohorts

Participants

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

Interventions:

• Device: RXi System
• Device: Pressure Wire

Publications *

• 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. 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.
• Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrøm 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.
• Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrøm 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, 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). pii: e005905. doi: 10.1161/CIRCINTERVENTIONS.117.005905.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 14, 2015): 240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2017
• Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02577484
• Other Study ID Numbers: US100
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Acist Medical Systems
• Study Sponsor: Acist Medical Systems
• Collaborators: Not Provided

Investigators

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

• PRS Account: Acist Medical Systems
• Verification Date: October 2016