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

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ClinicalTrials.gov Identifier: NCT02577484
Recruitment Status : Unknown
Verified October 2016 by Acist Medical Systems.
Recruitment status was:  Active, not recruiting
First Posted : October 16, 2015
Last Update Posted : December 6, 2016
Sponsor:
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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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