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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Coronary Artery Disease 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.

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement: the ACIST-FFR Study
Study Start Date : November 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

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




Primary Outcome Measures :
  1. FFR Measurements [ Time Frame: Duration of FFR Procedure ]
    Bias between Navvus and PW FFR measurements, as assessed by Bland-Altman analysis


Secondary Outcome Measures :
  1. Slope of Passing-Bablok [ Time Frame: Duration of FFR Procedure ]
    Slope of Passing-Bablok fit between paired FFR measurements by Navvus and PW

  2. Intercept of Passing-Bablok [ Time Frame: Duration of FFR Procedure ]
    Intercept of Passing-Bablok fit between paired FFR measurements by Navvus and PW

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577484


Locations
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United States, California
Scripps Green Hospital
La Jolla, California, United States, 92037
Long Beach VA Medical Center
Long Beach, California, United States, 90822
Stanford School of Medicine
Stanford, California, United States, 94305
United States, District of Columbia
Medstart Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Illinois
University of Chicago Medicine
Chicago, Illinois, United States, 60637
United States, Iowa
Iowa Heart Center
West Des Moines, Iowa, United States, 50266
United States, Minnesota
Metropolitan Cardiology Heart and Vascular Institute
Minneapolis, Minnesota, United States, 55433
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center / New York Presbyterian Hospital
New York, New York, United States, 10032
United States, Ohio
Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Cllinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Acist Medical Systems
Investigators
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Principal Investigator: William Fearon, MD Stanford Cardiovascular Medical Clinic
Principal Investigator: Matthew Price, MD Scripps Green Hospital

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Acist Medical Systems
ClinicalTrials.gov Identifier: NCT02577484    
Other Study ID Numbers: US100
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: October 2016
Keywords provided by Acist Medical Systems:
Fractional Flow Reserve
Rapid Exchange
Catheter
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases