Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement
- Conditions
- Coronary Artery Disease
- Interventions
- Device: RXi SystemDevice: Pressure Wire
- Registration Number
- NCT02577484
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants Pressure Wire Subjects who satisfy both general and angiographic inclusion/exclusion criteria, and who have the pressure measurement taken with the Navvus catheter. Participants RXi System Subjects who satisfy both general and angiographic inclusion/exclusion criteria, and who have the pressure measurement taken with the Navvus catheter.
- Primary Outcome Measures
Name Time Method FFR Measurements Duration of FFR Procedure Bias between Navvus and PW FFR measurements, as assessed by Bland-Altman analysis
- Secondary Outcome Measures
Name Time Method Slope of Passing-Bablok Duration of FFR Procedure Slope of Passing-Bablok fit between paired FFR measurements by Navvus and PW
Intercept of Passing-Bablok Duration of FFR Procedure Intercept of Passing-Bablok fit between paired FFR measurements by Navvus and PW
Comparability of FFR Measurements 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 Duration of FFR Procedure Concurrence of Navvus FFR diagnostic accuracy of stenosis significance, using PW FFR ≤0.80 as the standard.
Device success rate 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 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 Duration of FFR Procedure Rate of clinically significant drift, defined as drift \>0.03, for each system individually, and comparison between the two systems.
PW Pd/Pa diagnostic concurrence of stenosis signficance 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 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 Duration of FFR Procedure Comparisons between PW (with Navvus present in lesion) and Navvus Pd/Pa measurements, including bias assessed by Bland-Altman analysis.
Rate of device-related adverse effects 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 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 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 Duration of FFR Procedure Relationship between Navvus diagnostic accuracy, bias, and angiographic characteristics such as lesion length and reference vessel diameter.
Trial Locations
- Locations (12)
Long Beach VA Medical Center
🇺🇸Long Beach, California, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Stanford School of Medicine
🇺🇸Stanford, California, United States
Cleveland Cllinic Foundation
🇺🇸Cleveland, Ohio, United States
Columbia University Medical Center / New York Presbyterian Hospital
🇺🇸New York, New York, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Medstart Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Metropolitan Cardiology Heart and Vascular Institute
🇺🇸Minneapolis, Minnesota, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Lindner Research Center at The Christ Hospital
🇺🇸Cincinnati, Ohio, United States