Coronary Artery Disease
Conditions
Keywords
Fractional Flow Reserve, Rapid Exchange, Catheter
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.
Interventions
DEVICERXi 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.
DEVICEPressure 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.
Sponsors
Acist Medical Systems
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FFR Measurements | Duration of FFR Procedure | Bias between Navvus and PW FFR measurements, as assessed by Bland-Altman analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Slope of Passing-Bablok | Duration of FFR Procedure | Slope of Passing-Bablok fit between paired FFR measurements by Navvus and PW |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed