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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Subjects who satisfy both general and angiographic inclusion/exclusion criteria, and who have the pressure measurement taken with the Navvus catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RXi System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| FFR Measurements | Bias between Navvus and PW FFR measurements, as assessed by Bland-Altman analysis | Duration of FFR Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Slope of Passing-Bablok | Slope of Passing-Bablok fit between paired FFR measurements by Navvus and PW | Duration of FFR Procedure |
| Intercept of Passing-Bablok | Intercept of Passing-Bablok fit between paired FFR measurements by Navvus and PW |
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General Inclusion Criteria:
Angiographic Inclusion Criteria:
General Exclusion Criteria:
Angiographic Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| William Fearon, MD | Stanford Cardiovascular Medical Clinic | Principal Investigator |
| Matthew Price, MD | Scripps Green Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Green Hospital | La Jolla | California | 92037 | United States | ||
| Long Beach VA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21126973 | Background | 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. | |
| 17892983 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 17, 2020 | |
| Reset | Jan 15, 2021 |
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|
|
| Pressure Wire | Device | 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. |
|
|
| Duration of FFR Procedure |
| Comparability of FFR Measurements | Comparability of PW FFR and Navvus FFR measurements at PW FFR=0.80, by Passing-Bablok analysis. | Duration of FFR Procedure |
| Diagnostic FFR concurrence of stenosis significance | Concurrence of Navvus FFR diagnostic accuracy of stenosis significance, using PW FFR ≤0.80 as the standard. | Duration of FFR Procedure |
| Device success rate | Device success rate, defined as a valid FFR reading, for each system individually, and comparison between the two systems. | Duration of FFR Procedure |
| Mean drift | 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. | Duration of FFR Procedure |
| Rate of clinically significant drift | Rate of clinically significant drift, defined as drift >0.03, for each system individually, and comparison between the two systems. | Duration of FFR Procedure |
| Rate of device-related adverse effects | Rate of device-related adverse effects, for each system individually, and comparison between the two systems. | Duration of FFR Procedure |
| PW FFR measurements with Navvus across and not across lesion | Comparisons between PW FFR measurements with Navvus across lesion and with Navvus not across lesion, including bias as assessed by Bland-Altman analysis. | Duration of FFR Procedure |
| Comparison of FFR Measurements including bias | Comparisons between PW (with Navvus present in lesion) and Navvus FFR measurements, including bias assessed by Bland-Altman analysis. | Duration of FFR Procedure |
| Correlation between Navvus diagnostic accuracy, bias, and angiographic characteristics | Relationship between Navvus diagnostic accuracy, bias, and angiographic characteristics such as lesion length and reference vessel diameter. | Duration of FFR Procedure |
| PW Pd/Pa diagnostic concurrence of stenosis signficance | PW Pd/Pa diagnostic accuracy (concurrence) of stenosis significance, using PW FFR ≤0.80 as the standard. | Duration of FFR Procedure |
| PW Pd/Pa measurements with Navvus across and not across lesion | Comparisons between PW Pd/Pa measurements with Navvus across lesion and with Navvus not across lesion, including bias as assessed by Bland-Altman analysis. | Duration of FFR Procedure |
| Comparison of Pd/Pa Measurements including bias | Comparisons between PW (with Navvus present in lesion) and Navvus Pd/Pa measurements, including bias assessed by Bland-Altman analysis. | Duration of FFR Procedure |
| Long Beach |
| California |
| 90822 |
| United States |
| Stanford School of Medicine | Stanford | California | 94305 | United States |
| Medstart Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| Metropolitan Cardiology Heart and Vascular Institute | Minneapolis | Minnesota | 55433 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Saint Louis University | St Louis | Missouri | 63110 | United States |
| Columbia University Medical Center / New York Presbyterian Hospital | New York | New York | 10032 | United States |
| Lindner Research Center at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Cleveland Cllinic Foundation | Cleveland | Ohio | 44195 | United States |
| Background |
| 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. doi: 10.1016/j.ahj.2007.06.012. |
| 18191745 | Background | 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. No abstract available. |
| 20537493 | Background | Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrom 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. |
| 19144937 | Background | Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom 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. |
| 29246917 | Derived | 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):e005905. doi: 10.1161/CIRCINTERVENTIONS.117.005905. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 17, 2020 | Jan 15, 2021 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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