Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement

Coronary Artery Disease Clinical Trial

— ACIST-FFR  

Official title:

Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement: the ACIST-FFR Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02577484
• Other study ID #: US100
• Status: Active, not recruiting
• Phase: N/A
• First received: October 13, 2015
• Last updated: December 5, 2016
• Start date: November 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2016
• Source: Acist Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

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.
• 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.

Locations

Country	Name	City	State
United States	University of Chicago Medicine	Chicago	Illinois
United States	Lindner Research Center at The Christ Hospital	Cincinnati	Ohio
United States	Cleveland Cllinic Foundation	Cleveland	Ohio
United States	Scripps Green Hospital	La Jolla	California
United States	Long Beach VA Medical Center	Long Beach	California
United States	Metropolitan Cardiology Heart and Vascular Institute	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	Columbia University Medical Center / New York Presbyterian Hospital	New York	New York
United States	Saint Louis University	Saint Louis	Missouri
United States	Stanford School of Medicine	Stanford	California
United States	Medstart Washington Hospital Center	Washington	District of Columbia
United States	Iowa Heart Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Acist Medical Systems

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. Erratum in: Am Heart J. 2007 Dec;154(6):1243. — View Citation

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. — View Citation

Pijls NH, Fearon WF, Tonino PA, Siebert U, Ikeno F, Bornschein B, van't Veer M, Klauss V, Manoharan G, Engstrøm 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. — View Citation

Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrøm 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FFR Measurements	Bias between Navvus and PW FFR measurements, as assessed by Bland-Altman analysis	Duration of FFR Procedure	No
Secondary	Slope of Passing-Bablok	Slope of Passing-Bablok fit between paired FFR measurements by Navvus and PW	Duration of FFR Procedure	No
Secondary	Intercept of Passing-Bablok	Intercept of Passing-Bablok fit between paired FFR measurements by Navvus and PW	Duration of FFR Procedure	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No