Clinical trial NCT02577484: Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement
Official title: Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement: the ACIST-FFR Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Fractional Flow Reserve
Rapid Exchange
Catheter
Lead sponsor: Acist Medical Systems
Sponsor class: INDUSTRY
First posted: 2015-10-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: FFR Measurements
timeFrame: Duration of FFR Procedure
Secondary outcomes:
measure: Slope of Passing-Bablok
timeFrame: Duration of FFR Procedure
measure: Intercept of Passing-Bablok
timeFrame: Duration of FFR Procedure
measure: Comparability of FFR Measurements
timeFrame: Duration of FFR Procedure
measure: Diagnostic FFR concurrence of stenosis significance
timeFrame: Duration of FFR Procedure
measure: Device success rate
timeFrame: Duration of FFR Procedure
measure: Mean drift
timeFrame: Duration of FFR Procedure
measure: Rate of clinically significant drift
timeFrame: Duration of FFR Procedure
measure: Rate of device-related adverse effects
timeFrame: Duration of FFR Procedure
measure: PW FFR measurements with Navvus across and not across lesion
timeFrame: Duration of FFR Procedure
measure: Comparison of FFR Measurements including bias
timeFrame: Duration of FFR Procedure
measure: Correlation between Navvus diagnostic accuracy, bias, and angiographic characteristics
timeFrame: Duration of FFR Procedure
measure: PW Pd/Pa diagnostic concurrence of stenosis signficance
timeFrame: Duration of FFR Procedure
measure: PW Pd/Pa measurements with Navvus across and not across lesion
timeFrame: Duration of FFR Procedure
measure: Comparison of Pd/Pa Measurements including bias
timeFrame: Duration of FFR Procedure
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Long Beach
country: United States
facility: Long Beach VA Medical Center
state: California
city: Stanford
country: United States
facility: Stanford School of Medicine
state: California
city: Washington
country: United States
facility: Medstart Washington Hospital Center
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Minneapolis
country: United States
facility: Metropolitan Cardiology Heart and Vascular Institute
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center / New York Presbyterian Hospital
state: New York
city: Cincinnati
country: United States
facility: Lindner Research Center at The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Cllinic Foundation
state: Ohio
Study officials:
affiliation: Stanford Cardiovascular Medical Clinic
name: William Fearon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Green Hospital
name: Matthew Price, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/j.ahj.2007.06.012.
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. No abstract available.
citation: 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.
citation: 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.
citation: 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.