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Coronary Artery DiseaseACIST-FFRNCT02577484

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

An observational study of Coronary Artery Disease, run by Acist Medical Systems at 12 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
RXi System and Pressure Wire
Type of treatment
Medical device
How many people
240 participants
Where
12 sitesUnited States
Study dates
Nov 2015to Jan 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • University of Chicago Medicine

    Chicago, Illinois, 60637

  • Lindner Research Center at The Christ Hospital

    Cincinnati, Ohio, 45219

  • Cleveland Cllinic Foundation

    Cleveland, Ohio, 44195

  • Scripps Green Hospital

    La Jolla, California, 92037

  • Long Beach VA Medical Center

    Long Beach, California, 90822

  • Metropolitan Cardiology Heart and Vascular Institute

    Minneapolis, Minnesota, 55433

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Columbia University Medical Center / New York Presbyterian Hospital

    New York, New York, 10032

  • Saint Louis University

    St Louis, Missouri, 63110

  • Stanford School of Medicine

    Stanford, California, 94305

  • Medstart Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
RXi System, Pressure Wire
Keywords
Fractional Flow Reserve, Rapid Exchange, Catheter
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RXi SystemDevice

    Also called ACIST Medical Systems RXi System, Navvus Catheter

    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 WireDevice

    Also called St. Jude PressueWire Aeris Guidewire, St. Jude PressureWire Certus Guidewire, Volcano PrimeWire Prestige

    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.

Study groups in NCT02577484
Study groupRoleWhat they receive
ParticipantsSubjects who satisfy both general and angiographic inclusion/exclusion criteria, and who have the pressure measurement taken with the Navvus catheter.
Receives: Device: RXi System; Device: Pressure Wire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FFR Measurements

    Bias between Navvus and PW FFR measurements, as assessed by Bland-Altman analysis

    Measured: Duration of FFR Procedure

Secondary outcomes (14)

  1. Slope of Passing-Bablok

    Slope of Passing-Bablok fit between paired FFR measurements by Navvus and PW

    Measured: Duration of FFR Procedure

  2. Intercept of Passing-Bablok

    Intercept of Passing-Bablok fit between paired FFR measurements by Navvus and PW

    Measured: Duration of FFR Procedure

  3. Comparability of FFR Measurements

    Comparability of PW FFR and Navvus FFR measurements at PW FFR=0.80, by Passing-Bablok analysis.

    Measured: Duration of FFR Procedure

  4. Diagnostic FFR concurrence of stenosis significance

    Concurrence of Navvus FFR diagnostic accuracy of stenosis significance, using PW FFR ≤0.80 as the standard.

    Measured: Duration of FFR Procedure

  5. Device success rate

    Device success rate, defined as a valid FFR reading, for each system individually, and comparison between the two systems.

    Measured: Duration of FFR Procedure

  6. 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.

    Measured: Duration of FFR Procedure

  7. 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.

    Measured: Duration of FFR Procedure

  8. Rate of device-related adverse effects

    Rate of device-related adverse effects, for each system individually, and comparison between the two systems.

    Measured: Duration of FFR Procedure

  9. 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.

    Measured: Duration of FFR Procedure

  10. 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.

    Measured: Duration of FFR Procedure

  11. 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.

    Measured: Duration of FFR Procedure

  12. 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.

    Measured: Duration of FFR Procedure

  13. 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.

    Measured: Duration of FFR Procedure

  14. 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.

    Measured: Duration of FFR Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionJan 2017 (estimated)
  4. Study completionJan 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02577484
Sponsor's protocol ID
US100
Acronym
ACIST-FFR
Status last verified
Oct 2016
First submitted
13 Oct 2015
Last updated
6 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21126973

  • 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.

    PubMed 17892983

  • 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.

    PubMed 18191745

  • 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.

    PubMed 20537493

  • 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.

    PubMed 19144937

  • 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.

    PubMed 29246917

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Acist Medical Systems at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FFR Measurements (time frame: Duration of FFR Procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02577484, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.

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