NCT02577484

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

December 6, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

October 13, 2015

Last Update Submit

December 5, 2016

Conditions

Coronary Artery Disease

Keywords

Fractional Flow ReserveRapid ExchangeCatheter

Outcome Measures

Primary Outcomes (1)

  • FFR Measurements

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

    Duration of FFR Procedure

Secondary Outcomes (14)

  • Slope of Passing-Bablok

    Duration of FFR Procedure

  • Intercept of Passing-Bablok

    Duration of FFR Procedure

  • Comparability of FFR Measurements

    Duration of FFR Procedure

  • Diagnostic FFR concurrence of stenosis significance

    Duration of FFR Procedure

  • Device success rate

    Duration of FFR Procedure

  • +9 more secondary outcomes

Study Arms (1)

Participants

Subjects who satisfy both general and angiographic inclusion/exclusion criteria, and who have the pressure measurement taken with the Navvus catheter.

Device: RXi SystemDevice: Pressure Wire

Interventions

RXi SystemDEVICE

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.

Also known as: ACIST Medical Systems RXi System, Navvus Catheter
Participants
Pressure WireDEVICE

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.

Also known as: St. Jude PressueWire Aeris Guidewire, St. Jude PressureWire Certus Guidewire, Volcano PrimeWire Prestige
Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • Subjects with acute ST-elevation or non-ST-elevation myocardial infarction as the indication for coronary angiography
  • NYHA Class 4 severe heart failure
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Long Beach VA Medical Center

Long Beach, California, 90822, United States

Location

Stanford School of Medicine

Stanford, California, 94305, United States

Location

Medstart Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Metropolitan Cardiology Heart and Vascular Institute

Minneapolis, Minnesota, 55433, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center / New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Cllinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (6)

  • 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.

    PMID: 21126973BACKGROUND

  • 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.

    PMID: 17892983BACKGROUND

  • 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.

    PMID: 18191745BACKGROUND

  • 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.

    PMID: 20537493BACKGROUND

  • 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.

    PMID: 19144937BACKGROUND

  • 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.

    PMID: 29246917DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • William Fearon, MD

    Stanford Cardiovascular Medical Clinic

    PRINCIPAL INVESTIGATOR

  • Matthew Price, MD

    Scripps Green Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 16, 2015

Study Start

November 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

December 6, 2016

Record last verified: 2016-10

Locations

US(12)