<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03227588</url>
  </required_header>
  <id_info>
    <org_study_id>966635</org_study_id>
    <nct_id>NCT03227588</nct_id>
  </id_info>
  <brief_title>Evaluation of the Opsens Fractional Flow Reserve (FFR) Wire as a &quot;Work Horse&quot; Wire</brief_title>
  <official_title>Evaluation of the Opsens Fractional Flow Reserve (FFR) Wire as a &quot;Work Horse&quot; Wire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Arkansas Veterans Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Arkansas Veterans Healthcare System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of fractional flow reserve (FFR) has improved outcomes in percutaneous coronary&#xD;
      interventions (PCI) in patients with symptomatic stable coronary artery disease (CAD) with&#xD;
      intermediate angiographic stenoses. It is a clinical tool used routinely in cardiac&#xD;
      catheterization laboratories throughout the world including the Little Rock VA Hospital. The&#xD;
      technique utilizes a pressure transducer constructed as part of an 0.014&quot; guidewire. An FFR&#xD;
      of &gt;0.80 has been linked with myocardial ischemia found with nuclear stress and dobutamine&#xD;
      echo stress testing. The FAME trial clearly demonstrated its value in improving long-term&#xD;
      outcomes as compared to use of angiography alone. As such, the use of FFR is incorporated&#xD;
      into both AHA ACC and European PCI guideline recommendations as part of routine care for&#xD;
      intermediate lesions. A &quot;work horse&quot; guide wire is so defined because it can be used in most&#xD;
      PCI cases. It combines a low tip load (to avoid intimal dissection, with excellent (ideally,&#xD;
      one to one) torque transmission and trackability through tortuous lesions. Recently the FDA&#xD;
      has approved an FFR guide wire, OptoWire, (Opsens, Quebec City, Quebec, CAN) which uses light&#xD;
      transmission to measure pressure rather than electrical transduction wires. The primary&#xD;
      purpose of the present study is to determine how effective this wire is as a work horse wire&#xD;
      in patients in whom FFR is required. The OptoWire may also have the advantage of less &quot;drift&quot;&#xD;
      occurring during the procedure. Drift refers to the change in pressure due to issues related&#xD;
      to the wire and measuring system, rather than a true change in pressure. All current FFR wire&#xD;
      systems demonstrate some degree of drift requiring measuring pressure of the wire in the&#xD;
      aorta after the procedure is completed to determine if, and to what extent, drift has&#xD;
      occurred. Thus, a secondary aim of this study will determine the degree of drift.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      EVALUATION OF THE OPSENS FRACTIONAL FLOW RESERVE (FFR) WIRE AS A &quot;WORK HORSE&quot; WIRE&#xD;
&#xD;
      INVESTIGATORS:&#xD;
&#xD;
      PRINCIPAL INVESTIGATOR: BARRY F URETSKY, MD CO-INVESTIGATOR: ABDUL HAKEEM, MD&#xD;
      CO-INVESTIGATOR: MALEK AL-HAWWAS, MD&#xD;
&#xD;
      Introduction The use of fractional flow reserve (FFR) has improved outcomes in percutaneous&#xD;
      coronary interventions (PCI) in patients with symptomatic stable coronary artery disease&#xD;
      (CAD) with intermediate angiographic stenoses. It is a clinical tool used routinely in&#xD;
      cardiac catheterization laboratories throughout the world including the Little Rock VA&#xD;
      hospital. The technique utilizes a pressure transducer constructed as part of an 0.014&quot;&#xD;
      guidewire. The wire is passed distal to the stenosis. Under the condition of maximal&#xD;
      hyperemia induced by a drug, typically adenosine, the pressure proximal to the stenosis, i.e.&#xD;
      aortic pressure or Pa and the pressure distal to the stenosis, Pd, are measured. The ratio,&#xD;
      Pd/Pa, under maximal flow or hyperemia is known as the fractional flow reserve (FFR). An FFR&#xD;
      of &lt;0.80 has been correlated with observed myocardial ischemia using other diagnostic&#xD;
      methods, particularly nuclear stress and dobutamine echo stress testing. The FAME trial&#xD;
      clearly demonstrated its value in improving long-term outcomes as compared to use of&#xD;
      angiography alone (1). As such, the use of FFR is incorporated into both AHA ACC and European&#xD;
      PCI guideline recommendations as part of routine care for intermediate lesions (2,3).&#xD;
&#xD;
      One of the limitations of the use of the FFR pressure wire itself is that its handling&#xD;
      characteristics are somewhat inferior to a standard &quot;work horse&quot; guide wire used for PCI. A&#xD;
      &quot;work horse&quot; guide wire is so defined because it can be used in most PCI cases. It combines a&#xD;
      low tip load (to avoid intimal dissection) with excellent (ideally, one-to-one) torque&#xD;
      transmission and trackability through tortuous lesions. There are several different work&#xD;
      horse wires available. Although the wires may be different for different Cath Labs and&#xD;
      operators, the wires are universally used to maximize safety, efficacy, and efficiency of&#xD;
      PCI.&#xD;
&#xD;
      In patients specifically requiring FFR to determine the value of PCI, it would be ideal if an&#xD;
      FFR wire was as effective as a work horse wire so it could be used in difficult-to-traverse&#xD;
      lesions. However, due to the complex electronics within current FFR wires, handling&#xD;
      characteristics of previously used wires are inferior to current work horse wires. Recently&#xD;
      the FDA has approved an FFR guide wire, OptoWire, (Opsens, Quebec City, Quebec, CAN) using&#xD;
      light transmission to measure pressure rather than electrical transduction (4). It is&#xD;
      commercially available in the United States. Its handling characteristics appear to approach&#xD;
      that of a work horse guide wire and may represent an improvement over electrical transduction&#xD;
      wires. The primary purpose of the present study is to determine how effective this wire is as&#xD;
      a work horse wire in patients in whom FFR is required.&#xD;
&#xD;
      The OptoWire may also have the advantage of less &quot;drift&quot; occuring during the procedure. Drift&#xD;
      refers to the change in pressure due to issues related to the wire and measuring system,&#xD;
      rather than a true change in pressure. All current FFR wire systems demonstrate some degree&#xD;
      of drift requiring measuring pressure of the wire in the aorta after the procedure is&#xD;
      completed to determine if, and to what extent, drift has occurred. Thus, a secondary aim of&#xD;
      this study will determine the degree of drift.&#xD;
&#xD;
      In clinical practice, FFR is performed before, and often after, PCI. In a study of 574&#xD;
      patients treated at the Little Rock VA (IRB Study, #779601), teh investigators found that&#xD;
      approximately 20% of angiographically optimized PCI still had an ischemic FFR. The&#xD;
      investigators further found that this ischemic value could be improved by further treatments&#xD;
      including balloon angioplasty and stenting. Thus, the secondary purpose is to measure FFR&#xD;
      after successful PCI to ascertain the incidence of persistently ischemic FFR after optimized&#xD;
      angiographic stenting to confirm the result from out previous study.&#xD;
&#xD;
      Statistical analysis&#xD;
&#xD;
      This study is descriptive. It will use means and standard deviation for continuous variables&#xD;
      and prevalence or incidence in percentages as appropriate to show results. As there is no&#xD;
      comparator group, comparative statistics will not be employed.&#xD;
&#xD;
      Research aspect of study&#xD;
&#xD;
      The research aspect of the study is limited to the systematic collection and analysis of data&#xD;
      using the Opsens FFR wire with plan for publication. The other aspects of the study are&#xD;
      considered part of routine clinical care. They include passage of FFR wire, measurement of&#xD;
      FFR pre- and post-PCI, and performance of PCI itself.&#xD;
&#xD;
      Significance of study&#xD;
&#xD;
      A wire that can be used as a workhorse as well as be able to measure FFR would be of great&#xD;
      value. The more effective and efficient is the FFR wire in not only measuring pre-PCI FFR but&#xD;
      being able to be used for PCI and be stable and durable enough to be used for post-PCI&#xD;
      optimization, the greater is the probability that this approach will be more generally&#xD;
      adopted into clinical practice. Demonstration that the Opsens FFR wire is effective in this&#xD;
      regard should further this goal.&#xD;
&#xD;
      The investigators previously demonstrated that 21% or about 1 in 5 patients had an ischemic&#xD;
      FFR after satisfactory angiographic result. This study will confirm previous results or&#xD;
      suggest either an over- or under-estimation of that incidence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 10, 2017</start_date>
  <completion_date type="Anticipated">December 10, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 10, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Opsens FFR Wire Performance</measure>
    <time_frame>Acute result at end of procedure</time_frame>
    <description>Satisfactory performance is defined as the ability to perform the entire PCI plus measure FFR pre and post PCI with drift &lt;0.05.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Ischemic or Low Non-ischemic FFR post PCI requiring further intervention</measure>
    <time_frame>Acute result at end of procedure</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Coronary Artery Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Fractional Flow Reserve</intervention_name>
    <description>This is a prospective data collection study for patients that have undergone FFR.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients (age 18-89 years old) eligible and in whom the operator has performed FFR will be&#xD;
        included to systematically evaluate the performance of the OptoWire FFR wire. A total of&#xD;
        1000 consecutive patients deemed to require FFR as part of clinical care will be included.&#xD;
        It is felt that 1000 patients represent a reasonable sample size to study the OptoWire FFR&#xD;
        wire handling characteristics, the primary endpoint of the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients (age 18-89 years old) eligible and in whom the operator has performed FFR will be&#xD;
        included to systematically evaluate the performance of the OptoWire FFR wire. A total of&#xD;
        1000 consecutive patients deemed to require FFR as part of clinical care will be included.&#xD;
        It is felt that 1000 patients represent a reasonable sample size to study the OptoWire FFR&#xD;
        wire handling characteristics, the primary endpoint of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Not a candidate for FFR&#xD;
&#xD;
          2. Chronic total occlusion lesion&#xD;
&#xD;
          3. Hemodynamically unstable&#xD;
&#xD;
          4. Saphenous vein graft lesions -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Barry F. Uretsky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CAVHS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Barry F. Uretsky, MD</last_name>
    <phone>501-257-1000</phone>
    <email>barry.uretsky@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kristin G Miller, RN, CCRC</last_name>
    <phone>501-257-5893</phone>
    <email>kristin.miller4@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>John L. McClellan Memorial Veterans Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristin Miller, RN</last_name>
      <phone>501-257-5893</phone>
      <email>kristin.miller4@va.gov</email>
    </contact>
    <investigator>
      <last_name>Barry F Uretsky, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://opsensmedical.com/products/optowire/</url>
    <description>Optowire product information</description>
  </link>
  <reference>
    <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>
    <PMID>19144937</PMID>
  </reference>
  <reference>
    <citation>Costa F, Ariotti S, Valgimigli M, Kolh P, Windecker S; Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Perspectives on the 2014 ESC/EACTS Guidelines on Myocardial Revascularization : Fifty Years of Revascularization: Where Are We and Where Are We Heading? J Cardiovasc Transl Res. 2015 Jun;8(4):211-20. doi: 10.1007/s12265-015-9632-6. Epub 2015 May 19.</citation>
    <PMID>25986910</PMID>
  </reference>
  <reference>
    <citation>Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011 Dec 6;58(24):e44-122. doi: 10.1016/j.jacc.2011.08.007. Epub 2011 Nov 7. No abstract available.</citation>
    <PMID>22070834</PMID>
  </reference>
  <reference>
    <citation>Agarwal SK, Kasula S, Hacioglu Y, Ahmed Z, Uretsky BF, Hakeem A. Utilizing Post-Intervention Fractional Flow Reserve to Optimize Acute Results and the Relationship to Long-Term Outcomes. JACC Cardiovasc Interv. 2016 May 23;9(10):1022-31. doi: 10.1016/j.jcin.2016.01.046.</citation>
    <PMID>27198682</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>June 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central Arkansas Veterans Healthcare System</investigator_affiliation>
    <investigator_full_name>Uretsky</investigator_full_name>
    <investigator_title>Director of Interventional Cardiology and Cath Lab</investigator_title>
  </responsible_party>
  <keyword>Fractional Flow Reserve</keyword>
  <keyword>Percutaneous Coronary Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03227588
org study id: 966635
nct id: NCT03227588
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The use of fractional flow reserve (FFR) has improved outcomes in percutaneous coronary
      interventions (PCI) in patients with symptomatic stable coronary artery disease (CAD) with
      intermediate angiographic stenoses. It is a clinical tool used routinely in cardiac
      catheterization laboratories throughout the world including the Little Rock VA Hospital. The
      technique utilizes a pressure transducer constructed as part of an 0.014" guidewire. An FFR
      of >0.80 has been linked with myocardial ischemia found with nuclear stress and dobutamine
      echo stress testing. The FAME trial clearly demonstrated its value in improving long-term
      outcomes as compared to use of angiography alone. As such, the use of FFR is incorporated
      into both AHA ACC and European PCI guideline recommendations as part of routine care for
      intermediate lesions. A "work horse" guide wire is so defined because it can be used in most
      PCI cases. It combines a low tip load (to avoid intimal dissection, with excellent (ideally,
      one to one) torque transmission and trackability through tortuous lesions. Recently the FDA
      has approved an FFR guide wire, OptoWire, (Opsens, Quebec City, Quebec, CAN) which uses light
      transmission to measure pressure rather than electrical transduction wires. The primary
      purpose of the present study is to determine how effective this wire is as a work horse wire
      in patients in whom FFR is required. The OptoWire may also have the advantage of less "drift"
      occurring during the procedure. Drift refers to the change in pressure due to issues related
      to the wire and measuring system, rather than a true change in pressure. All current FFR wire
      systems demonstrate some degree of drift requiring measuring pressure of the wire in the
      aorta after the procedure is completed to determine if, and to what extent, drift has
      occurred. Thus, a secondary aim of this study will determine the degree of drift.
EVALUATION OF THE OPSENS FRACTIONAL FLOW RESERVE (FFR) WIRE AS A "WORK HORSE" WIRE

      INVESTIGATORS:

      PRINCIPAL INVESTIGATOR: BARRY F URETSKY, MD CO-INVESTIGATOR: ABDUL HAKEEM, MD
      CO-INVESTIGATOR: MALEK AL-HAWWAS, MD

      Introduction The use of fractional flow reserve (FFR) has improved outcomes in percutaneous
      coronary interventions (PCI) in patients with symptomatic stable coronary artery disease
      (CAD) with intermediate angiographic stenoses. It is a clinical tool used routinely in
      cardiac catheterization laboratories throughout the world including the Little Rock VA
      hospital. The technique utilizes a pressure transducer constructed as part of an 0.014"
      guidewire. The wire is passed distal to the stenosis. Under the condition of maximal
      hyperemia induced by a drug, typically adenosine, the pressure proximal to the stenosis, i.e.
      aortic pressure or Pa and the pressure distal to the stenosis, Pd, are measured. The ratio,
      Pd/Pa, under maximal flow or hyperemia is known as the fractional flow reserve (FFR). An FFR
      of <0.80 has been correlated with observed myocardial ischemia using other diagnostic
      methods, particularly nuclear stress and dobutamine echo stress testing. The FAME trial
      clearly demonstrated its value in improving long-term outcomes as compared to use of
      angiography alone (1). As such, the use of FFR is incorporated into both AHA ACC and European
      PCI guideline recommendations as part of routine care for intermediate lesions (2,3).

      One of the limitations of the use of the FFR pressure wire itself is that its handling
      characteristics are somewhat inferior to a standard "work horse" guide wire used for PCI. A
      "work horse" guide wire is so defined because it can be used in most PCI cases. It combines a
      low tip load (to avoid intimal dissection) with excellent (ideally, one-to-one) torque
      transmission and trackability through tortuous lesions. There are several different work
      horse wires available. Although the wires may be different for different Cath Labs and
      operators, the wires are universally used to maximize safety, efficacy, and efficiency of
      PCI.

      In patients specifically requiring FFR to determine the value of PCI, it would be ideal if an
      FFR wire was as effective as a work horse wire so it could be used in difficult-to-traverse
      lesions. However, due to the complex electronics within current FFR wires, handling
      characteristics of previously used wires are inferior to current work horse wires. Recently
      the FDA has approved an FFR guide wire, OptoWire, (Opsens, Quebec City, Quebec, CAN) using
      light transmission to measure pressure rather than electrical transduction (4). It is
      commercially available in the United States. Its handling characteristics appear to approach
      that of a work horse guide wire and may represent an improvement over electrical transduction
      wires. The primary purpose of the present study is to determine how effective this wire is as
      a work horse wire in patients in whom FFR is required.

      The OptoWire may also have the advantage of less "drift" occuring during the procedure. Drift
      refers to the change in pressure due to issues related to the wire and measuring system,
      rather than a true change in pressure. All current FFR wire systems demonstrate some degree
      of drift requiring measuring pressure of the wire in the aorta after the procedure is
      completed to determine if, and to what extent, drift has occurred. Thus, a secondary aim of
      this study will determine the degree of drift.

      In clinical practice, FFR is performed before, and often after, PCI. In a study of 574
      patients treated at the Little Rock VA (IRB Study, #779601), teh investigators found that
      approximately 20% of angiographically optimized PCI still had an ischemic FFR. The
      investigators further found that this ischemic value could be improved by further treatments
      including balloon angioplasty and stenting. Thus, the secondary purpose is to measure FFR
      after successful PCI to ascertain the incidence of persistently ischemic FFR after optimized
      angiographic stenting to confirm the result from out previous study.

      Statistical analysis

      This study is descriptive. It will use means and standard deviation for continuous variables
      and prevalence or incidence in percentages as appropriate to show results. As there is no
      comparator group, comparative statistics will not be employed.

      Research aspect of study

      The research aspect of the study is limited to the systematic collection and analysis of data
      using the Opsens FFR wire with plan for publication. The other aspects of the study are
      considered part of routine clinical care. They include passage of FFR wire, measurement of
      FFR pre- and post-PCI, and performance of PCI itself.

      Significance of study

      A wire that can be used as a workhorse as well as be able to measure FFR would be of great
      value. The more effective and efficient is the FFR wire in not only measuring pre-PCI FFR but
      being able to be used for PCI and be stable and durable enough to be used for post-PCI
      optimization, the greater is the probability that this approach will be more generally
      adopted into clinical practice. Demonstration that the Opsens FFR wire is effective in this
      regard should further this goal.

      The investigators previously demonstrated that 21% or about 1 in 5 patients had an ischemic
      FFR after satisfactory angiographic result. This study will confirm previous results or
      suggest either an over- or under-estimation of that incidence.
observational model: Case-Only
time perspective: Prospective
measure: Opsens FFR Wire Performance
time frame: Acute result at end of procedure
description: Satisfactory performance is defined as the ability to perform the entire PCI plus measure FFR pre and post PCI with drift <0.05.
measure: Incidence of Ischemic or Low Non-ischemic FFR post PCI requiring further intervention
time frame: Acute result at end of procedure
intervention type: Diagnostic Test
intervention name: Fractional Flow Reserve
description: This is a prospective data collection study for patients that have undergone FFR.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
last name: Barry F. Uretsky, MD
role: Principal Investigator
affiliation: CAVHS
last name: Barry F. Uretsky, MD
phone: 501-257-1000
email: barry.uretsky@va.gov
last name: Kristin G Miller, RN, CCRC
phone: 501-257-5893
email: kristin.miller4@va.gov
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://opsensmedical.com/products/optowire/
description: Optowire product information
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.
PMID: 19144937
citation: Costa F, Ariotti S, Valgimigli M, Kolh P, Windecker S; Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Perspectives on the 2014 ESC/EACTS Guidelines on Myocardial Revascularization : Fifty Years of Revascularization: Where Are We and Where Are We Heading? J Cardiovasc Transl Res. 2015 Jun;8(4):211-20. doi: 10.1007/s12265-015-9632-6. Epub 2015 May 19.
PMID: 25986910
citation: Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011 Dec 6;58(24):e44-122. doi: 10.1016/j.jacc.2011.08.007. Epub 2011 Nov 7. No abstract available.
PMID: 22070834
citation: Agarwal SK, Kasula S, Hacioglu Y, Ahmed Z, Uretsky BF, Hakeem A. Utilizing Post-Intervention Fractional Flow Reserve to Optimize Acute Results and the Relationship to Long-Term Outcomes. JACC Cardiovasc Interv. 2016 May 23;9(10):1022-31. doi: 10.1016/j.jcin.2016.01.046.
PMID: 27198682
responsible party type: Principal Investigator
investigator affiliation: Central Arkansas Veterans Healthcare System
investigator full name: Uretsky
investigator title: Director of Interventional Cardiology and Cath Lab
mesh term: Coronary Artery Disease
sharing ipd: No