<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/NCT03237169</url>
  </required_header>
  <id_info>
    <org_study_id>2017-02</org_study_id>
    <nct_id>NCT03237169</nct_id>
  </id_info>
  <brief_title>Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR</brief_title>
  <acronym>PREDICT</acronym>
  <official_title>Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Hospitalar Lisboa Ocidental</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cardiovascular Research Foundation, New York</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centro Hospitalar Lisboa Ocidental</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>
      To test the feasibility and diagnostic accuracy of a new automated pressure derived resting&#xD;
      index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive&#xD;
      physiological evaluation is warranted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary lesions with a potential indication for percutaneous coronary intervention or&#xD;
      warranting invasive physiological interrogation (in the opinion of the investigator) will&#xD;
      undergo PressureWire™ assessment under 2 conditions: rest and adenosine hyperemia. The&#xD;
      measurements at rest (standard Pd/Pa and Pd/Pamin) will be repeated to assess test/retest&#xD;
      repeatability. Subsequent treatment decisions will be made by the operator according to the&#xD;
      standard practice based on the adenosine FFR value together with all other clinical&#xD;
      information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 28, 2016</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy of Pd/Pamin vs FFR</measure>
    <time_frame>baseline</time_frame>
    <description>Agreement will be tested using the established FFR 0.8 threshold as the binary reference standard.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Discriminative power of Pd/Pamin and the best cut-off, taking FFR as gold</measure>
    <time_frame>baseline</time_frame>
    <description>ROC analysis using FFR as reference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of Pd/Pamin measurements</measure>
    <time_frame>Baseline</time_frame>
    <description>Description of how often can Pd/Pamin can be measured accurately</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Fractional Flow Reserve, Myocardial</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Prospective cohort</arm_group_label>
    <description>Prospective cohort of patients with stable or stabilized coronary artery disease and de novo coronary lesions, in whom functional evaluation is performed, according do standard clinical indications.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive subjects scheduled for coronary angiography or PCI in whom operator decides to&#xD;
        perform FFR will be approached for enrollment. Being a first-in-man study of a novel&#xD;
        pressure index intended for future validation and use in a clinical setting, a full&#xD;
        assessment of its range throughout the entire spectrum of lesion severity is warranted. As&#xD;
        such, the protocol will allow for the inclusion of both less severe as well as of critical&#xD;
        (&gt;90%) lesions. Patients with either single or multiple vessel disease will be included.&#xD;
&#xD;
        Data on additional lesions may or may not be collected but will not be used in the study.&#xD;
        Vessels with sequential stenosis and tandem lesions will be evaluated and treated according&#xD;
        to routine clinical practice, but not included in the study data collected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing FFR assessment for standard clinical indications, according to&#xD;
             individual operator decision.&#xD;
&#xD;
          2. Age ≥ 18 years.&#xD;
&#xD;
          3. Provided signed written informed consent for data collection the collection.&#xD;
&#xD;
          4. De novo coronary artery disease in target vessel.&#xD;
&#xD;
          5. Single or multiple vessel disease.&#xD;
&#xD;
          6. Patient eligible for elective or ad hoc PCI (or CABG), if revascularization is deemed&#xD;
             indicated, in the setting of stable coronary artery disease or non-culprit lesions of&#xD;
             non-ST elevation acute coronary syndromes (only in deferred procedures).&#xD;
&#xD;
          7. Stenosis deemed amenable for both evaluation with a pressure wire and for potential&#xD;
             revascularization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with restenosis in the target vessel.&#xD;
&#xD;
          2. Known severe renal insufficiency (examples being but not limited to eGFR &lt;30&#xD;
             ml/kg/min, serum creatinine ≥ 2.5 mg/dL or on dialysis).&#xD;
&#xD;
          3. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).&#xD;
&#xD;
          4. Vessel(s) and lesion(s) not amenable for evaluation with a PressureWire™ and/or&#xD;
             revascularization.&#xD;
&#xD;
          5. Tandem lesions&#xD;
&#xD;
          6. Moderate lesions in patients with multivessel disease in whom at least one lesion in&#xD;
             another major epicardic vessel is severe (to minimize lesion interaction), unless the&#xD;
             severe lesion is treated first (see above).&#xD;
&#xD;
          7. Left ventricular ejection fraction &lt;50%&#xD;
&#xD;
          8. Known severe left ventricular hypertrophy&#xD;
&#xD;
          9. Atrial fibrillation or any other significant arrhythmia (including an heart rate&#xD;
             &lt;50/min on sinus rhythm)&#xD;
&#xD;
         10. Systolic blood pressure &lt;90 mmHg.&#xD;
&#xD;
         11. Any other medical condition that in the opinion of the investigator will interfere&#xD;
             with patient safety or study results&#xD;
&#xD;
         12. Currently participating in another clinical study that interferes with study results.&#xD;
&#xD;
         13. Pregnant or nursing females&#xD;
&#xD;
         14. Planned or prior heart transplantation or listed for heart transplant.&#xD;
&#xD;
         15. Any condition that precludes the subject from undergoing PCI or any of the protocol&#xD;
             mandated procedures, for example subjects with a prior history heparin induced&#xD;
             thrombocytopenia, known intolerance to adenosine or with a contra-indication for dual&#xD;
             anti-platelet therapy.&#xD;
&#xD;
         16. Patients with severe valvular disease&#xD;
&#xD;
         17. Patients with severe pulmonary disease&#xD;
&#xD;
         18. Culprit lesions in ACS patients are not to be included nor non-culprit lesions in&#xD;
             patients with a recent STEMI undergoing staged procedures.&#xD;
&#xD;
         19. Patients with a CTO, regardless of the presence and the extent of angiographic&#xD;
             collaterals from the target vessel.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis Raposo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centro Hospitalar de Lisboa Ocidental</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sergio Bravo Baptista, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Fernando da Fonseca</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Luis Raposo, MD</last_name>
    <phone>+351962933777</phone>
    <email>lfor.md@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>St. Francis Hospital The Heart Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>11576</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Allen Jeremias, MD</last_name>
      <phone>516-390-9640</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Cardiology, University Hospital</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric VanBelle, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institute of Cardiology, Catholic University of the Sacred Heart</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio M Leone, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Prof. Doutor Fernando da Fonseca</name>
      <address>
        <city>Amadora</city>
        <zip>2720-276</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sergio B Batista, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz</name>
      <address>
        <city>Carnaxide</city>
        <zip>2790-134</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis Raposo, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Lisboa Central (CHLC) - Hospital de Santa Marta</name>
      <address>
        <city>Lisboa</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruben Ramos, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
    <country>Italy</country>
    <country>Portugal</country>
    <country>United States</country>
  </location_countries>
  <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>Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI); Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010 Oct;31(20):2501-55. doi: 10.1093/eurheartj/ehq277. Epub 2010 Aug 29. No abstract available.</citation>
    <PMID>20802248</PMID>
  </reference>
  <reference>
    <citation>Mamas MA, Horner S, Welch E, Ashworth A, Millington S, Fraser D, Fath-Ordoubadi F, Neyses L, El-Omar M. Resting Pd/Pa measured with intracoronary pressure wire strongly predicts fractional flow reserve. J Invasive Cardiol. 2010 Jun;22(6):260-5.</citation>
    <PMID>20516504</PMID>
  </reference>
  <reference>
    <citation>Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7.</citation>
    <PMID>22154731</PMID>
  </reference>
  <reference>
    <citation>Ganz P, Abben R, Friedman PL, Garnic JD, Barry WH, Levin DC. Usefulness of transstenotic coronary pressure gradient measurements during diagnostic catheterization. Am J Cardiol. 1985 Apr 1;55(8):910-4. doi: 10.1016/0002-9149(85)90716-7.</citation>
    <PMID>3157307</PMID>
  </reference>
  <reference>
    <citation>Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979 Jul 12;301(2):61-8. doi: 10.1056/NEJM197907123010201.</citation>
    <PMID>449946</PMID>
  </reference>
  <reference>
    <citation>Berry C, van 't Veer M, Witt N, Kala P, Bocek O, Pyxaras SA, McClure JD, Fearon WF, Barbato E, Tonino PA, De Bruyne B, Pijls NH, Oldroyd KG. VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice): a multicenter study in consecutive patients. J Am Coll Cardiol. 2013 Apr 2;61(13):1421-7. doi: 10.1016/j.jacc.2012.09.065. Epub 2013 Feb 6.</citation>
    <PMID>23395076</PMID>
  </reference>
  <reference>
    <citation>Ganz P, Harrington DP, Gaspar J, Barry WH. Phasic pressure gradients across coronary and renal artery stenoses in humans. Am Heart J. 1983 Dec;106(6):1399-406. doi: 10.1016/0002-8703(83)90052-2.</citation>
    <PMID>6650363</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>May 9, 2018</last_update_submitted>
  <last_update_submitted_qc>May 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Hospitalar Lisboa Ocidental</investigator_affiliation>
    <investigator_full_name>Luis Raposo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT03237169
org study id: 2017-02
nct id: NCT03237169
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To test the feasibility and diagnostic accuracy of a new automated pressure derived resting
      index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive
      physiological evaluation is warranted.
Coronary lesions with a potential indication for percutaneous coronary intervention or
      warranting invasive physiological interrogation (in the opinion of the investigator) will
      undergo PressureWire™ assessment under 2 conditions: rest and adenosine hyperemia. The
      measurements at rest (standard Pd/Pa and Pd/Pamin) will be repeated to assess test/retest
      repeatability. Subsequent treatment decisions will be made by the operator according to the
      standard practice based on the adenosine FFR value together with all other clinical
      information.
observational model: Cohort
time perspective: Prospective
measure: Diagnostic accuracy of Pd/Pamin vs FFR
time frame: baseline
description: Agreement will be tested using the established FFR 0.8 threshold as the binary reference standard.
measure: Discriminative power of Pd/Pamin and the best cut-off, taking FFR as gold
time frame: baseline
description: ROC analysis using FFR as reference
measure: Feasibility of Pd/Pamin measurements
time frame: Baseline
description: Description of how often can Pd/Pamin can be measured accurately
arm group label: Prospective cohort
description: Prospective cohort of patients with stable or stabilized coronary artery disease and de novo coronary lesions, in whom functional evaluation is performed, according do standard clinical indications.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luis Raposo, MD
role: Principal Investigator
affiliation: Centro Hospitalar de Lisboa Ocidental
last name: Sergio Bravo Baptista, MD, PhD
role: Study Chair
affiliation: Hospital Fernando da Fonseca
last name: Luis Raposo, MD
phone: +351962933777
email: lfor.md@gmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
country: Italy
country: Portugal
country: United States
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: Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI); Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010 Oct;31(20):2501-55. doi: 10.1093/eurheartj/ehq277. Epub 2010 Aug 29. No abstract available.
PMID: 20802248
citation: Mamas MA, Horner S, Welch E, Ashworth A, Millington S, Fraser D, Fath-Ordoubadi F, Neyses L, El-Omar M. Resting Pd/Pa measured with intracoronary pressure wire strongly predicts fractional flow reserve. J Invasive Cardiol. 2010 Jun;22(6):260-5.
PMID: 20516504
citation: Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7.
PMID: 22154731
citation: Ganz P, Abben R, Friedman PL, Garnic JD, Barry WH, Levin DC. Usefulness of transstenotic coronary pressure gradient measurements during diagnostic catheterization. Am J Cardiol. 1985 Apr 1;55(8):910-4. doi: 10.1016/0002-9149(85)90716-7.
PMID: 3157307
citation: Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979 Jul 12;301(2):61-8. doi: 10.1056/NEJM197907123010201.
PMID: 449946
citation: Berry C, van 't Veer M, Witt N, Kala P, Bocek O, Pyxaras SA, McClure JD, Fearon WF, Barbato E, Tonino PA, De Bruyne B, Pijls NH, Oldroyd KG. VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice): a multicenter study in consecutive patients. J Am Coll Cardiol. 2013 Apr 2;61(13):1421-7. doi: 10.1016/j.jacc.2012.09.065. Epub 2013 Feb 6.
PMID: 23395076
citation: Ganz P, Harrington DP, Gaspar J, Barry WH. Phasic pressure gradients across coronary and renal artery stenoses in humans. Am Heart J. 1983 Dec;106(6):1399-406. doi: 10.1016/0002-8703(83)90052-2.
PMID: 6650363
responsible party type: Principal Investigator
investigator affiliation: Centro Hospitalar Lisboa Ocidental
investigator full name: Luis Raposo
investigator title: Principal Investigator
mesh term: Coronary Artery Disease
sharing ipd: No