<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/NCT04494750</url>
  </required_header>
  <id_info>
    <org_study_id>EASY-PRIPCI</org_study_id>
    <nct_id>NCT04494750</nct_id>
  </id_info>
  <brief_title>Physiology and Residual Ischemia After Percutaneous Coronary Intervention</brief_title>
  <acronym>EASY-PRIPCI</acronym>
  <official_title>Physiology and Residual Ischemia After Percutaneous Coronary Intervention (EArly Discharge After Transradial Stenting of CoronarY Arteries- EASY- PRIPCI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quebec Heart Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Laval University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite optimal angiographic result after stent implantation, a number of patients will&#xD;
      undergo repeat angiography within 1 year of index procedure. EASY-PRIPCI is an observational&#xD;
      study evaluating the incidence of abnormal physiology results in patients undergoing repeat&#xD;
      angiography after uncomplicated percutaneous intervention (PCI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite successful PCI and complete revascularization, about 25% of patients will present&#xD;
      with angina and/or positive exercise testing during follow-up. With recurring or persistent&#xD;
      symptoms, a number of those patients will be referred for control angiography. This might&#xD;
      create a significant burden for health systems as well as putting patients to undergo further&#xD;
      interventions without clear demonstration of ischemia.&#xD;
&#xD;
      Assessing physiology and fractional flow reserve in particular after PCI could represent a&#xD;
      further step to determine whether stent implantation and stenosis removal will be effective&#xD;
      to relieve subjective and objective signs of ischemia.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Resting gradients such as whole cycle Pd/Pa and diastolic dPR and FFR will be abnormal (below&#xD;
      ischemic threshold) in &gt; 20% of cases despite optimal stent implantation and angiographic&#xD;
      result.&#xD;
&#xD;
      The use of physiology assessment in previously intervened vessels in patients referred for&#xD;
      persisting or recurring angina might help operators to decide upon further intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 18, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of successful uncomplicated PCI as per coronary physiology ratios</measure>
    <time_frame>Transprocedural, initial and final values</time_frame>
    <description>Record the minimal values reported for Pd/Pa, dPR and FFR ratios in the distal vessel after uncomplicated PCI and good angiographic result.Comparison between baseline (pre PCI) and final (post PCI) coronary physiology ratios .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and types of further interventions or imaging techniques</measure>
    <time_frame>Historical and immediately after the procedure, up to 36 months</time_frame>
    <description>Record the incidence by type of intervention and diagnostic or imaging techniques</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual symptoms and quality of life after repeat angiography</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Identify residual symptoms after intervention, and overall immediate quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of repeat interventions</measure>
    <time_frame>Historical and immediately after the procedure</time_frame>
    <description>on previously intervened lesions versus PCI on new lesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of successful distal positioning of pressurewire</measure>
    <time_frame>Transprocedural</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <condition>Angina Pectoris</condition>
  <condition>Chest Pain</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Coronary Restenosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients returning to the Quebec Heart Institute for a diagnostic angiography and possible&#xD;
        PCI within 12 months of a previous uncomplicated PCI with stent implantation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient referred for diagnostic angiography and possible PCI within 12 months of&#xD;
             uncomplicated PCI with stent implantation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to understand study design or objectives of study.&#xD;
&#xD;
          -  Unable to sign informed consent.&#xD;
&#xD;
          -  Evidence of in-stent restenosis or significant untreated coronary lesions (initial&#xD;
             incomplete revascularization)&#xD;
&#xD;
          -  Inability to comply with the study follow-up&#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>Olivier F. Bertrand, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Laval University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Olivier F. Bertrand, MD, PhD</last_name>
    <phone>+14186568711</phone>
    <phone_ext>5947</phone_ext>
    <email>olivier.bertrand@chul.ulaval.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>IUCPQ - Laval Hospital</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier F Bertrand, MD PhD</last_name>
      <phone>418 656 8711</phone>
      <email>olivier.bertrand@crhl.ulaval.ca</email>
    </contact>
    <investigator>
      <last_name>Olivier F Bertrand, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tomas Cieza, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>January 28, 2022</last_update_submitted>
  <last_update_submitted_qc>January 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Olivier F. Bertrand</investigator_full_name>
    <investigator_title>Director of the International Chair of Interventional Cardiology and Transradial Approach</investigator_title>
  </responsible_party>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Fractional Flow Reserve (FFR)</keyword>
  <keyword>Coronary physiology</keyword>
  <keyword>Repeat intervention</keyword>
  <keyword>diastolic pressure ratio (dPR)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Coronary Restenosis</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Chest Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT04494750
org study id: EASY-PRIPCI
nct id: NCT04494750
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Despite optimal angiographic result after stent implantation, a number of patients will
      undergo repeat angiography within 1 year of index procedure. EASY-PRIPCI is an observational
      study evaluating the incidence of abnormal physiology results in patients undergoing repeat
      angiography after uncomplicated percutaneous intervention (PCI).
Despite successful PCI and complete revascularization, about 25% of patients will present
      with angina and/or positive exercise testing during follow-up. With recurring or persistent
      symptoms, a number of those patients will be referred for control angiography. This might
      create a significant burden for health systems as well as putting patients to undergo further
      interventions without clear demonstration of ischemia.

      Assessing physiology and fractional flow reserve in particular after PCI could represent a
      further step to determine whether stent implantation and stenosis removal will be effective
      to relieve subjective and objective signs of ischemia.

      Hypothesis:

      Resting gradients such as whole cycle Pd/Pa and diastolic dPR and FFR will be abnormal (below
      ischemic threshold) in > 20% of cases despite optimal stent implantation and angiographic
      result.

      The use of physiology assessment in previously intervened vessels in patients referred for
      persisting or recurring angina might help operators to decide upon further intervention.
observational model: Case-Crossover
time perspective: Cross-Sectional
measure: Rate of successful uncomplicated PCI as per coronary physiology ratios
time frame: Transprocedural, initial and final values
description: Record the minimal values reported for Pd/Pa, dPR and FFR ratios in the distal vessel after uncomplicated PCI and good angiographic result.Comparison between baseline (pre PCI) and final (post PCI) coronary physiology ratios .
measure: Incidence and types of further interventions or imaging techniques
time frame: Historical and immediately after the procedure, up to 36 months
description: Record the incidence by type of intervention and diagnostic or imaging techniques
measure: Residual symptoms and quality of life after repeat angiography
time frame: up to 30 days
description: Identify residual symptoms after intervention, and overall immediate quality of life.
measure: Rates of repeat interventions
time frame: Historical and immediately after the procedure
description: on previously intervened lesions versus PCI on new lesions
measure: Incidence of successful distal positioning of pressurewire
time frame: Transprocedural
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier F. Bertrand, MD, PhD
role: Principal Investigator
affiliation: Laval University
last name: Olivier F. Bertrand, MD, PhD
phone: +14186568711
phone ext: 5947
email: olivier.bertrand@chul.ulaval.ca
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Olivier F. Bertrand
investigator title: Director of the International Chair of Interventional Cardiology and Transradial Approach
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Heart Diseases
mesh term: Angina Pectoris
mesh term: Coronary Restenosis
mesh term: Ischemia
mesh term: Chest Pain