<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/NCT03027830</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03027830</nct_id>
  </id_info>
  <brief_title>iFR Pressure Wires in Assessment of the Provisional Side-branch Intervention Strategy for Bifurcation Lesions</brief_title>
  <official_title>Physiological and Clinical Assessment of the Provisional Side-branch Intervention Strategy for Coronary Bifurcation Lesions Using iFR Pressure Wires</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova-Med Medical Research Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova-Med Medical Research Association</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Even in the era of drug-eluting stents, bifurcation lesions remain one of the most&#xD;
      challenging lesion subsets in coronary intervention practice. This study was performed to&#xD;
      evaluate the functional outcomes of pressure wires (IFR)-guided jailed side-branch&#xD;
      intervention strategy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fractional flow reserve (FFR) measurements require minimal and constant microvascular&#xD;
      resistance which is routinely achieved by intravenous adenosine infusion. Adenosine-induced&#xD;
      hyperemia establishes an optimal vascular environment for FFR measurement. However,&#xD;
      breathlessness and chest tightness are common adverse events during adenosine infusion and&#xD;
      severe asthma occurs occasionally. The Introduction of an adenosine-independent index&#xD;
      (instantaneous wave-free ratio [iFR]) into clinical practice offered easier and&#xD;
      hyperemia-free method for lesion assessment.&#xD;
&#xD;
      Physiological changes and clinical evaluation of iFR warrants further research. Therefore,&#xD;
      the investigators conducted this study to evaluate the functional aspects of iFR-guided&#xD;
      provisional jailed side-branch intervention strategy and compare clinical endpoints to&#xD;
      conventional non-iFR-guided operations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physiological evaluation of iFR-guided intervention</measure>
    <time_frame>6-month</time_frame>
    <description>iFR changes after drug-eluting balloon (DEB) inflation of the jailed side branch.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>6-month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>30-day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>30-day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital heart failure class</measure>
    <time_frame>30-day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-month heart failure class</measure>
    <time_frame>6-month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-PCI angina</measure>
    <time_frame>6-month</time_frame>
    <description>Comparison of the incidence of angina after performing PCI in both the iFR and conventional groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ejection fraction at 6 months' post operation</measure>
    <time_frame>6-month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The amount of dye injection for angiography</measure>
    <time_frame>30-day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Coronary Bifurcation Lesions</condition>
  <arm_group>
    <arm_group_label>iFR pressure-wire</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iFR pressure-wire</intervention_name>
    <description>The instantaneous wave-free ratio (iFR) as an adenosine-independent index of coronary stenosis severity, calculated as the ratio between the distal trans-stenotic pressure and the proximal coronary pressure during a specific diastolic wave-free period</description>
    <arm_group_label>iFR pressure-wire</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional</intervention_name>
    <description>Other diagnostic devices (including FFR and angiography)</description>
    <arm_group_label>Conventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute coronary syndrome&#xD;
&#xD;
          -  Jailed side-branch of a vessel size &gt; 2 mm&#xD;
&#xD;
          -  Vessel length &gt; 40 mm&#xD;
&#xD;
          -  Lesion length &lt; 10 mm by visual estimation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant stenosis in the left main coronary artery or the main branch proximal to&#xD;
             the stented segment&#xD;
&#xD;
          -  Totally occluded bifurcation lesions&#xD;
&#xD;
          -  Primary myocardial disease&#xD;
&#xD;
          -  Serum creatinine level of ≥ 2.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Provisional side-branch intervention strategy</keyword>
  <keyword>iFR</keyword>
  <keyword>Pilot study</keyword>
  <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/NCT03027830
org study id: 1
nct id: NCT03027830
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Even in the era of drug-eluting stents, bifurcation lesions remain one of the most
      challenging lesion subsets in coronary intervention practice. This study was performed to
      evaluate the functional outcomes of pressure wires (IFR)-guided jailed side-branch
      intervention strategy.
Fractional flow reserve (FFR) measurements require minimal and constant microvascular
      resistance which is routinely achieved by intravenous adenosine infusion. Adenosine-induced
      hyperemia establishes an optimal vascular environment for FFR measurement. However,
      breathlessness and chest tightness are common adverse events during adenosine infusion and
      severe asthma occurs occasionally. The Introduction of an adenosine-independent index
      (instantaneous wave-free ratio [iFR]) into clinical practice offered easier and
      hyperemia-free method for lesion assessment.

      Physiological changes and clinical evaluation of iFR warrants further research. Therefore,
      the investigators conducted this study to evaluate the functional aspects of iFR-guided
      provisional jailed side-branch intervention strategy and compare clinical endpoints to
      conventional non-iFR-guided operations.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Physiological evaluation of iFR-guided intervention
time frame: 6-month
description: iFR changes after drug-eluting balloon (DEB) inflation of the jailed side branch.
measure: length of hospital stay
time frame: 6-month
measure: Procedure time
time frame: 30-day
measure: Fluoroscopy time
time frame: 30-day
measure: In-hospital heart failure class
time frame: 30-day
measure: 6-month heart failure class
time frame: 6-month
measure: Post-PCI angina
time frame: 6-month
description: Comparison of the incidence of angina after performing PCI in both the iFR and conventional groups
measure: Ejection fraction at 6 months' post operation
time frame: 6-month
measure: The amount of dye injection for angiography
time frame: 30-day
arm group label: iFR pressure-wire
arm group type: Experimental
arm group label: Conventional
arm group type: Active Comparator
intervention type: Device
intervention name: iFR pressure-wire
description: The instantaneous wave-free ratio (iFR) as an adenosine-independent index of coronary stenosis severity, calculated as the ratio between the distal trans-stenotic pressure and the proximal coronary pressure during a specific diastolic wave-free period
arm group label: iFR pressure-wire
intervention type: Device
intervention name: Conventional
description: Other diagnostic devices (including FFR and angiography)
arm group label: Conventional
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
sharing ipd: No