<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/NCT03259815</url>
  </required_header>
  <id_info>
    <org_study_id>17/CARD/10</org_study_id>
    <secondary_id>IRAS ID 223780</secondary_id>
    <nct_id>NCT03259815</nct_id>
  </id_info>
  <brief_title>An Evaluation of a Physiology-guided PCI Optimisation Strategy</brief_title>
  <acronym>Target-FFR</acronym>
  <official_title>How Often Can Optimal Post Percutaneous Coronary Intervention (PCI) Fractional Flow Reserve (FFR) Results be Achieved? - a Randomised Controlled Trial of FFR Targeted PCI (the Target FFR Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS National Waiting Times Centre Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NHS National Waiting Times Centre Board</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>
      There has recently been renewed interest in the measurement of post percutaneous coronary&#xD;
      intervention (PCI) Fractional Flow Reserve (FFR). Previous studies have suggested that&#xD;
      post-PCI FFR values ≥0.90 are associated with better clinical outcomes for patients but the&#xD;
      available data suggest that despite angiographically satisfactory results, this is actually&#xD;
      achieved in less than 40% of cases.&#xD;
&#xD;
      The main mechanisms for sub-optimal post-PCI FFR measurements have been proposed to be&#xD;
      suboptimal stent deployment, unmasking of a second lesion in the target vessel post PCI,&#xD;
      residual diffuse disease in the untreated segments and pressure drift (a technical artefact&#xD;
      of pressure wire technology).&#xD;
&#xD;
      Using post-PCI FFR to guide stent optimisation and/or further intervention in the target&#xD;
      vessel has been shown to increase the frequency of achieving optimal post-PCI FFR results&#xD;
      (and therefore presumably better clinical outcomes). However, there are additional costs&#xD;
      involved in the routine use of post-PCI FFR and it is not clear just how often it is even&#xD;
      possible to increase the initial post-PCI FFR to ≥0.90. This uncertainty means that it is&#xD;
      currently difficult to either recommend the routine use of post-PCI FFR or justify its cost.&#xD;
&#xD;
      The investigators propose a prospective study to assess the feasibility of achieving post-PCI&#xD;
      FFR ≥0.90 during standard PCI procedures in consecutive patients. The study would also&#xD;
      attempt to elucidate the mechanisms for sub-optimal FFR results when they occur. The&#xD;
      investigators anticipate using the data from this developmental study to support a subsequent&#xD;
      funding application for a definitive phase 3 study of the impact of FFR targeted PCI on&#xD;
      clinical outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Original hypothesis&#xD;
&#xD;
      A simple Physiology-guided Incremental Optimisation Strategy (PIOS) can increase the&#xD;
      proportion of patients undergoing PCI in whom a post-PCI FFR ≥0.90 can be achieved from 40%&#xD;
      to 60%.&#xD;
&#xD;
      Experimental details and design of proposed investigation&#xD;
&#xD;
      Overall aim:&#xD;
&#xD;
      A randomised controlled trial of a physiology-guided optimisation strategy to determine the&#xD;
      feasibility of increasing the proportion of post-PCI FFR measurements ≥0.90 in a consecutive&#xD;
      series of patients undergoing standard PCI procedures.&#xD;
&#xD;
      Study Population:&#xD;
&#xD;
      260 consecutive patients with stable angina referred for invasive management to the cardiac&#xD;
      catheterisation lab who have been selected to undergo PCI based on either angiographic&#xD;
      appearances or prior FFR assessment. Patients will be caffeine free for &gt;12 hours&#xD;
      pre-procedure.&#xD;
&#xD;
      Methods/Design:&#xD;
&#xD;
      Informed consent will be obtained prior to cardiac catheterisation in all potential subjects&#xD;
      conforming to the inclusion and exclusion criteria.&#xD;
&#xD;
      Patients will then be randomised to one of two groups (described below) and PCI will be&#xD;
      performed, using a pressure guidewire, according to standard practice at the Golden Jubilee&#xD;
      National Hospital (including lesion pre-dilation and post-dilation of the stented segment).&#xD;
&#xD;
      Group 1 (PIOS Group):&#xD;
&#xD;
      Operator-blinded coronary physiology measurements will be recorded pre and post PCI.&#xD;
&#xD;
      If the post-PCI FFR is ≥0.90, no further intervention will be performed and the procedure is&#xD;
      considered complete.&#xD;
&#xD;
      If post-PCI FFR is &lt;0.90, the result will be disclosed to the operator and a hyperaemic&#xD;
      pressure wire pullback during a standard peripheral intravenous adenosine infusion&#xD;
      (140mcg/kg/min) will be performed. Depending on the result the operator would then have the&#xD;
      following options:&#xD;
&#xD;
      A. If there is a step-up of ≥0.05 across the stented segment(s) further post-dilatation with&#xD;
      a 0.25 - 0.50mm larger non-compliant balloon to at least 18 atmospheres should be performed&#xD;
      followed by repeat FFR. Alternatively, the operator may choose to employ intracoronary&#xD;
      imaging (IVUS or OCT) to guide post-dilation/optimisation of the stented segment.&#xD;
&#xD;
      B. If there is a step-up of ≥0.05 across a relatively focal (&lt;20mm) unstented segment which&#xD;
      is technically suitable for further stenting then a further stent should be implanted&#xD;
      followed by repeat FFR.&#xD;
&#xD;
      C. If the FFR remains &lt;0.90 after steps A +/- B, a further FFR pullback will be performed. If&#xD;
      the criteria for Step B are again met, one additional stent may be deployed and a final FFR&#xD;
      pullback performed. Following this, the FFR result will be accepted.&#xD;
&#xD;
      D. If the residual pressure gradient is interpreted to reflect diffuse atherosclerosis with&#xD;
      no focal step-ups, the result is accepted.&#xD;
&#xD;
      E. At the end of the procedure the pressure wire sensor will be withdrawn to the tip of the&#xD;
      guiding catheter and compared with the aortic pressure. A pressure drift of ≤0.03 will be&#xD;
      accepted and the final FFR result adjusted accordingly.&#xD;
&#xD;
      F. If there is a drift of ≥0.04, the wire should be re-equalised and the final FFR&#xD;
      measurement be repeated.&#xD;
&#xD;
      G. The patients will have their demographics and procedure details recorded. All patients&#xD;
      will be asked to complete follow-up questionnaires at 3 months.&#xD;
&#xD;
      Group 2 (Control Group):&#xD;
&#xD;
      Pre and post-PCI coronary physiology measurements will be recorded but not disclosed to the&#xD;
      operator. The angiographically defined result will be accepted. The patients will have their&#xD;
      demographics and procedure details recorded. All patients will be asked to complete follow-up&#xD;
      questionnaires at 3 months.&#xD;
&#xD;
      Expected value of results&#xD;
&#xD;
        1. Confirmation that the proposed PIOS protocol significantly increases the proportion of&#xD;
           patients obtaining a physiologically optimal post-PCI result will demonstrate the&#xD;
           feasibility of this strategy and should lead to an increase in post-PCI pressure wire&#xD;
           usage to achieve physiologically optimal results for patients.&#xD;
&#xD;
           The investigators hypothesise that the PIOS intervention can increase the proportion of&#xD;
           patients achieving this target from 40% to 60% and believe that an increment of at least&#xD;
           this magnitude would be necessary to make a future larger study with both&#xD;
           patient-oriented clinical (target vessel failure) and health care system (resource&#xD;
           utilisation) outcomes acceptable to the interventional cardiology community and&#xD;
           potential funders.&#xD;
&#xD;
        2. The secondary outcome measures, albeit underpowered for clinical outcomes in this study,&#xD;
           will hopefully still give a signal that achieving a target post-PCI FFR ≥0.90 does yield&#xD;
           objective benefits for patients. This could then form the basis for a larger phase 3&#xD;
           trial to confirm improved clinical outcomes and cost- effectiveness of FFR-targeted PCI&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2018</start_date>
  <completion_date type="Actual">December 4, 2020</completion_date>
  <primary_completion_date type="Actual">November 22, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomised Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>Operator blinded pre and post PCI coronary physiology measurements will be performed in both arms of the study.&#xD;
Post-PCI FFR results &lt;0.90 in the interventional arm will be disclosed to the operator to allow further intervention</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of patients with a final post-PCI FFR result ≥0.90</measure>
    <time_frame>1 day</time_frame>
    <description>The proportion of patients with a final post-PCI FFR result ≥0.90 will be compared between the randomised groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients with final post-PCI FFR ≤0.80</measure>
    <time_frame>1 day</time_frame>
    <description>The proportion of patients with a final post-PCI FFR result ≤0.80 will be compared between the randomised groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in self-reported health outcomes at 3 months using a disease-specific quality of life measurement tool.</measure>
    <time_frame>3 months</time_frame>
    <description>Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline pre-procedure and again at 3 months post PCI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in self-reported health outcomes at 3 months using a generic quality of life measurement tool.</measure>
    <time_frame>3 months</time_frame>
    <description>Patients will complete the EQ-5D questionnaire at baseline pre-procedure and again at 3 months post PCI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of target vessel failure (TVF) and its component features at 3 months.</measure>
    <time_frame>3 months</time_frame>
    <description>Component features of TVF include cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalisation with target vessel revascularisation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of target vessel failure (TVF) and its component features at 1 year.</measure>
    <time_frame>1 year</time_frame>
    <description>Component features of TVF include cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalisation with target vessel revascularisation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the FFR following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>The difference between measurements of Fractional Flow Reserve taken in the target vessel pre- and post-PCI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients with final post-PCI dPR ≥0.90</measure>
    <time_frame>1 day</time_frame>
    <description>The proportion of patients with a final post-PCI Diastolic Pressure Ratio (dPR) value ≥0.90</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Diastolic Pressure Ratio (dPR) following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>The difference between measurements of the Diastolic Pressure Ratio taken in the target vessel pre and post PCI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients with final post-PCI RFR ≥0.90</measure>
    <time_frame>1 day</time_frame>
    <description>The proportion of patients with a final post-PCI Resting Full-cycle Ratio (RFR) value ≥0.90</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Resting Full-Cycle Ratio (RFR) following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>The difference between measurements of the Resting Full-Cycle Ratio (the lowest Pd/Pa ratio during the whole cardiac cycle at rest) taken in the target vessel pre and post PCI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in TTrest following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>Change of the thermodilution-derived resting transit time (TTrest) from pre-PCI to final post-PCI value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in TThyp following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>Change of the thermodilution-derived hyperaemic transit time (TThyp) from pre-PCI to final post-PCI value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients with final post-PCI CFR value ≥2.0</measure>
    <time_frame>1 day</time_frame>
    <description>The proportion of patients with a final post-PCI Coronary Flow Reserve (CFR) result ≥2.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Coronary Flow Reserve (CFR) following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>The difference between measurements of Coronary Flow Reserve taken in the target vessel pre and post PCI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients with final post-PCI IMR &gt;25</measure>
    <time_frame>1 day</time_frame>
    <description>The proportion of patients with a final post-PCI Index of Microcirculatory Resistance (IMR) value &gt;25</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the Index of Microcirculatory Resistance (IMR) following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>The difference between measurements of IMR taken in the target vessel pre and post PCI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients with final post-PCI IMRc &gt;25</measure>
    <time_frame>1 day</time_frame>
    <description>The proportion of patients with a final post-PCI corrected Index of Microcirculatory Resistance (IMRc) value &gt;25</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Duration</measure>
    <time_frame>1 day</time_frame>
    <description>The time required to perform the PIOS intervention procedures will be compared with those in the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The cost of additional equipment employed in the experimental arm</measure>
    <time_frame>1 day</time_frame>
    <description>The cost of additional equipment employed in the PIOS intervention (i.e. balloons/stents/intra-coronary imaging).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy Dose</measure>
    <time_frame>1 day</time_frame>
    <description>The radiation doses for the PIOS intervention procedures will be compared with those in the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast Material Dose</measure>
    <time_frame>1 day</time_frame>
    <description>The contrast material doses for the PIOS intervention procedures will be compared with those in the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of procedural complications such as coronary artery dissection or perforation.</measure>
    <time_frame>1 day</time_frame>
    <description>The incidence of procedural complications such as coronary artery dissection or perforation will be recorded and compared between the two study arms</description>
  </secondary_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the proportion of patients with a final post-PCI FFR result ≥0.90</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the proportion of patients with final post-PCI FFR ≤0.80</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the change from baseline in self-reported health outcomes at 3 months as assessed by the Seattle Angina Questionnaire (SAQ)</measure>
    <time_frame>3 months</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the change from baseline in self-reported health outcomes at 3 months as assessed by the EQ-5D questionnaire.</measure>
    <time_frame>3 months</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the rate of target vessel failure (TVF) and its component features at 3 months.</measure>
    <time_frame>3 months</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the rate of target vessel failure (TVF) and its component features at 1 year.</measure>
    <time_frame>1 year</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the change from baseline in the FFR following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the proportion of patients with final post-PCI dPR ≥0.90</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the change from baseline in the dPR following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the proportion of patients with final post-PCI RFR ≥0.90</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the change from baseline in the RFR following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the change in TTrest following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the change in TThyp following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the proportion of patients with final post-PCI CFR value ≥2.0</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the change from baseline in the CFR following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the proportion of patients with final post-PCI IMR &gt;25</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the change from baseline in the IMR following PCI</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <other_outcome>
    <measure>'As Treated' analysis of the proportion of patients with final post-PCI IMRc &gt;25</measure>
    <time_frame>1 day</time_frame>
    <description>The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).&#xD;
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Coronary Stenosis</condition>
  <arm_group>
    <arm_group_label>PIOS Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Operator-blinded pre and post-PCI coronary physiology measurements will be recorded. If FFR is &lt;0.90, the result will be disclosed to the operator and a hyperaemic pressure wire pullback will be performed during a standard peripheral intravenous adenosine infusion (140mcg/kg/min).&#xD;
The operator will then follow the PIOS protocol to attempt to obtain the target optimal post-PCI FFR result.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Operator-blinded pre and post-PCI coronary physiology measurements will be recorded and the angiographically defined result will be accepted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>P.I.O.S.</intervention_name>
    <description>Physiologically-Guided Incremental Optimisation Strategy</description>
    <arm_group_label>PIOS Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pre and post-PCI coronary physiology measurements</intervention_name>
    <description>Pre and post-PCI coronary physiology measurements will be performed but not disclosed to the operator</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>PIOS Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt;18 years of age with coronary artery disease (including stable angina and&#xD;
             stabilised non-ST-elevation myocardial infarction (NSTEMI)) who are able to provide&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PCI in a coronary artery bypass graft&#xD;
&#xD;
          -  PCI to an in-stent restenosis (ISR) lesion&#xD;
&#xD;
          -  PCI to a target artery providing Rentrop grade 2 or 3 collateral blood supply to&#xD;
             another vessel&#xD;
&#xD;
          -  Inability to receive adenosine (for example, severe reactive airway disease, marked&#xD;
             hypotension, or advanced atrioventricular block without pacemaker).&#xD;
&#xD;
          -  Recent (within 1 week prior to cardiac catheterization) ST-segment elevation&#xD;
             myocardial infarction (STEMI) in any arterial distribution (not specifically target&#xD;
             lesion).&#xD;
&#xD;
          -  Severe cardiomyopathy (ejection fraction &lt;30%).&#xD;
&#xD;
          -  Renal insufficiency such that an additional 20 to 30 mL of contrast would, in the&#xD;
             opinion of the operator, pose unwarranted risk to the patient.&#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>Keith G Oldroyd, MB, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NHS National Waiting Times Centre Board (NHS Golden Jubilee)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Golden Jubilee National Hospital</name>
      <address>
        <city>Glasgow</city>
        <zip>G81 4DY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Collison D, McClure JD, Berry C, Oldroyd KG. A randomized controlled trial of a physiology-guided percutaneous coronary intervention optimization strategy: Rationale and design of the TARGET FFR study. Clin Cardiol. 2020 May;43(5):414-422. doi: 10.1002/clc.23342. Epub 2020 Feb 10.</citation>
    <PMID>32037592</PMID>
  </reference>
  <results_reference>
    <citation>Collison D, Didagelos M, Aetesam-Ur-Rahman M, Copt S, McDade R, McCartney P, Ford TJ, McClure J, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR). Eur Heart J. 2021 Dec 1;42(45):4656-4668. doi: 10.1093/eurheartj/ehab449.</citation>
    <PMID>34279606</PMID>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>March 16, 2022</last_update_submitted>
  <last_update_submitted_qc>March 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>NHS National Waiting Times Centre Board</investigator_affiliation>
    <investigator_full_name>Prof. Keith G. Oldroyd</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>FFR Targeted PCI</keyword>
  <keyword>Post-PCI FFR</keyword>
  <keyword>Physiology-guided PCI Optimisation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Coronary Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03259815/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03259815/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03259815
org study id: 17/CARD/10
secondary id: IRAS ID 223780
nct id: NCT03259815
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There has recently been renewed interest in the measurement of post percutaneous coronary
      intervention (PCI) Fractional Flow Reserve (FFR). Previous studies have suggested that
      post-PCI FFR values ≥0.90 are associated with better clinical outcomes for patients but the
      available data suggest that despite angiographically satisfactory results, this is actually
      achieved in less than 40% of cases.

      The main mechanisms for sub-optimal post-PCI FFR measurements have been proposed to be
      suboptimal stent deployment, unmasking of a second lesion in the target vessel post PCI,
      residual diffuse disease in the untreated segments and pressure drift (a technical artefact
      of pressure wire technology).

      Using post-PCI FFR to guide stent optimisation and/or further intervention in the target
      vessel has been shown to increase the frequency of achieving optimal post-PCI FFR results
      (and therefore presumably better clinical outcomes). However, there are additional costs
      involved in the routine use of post-PCI FFR and it is not clear just how often it is even
      possible to increase the initial post-PCI FFR to ≥0.90. This uncertainty means that it is
      currently difficult to either recommend the routine use of post-PCI FFR or justify its cost.

      The investigators propose a prospective study to assess the feasibility of achieving post-PCI
      FFR ≥0.90 during standard PCI procedures in consecutive patients. The study would also
      attempt to elucidate the mechanisms for sub-optimal FFR results when they occur. The
      investigators anticipate using the data from this developmental study to support a subsequent
      funding application for a definitive phase 3 study of the impact of FFR targeted PCI on
      clinical outcomes.
Original hypothesis

      A simple Physiology-guided Incremental Optimisation Strategy (PIOS) can increase the
      proportion of patients undergoing PCI in whom a post-PCI FFR ≥0.90 can be achieved from 40%
      to 60%.

      Experimental details and design of proposed investigation

      Overall aim:

      A randomised controlled trial of a physiology-guided optimisation strategy to determine the
      feasibility of increasing the proportion of post-PCI FFR measurements ≥0.90 in a consecutive
      series of patients undergoing standard PCI procedures.

      Study Population:

      260 consecutive patients with stable angina referred for invasive management to the cardiac
      catheterisation lab who have been selected to undergo PCI based on either angiographic
      appearances or prior FFR assessment. Patients will be caffeine free for >12 hours
      pre-procedure.

      Methods/Design:

      Informed consent will be obtained prior to cardiac catheterisation in all potential subjects
      conforming to the inclusion and exclusion criteria.

      Patients will then be randomised to one of two groups (described below) and PCI will be
      performed, using a pressure guidewire, according to standard practice at the Golden Jubilee
      National Hospital (including lesion pre-dilation and post-dilation of the stented segment).

      Group 1 (PIOS Group):

      Operator-blinded coronary physiology measurements will be recorded pre and post PCI.

      If the post-PCI FFR is ≥0.90, no further intervention will be performed and the procedure is
      considered complete.

      If post-PCI FFR is <0.90, the result will be disclosed to the operator and a hyperaemic
      pressure wire pullback during a standard peripheral intravenous adenosine infusion
      (140mcg/kg/min) will be performed. Depending on the result the operator would then have the
      following options:

      A. If there is a step-up of ≥0.05 across the stented segment(s) further post-dilatation with
      a 0.25 - 0.50mm larger non-compliant balloon to at least 18 atmospheres should be performed
      followed by repeat FFR. Alternatively, the operator may choose to employ intracoronary
      imaging (IVUS or OCT) to guide post-dilation/optimisation of the stented segment.

      B. If there is a step-up of ≥0.05 across a relatively focal (<20mm) unstented segment which
      is technically suitable for further stenting then a further stent should be implanted
      followed by repeat FFR.

      C. If the FFR remains <0.90 after steps A +/- B, a further FFR pullback will be performed. If
      the criteria for Step B are again met, one additional stent may be deployed and a final FFR
      pullback performed. Following this, the FFR result will be accepted.

      D. If the residual pressure gradient is interpreted to reflect diffuse atherosclerosis with
      no focal step-ups, the result is accepted.

      E. At the end of the procedure the pressure wire sensor will be withdrawn to the tip of the
      guiding catheter and compared with the aortic pressure. A pressure drift of ≤0.03 will be
      accepted and the final FFR result adjusted accordingly.

      F. If there is a drift of ≥0.04, the wire should be re-equalised and the final FFR
      measurement be repeated.

      G. The patients will have their demographics and procedure details recorded. All patients
      will be asked to complete follow-up questionnaires at 3 months.

      Group 2 (Control Group):

      Pre and post-PCI coronary physiology measurements will be recorded but not disclosed to the
      operator. The angiographically defined result will be accepted. The patients will have their
      demographics and procedure details recorded. All patients will be asked to complete follow-up
      questionnaires at 3 months.

      Expected value of results

        1. Confirmation that the proposed PIOS protocol significantly increases the proportion of
           patients obtaining a physiologically optimal post-PCI result will demonstrate the
           feasibility of this strategy and should lead to an increase in post-PCI pressure wire
           usage to achieve physiologically optimal results for patients.

           The investigators hypothesise that the PIOS intervention can increase the proportion of
           patients achieving this target from 40% to 60% and believe that an increment of at least
           this magnitude would be necessary to make a future larger study with both
           patient-oriented clinical (target vessel failure) and health care system (resource
           utilisation) outcomes acceptable to the interventional cardiology community and
           potential funders.

        2. The secondary outcome measures, albeit underpowered for clinical outcomes in this study,
           will hopefully still give a signal that achieving a target post-PCI FFR ≥0.90 does yield
           objective benefits for patients. This could then form the basis for a larger phase 3
           trial to confirm improved clinical outcomes and cost- effectiveness of FFR-targeted PCI
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised Controlled Trial
primary purpose: Treatment
masking: Single (Care Provider)
masking description: Operator blinded pre and post PCI coronary physiology measurements will be performed in both arms of the study.
Post-PCI FFR results <0.90 in the interventional arm will be disclosed to the operator to allow further intervention
measure: The proportion of patients with a final post-PCI FFR result ≥0.90
time frame: 1 day
description: The proportion of patients with a final post-PCI FFR result ≥0.90 will be compared between the randomised groups
measure: The proportion of patients with final post-PCI FFR ≤0.80
time frame: 1 day
description: The proportion of patients with a final post-PCI FFR result ≤0.80 will be compared between the randomised groups
measure: Change from baseline in self-reported health outcomes at 3 months using a disease-specific quality of life measurement tool.
time frame: 3 months
description: Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline pre-procedure and again at 3 months post PCI
measure: Change from baseline in self-reported health outcomes at 3 months using a generic quality of life measurement tool.
time frame: 3 months
description: Patients will complete the EQ-5D questionnaire at baseline pre-procedure and again at 3 months post PCI
measure: The rate of target vessel failure (TVF) and its component features at 3 months.
time frame: 3 months
description: Component features of TVF include cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalisation with target vessel revascularisation.
measure: The rate of target vessel failure (TVF) and its component features at 1 year.
time frame: 1 year
description: Component features of TVF include cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalisation with target vessel revascularisation.
measure: Change from baseline in the FFR following PCI
time frame: 1 day
description: The difference between measurements of Fractional Flow Reserve taken in the target vessel pre- and post-PCI
measure: The proportion of patients with final post-PCI dPR ≥0.90
time frame: 1 day
description: The proportion of patients with a final post-PCI Diastolic Pressure Ratio (dPR) value ≥0.90
measure: Change from baseline in the Diastolic Pressure Ratio (dPR) following PCI
time frame: 1 day
description: The difference between measurements of the Diastolic Pressure Ratio taken in the target vessel pre and post PCI
measure: The proportion of patients with final post-PCI RFR ≥0.90
time frame: 1 day
description: The proportion of patients with a final post-PCI Resting Full-cycle Ratio (RFR) value ≥0.90
measure: Change from baseline in the Resting Full-Cycle Ratio (RFR) following PCI
time frame: 1 day
description: The difference between measurements of the Resting Full-Cycle Ratio (the lowest Pd/Pa ratio during the whole cardiac cycle at rest) taken in the target vessel pre and post PCI
measure: Change in TTrest following PCI
time frame: 1 day
description: Change of the thermodilution-derived resting transit time (TTrest) from pre-PCI to final post-PCI value
measure: Change in TThyp following PCI
time frame: 1 day
description: Change of the thermodilution-derived hyperaemic transit time (TThyp) from pre-PCI to final post-PCI value
measure: The proportion of patients with final post-PCI CFR value ≥2.0
time frame: 1 day
description: The proportion of patients with a final post-PCI Coronary Flow Reserve (CFR) result ≥2.0
measure: Change from baseline in the Coronary Flow Reserve (CFR) following PCI
time frame: 1 day
description: The difference between measurements of Coronary Flow Reserve taken in the target vessel pre and post PCI
measure: The proportion of patients with final post-PCI IMR >25
time frame: 1 day
description: The proportion of patients with a final post-PCI Index of Microcirculatory Resistance (IMR) value >25
measure: Change from baseline in the Index of Microcirculatory Resistance (IMR) following PCI
time frame: 1 day
description: The difference between measurements of IMR taken in the target vessel pre and post PCI
measure: The proportion of patients with final post-PCI IMRc >25
time frame: 1 day
description: The proportion of patients with a final post-PCI corrected Index of Microcirculatory Resistance (IMRc) value >25
measure: Procedure Duration
time frame: 1 day
description: The time required to perform the PIOS intervention procedures will be compared with those in the control group.
measure: The cost of additional equipment employed in the experimental arm
time frame: 1 day
description: The cost of additional equipment employed in the PIOS intervention (i.e. balloons/stents/intra-coronary imaging).
measure: Fluoroscopy Dose
time frame: 1 day
description: The radiation doses for the PIOS intervention procedures will be compared with those in the control group.
measure: Contrast Material Dose
time frame: 1 day
description: The contrast material doses for the PIOS intervention procedures will be compared with those in the control group.
measure: Incidence of procedural complications such as coronary artery dissection or perforation.
time frame: 1 day
description: The incidence of procedural complications such as coronary artery dissection or perforation will be recorded and compared between the two study arms
measure: 'As Treated' analysis of the proportion of patients with a final post-PCI FFR result ≥0.90
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the proportion of patients with final post-PCI FFR ≤0.80
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the change from baseline in self-reported health outcomes at 3 months as assessed by the Seattle Angina Questionnaire (SAQ)
time frame: 3 months
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the change from baseline in self-reported health outcomes at 3 months as assessed by the EQ-5D questionnaire.
time frame: 3 months
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the rate of target vessel failure (TVF) and its component features at 3 months.
time frame: 3 months
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the rate of target vessel failure (TVF) and its component features at 1 year.
time frame: 1 year
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the change from baseline in the FFR following PCI
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the proportion of patients with final post-PCI dPR ≥0.90
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the change from baseline in the dPR following PCI
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the proportion of patients with final post-PCI RFR ≥0.90
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the change from baseline in the RFR following PCI
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the change in TTrest following PCI
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the change in TThyp following PCI
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the proportion of patients with final post-PCI CFR value ≥2.0
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the change from baseline in the CFR following PCI
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the proportion of patients with final post-PCI IMR >25
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the change from baseline in the IMR following PCI
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
measure: 'As Treated' analysis of the proportion of patients with final post-PCI IMRc >25
time frame: 1 day
description: The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).
An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.
arm group label: PIOS Intervention Group
arm group type: Experimental
description: Operator-blinded pre and post-PCI coronary physiology measurements will be recorded. If FFR is <0.90, the result will be disclosed to the operator and a hyperaemic pressure wire pullback will be performed during a standard peripheral intravenous adenosine infusion (140mcg/kg/min).
The operator will then follow the PIOS protocol to attempt to obtain the target optimal post-PCI FFR result.
arm group label: Control Group
arm group type: Active Comparator
description: Operator-blinded pre and post-PCI coronary physiology measurements will be recorded and the angiographically defined result will be accepted.
intervention type: Procedure
intervention name: P.I.O.S.
description: Physiologically-Guided Incremental Optimisation Strategy
arm group label: PIOS Intervention Group
intervention type: Diagnostic Test
intervention name: Pre and post-PCI coronary physiology measurements
description: Pre and post-PCI coronary physiology measurements will be performed but not disclosed to the operator
arm group label: Control Group
arm group label: PIOS Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Keith G Oldroyd, MB, MD
role: Principal Investigator
affiliation: NHS National Waiting Times Centre Board (NHS Golden Jubilee)
facility: 
country: United Kingdom
citation: Collison D, McClure JD, Berry C, Oldroyd KG. A randomized controlled trial of a physiology-guided percutaneous coronary intervention optimization strategy: Rationale and design of the TARGET FFR study. Clin Cardiol. 2020 May;43(5):414-422. doi: 10.1002/clc.23342. Epub 2020 Feb 10.
PMID: 32037592
citation: Collison D, Didagelos M, Aetesam-Ur-Rahman M, Copt S, McDade R, McCartney P, Ford TJ, McClure J, Lindsay M, Shaukat A, Rocchiccioli P, Brogan R, Watkins S, McEntegart M, Good R, Robertson K, O'Boyle P, Davie A, Khan A, Hood S, Eteiba H, Berry C, Oldroyd KG. Post-stenting fractional flow reserve vs coronary angiography for optimization of percutaneous coronary intervention (TARGET-FFR). Eur Heart J. 2021 Dec 1;42(45):4656-4668. doi: 10.1093/eurheartj/ehab449.
PMID: 34279606
responsible party type: Principal Investigator
investigator affiliation: NHS National Waiting Times Centre Board
investigator full name: Prof. Keith G. Oldroyd
investigator title: Principal Investigator
mesh term: Coronary Artery Disease
mesh term: Coronary Stenosis
sharing ipd: No
provided document: 
provided document: 