<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/NCT02197325</url>
  </required_header>
  <id_info>
    <org_study_id>CIP2014-03</org_study_id>
    <nct_id>NCT02197325</nct_id>
  </id_info>
  <brief_title>PiCSO in ACS Study</brief_title>
  <official_title>Pressure Controlled Intermittent Coronary Sinus Occlusion (PiCSO) as an Adjunct to PCI in Acute Coronary Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miracor Medical SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Miracor Medical SA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to find out whether PICSO (Pressure Controlled Coronary&#xD;
      Sinus Occlusion), given concomitant to (NSTEMI) or following (STEMI) primary PCI and&#xD;
      stenting, can improve final infarct size and myocardial function.&#xD;
&#xD;
      ACS patients, NSTEMI and STEMI, with a culprit lesion in the LAD will be treated according to&#xD;
      standard treatment, PCI followed by stent placement, with or without PICSO therapy. In NSTEMI&#xD;
      patients, PICSO therapy will be given during PCI and stenting for a minimum of 30 minutes or&#xD;
      the duration of the PCI and stent procedure. In STEMI patients PICSO therapy will be given&#xD;
      after successful primary percutaneous coronary intervention of a left anterior descending&#xD;
      coronary artery culprit lesion. PICSO therapy is initiated prior to stent deployment and&#xD;
      continued during stenting. The functional efficacy measures, related to the PICSO duration&#xD;
      and coronary sinus pressures, will be stored on the PICSO Impulse console and analysed&#xD;
      offline. The clinical efficacy measures, cardiac enzyme release during 24 hour following PCI,&#xD;
      cardiac function, infarct size and level of microvascular obstruction will be assessed by&#xD;
      cMRI. Patients will be followed for a maximum of 4 months after the primary PCI procedure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed to evaluate the effect of PICSO treatment concomitant to or following&#xD;
      primary PCI in patients with anterior non ST-segment Elevation Myocardial Infarction or&#xD;
      ST-segment Elevation Myocardial Infarction, in patients with a culprit lesion in the LAD on&#xD;
      Infarct Size and myocardial function. There will be 2 phases in this study.&#xD;
&#xD;
        1. Phase 1: only NSTEMI patients will be recruited.&#xD;
&#xD;
        2. Phase 2: only STEMI patients will be recruited.&#xD;
&#xD;
      Phase 1 During Phase 1 of the study only NSTEMI patients will be recruited. After having&#xD;
      given informed consent the patient will be scheduled for pPCI and stent placement. On the day&#xD;
      of the procedure the PICSO catheter will be placed as described below (refer to PICSO Impulse&#xD;
      catheter placement). After the PICSO therapy is started the standard pPCI and stent placement&#xD;
      is performed. PICSO is continued at a minimum of 30 minutes or as long as the standard pPCI&#xD;
      and stent placement takes.&#xD;
&#xD;
      Phase 2 During Phase 2 of the study only STEMI patients will be recruited. Immediately after&#xD;
      successful restoration of the blood flow the PICSO Impulse catheter is introduced and placed&#xD;
      as described below (Refer to PICSO Impulse catheter placement).&#xD;
&#xD;
      After correct positioning of the PICSO Impulse catheter, the 0,032&quot; guide wire is removed.&#xD;
      PICSO therapy is initiated and continued until a PICSO Quantity of 1000 mmHg is reached or a&#xD;
      maximum of 60 minutes active treatment whatever comes first. With PICSO in treatment mode,&#xD;
      the stent is deployed.&#xD;
&#xD;
      The clinical outcome data collected will be based on the site standards of care for NSTEMI&#xD;
      and acute STEMI. Examinations include but are not limited to physical assessments, cardiac&#xD;
      markers, ECG, laboratory results, x-rays, angiograms, cMRI and echocardiography.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Infarct Size assessed by cardiac MRI</measure>
    <time_frame>baseline and 4 months</time_frame>
    <description>Efficacy of PICSO treatment as assessed by means of infarct size reduction assessment, 4-months vs. 1 week post-primary PCI in comparison with a matched non-PICSO parallel control group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Enzymatic Infarct Size</measure>
    <time_frame>12 hours post PCI</time_frame>
    <description>Peak Troponin level 12 hours after pPCI, in comparison with a matched non-PICSO parallel control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Microvascular Obstruction assessed by cardia MRI</measure>
    <time_frame>2-5 days post PCI</time_frame>
    <description>Microvascular Obstruction assessed by cardiac MRI on 2-5 days post pPCI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Infarct size assessment by cardiac MRI</measure>
    <time_frame>baseline and 4 months</time_frame>
    <description>Infarct size assessment by cardiac MRI (presented as % of Area at Risk, AAR, and % of LV) at 2-5 days and 120 ± 14 days post-primary PCI in comparison with a matched non-PICSO parallel control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACE</measure>
    <time_frame>baseline to 4 months</time_frame>
    <description>Occurrence of major adverse cardiac events (MACE) during follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>PICSO</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants enrolled in the PICSO treatment Group will be treated with PICSO concomitant to pPCI in patients with anterior non ST-segment Elevation Myocardial Infarction or following pPCI in ST-segment Elevation Myocardial Infarction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parallel control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants enrolled in will receive treatment based on the standard guidelines for treatment of a myocardial infarction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PICSO</intervention_name>
    <description>Pressure controlled Intermittent Coronary Pressure Occlusion</description>
    <arm_group_label>PICSO</arm_group_label>
    <other_name>PICSO Impulse System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with first time symptoms of acute coronary syndrome (NSTEMI and STEMI)&#xD;
&#xD;
          2. Culprit lesion in the LAD.&#xD;
&#xD;
          3. Age range 25 - 75 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Complicated PCI of an LAD culprit lesion (defined as angioplasty followed by stent&#xD;
             placement or direct stenting with the occurrence of an adverse event(s) that would&#xD;
             preclude further interventional procedures during the index procedure, such as major&#xD;
             bleeding, perforation, hypotension, pulmonary edema or instability that in the&#xD;
             judgment of the investigator precludes use of the PICSO Impulse System).&#xD;
&#xD;
          2. Previous coronary artery bypass graft surgery&#xD;
&#xD;
          3. History of stroke, TIA or reversible ischemic neurological disease within last 6&#xD;
             months&#xD;
&#xD;
          4. Hospitalization with a primary diagnosis of acute myocardial infarction (AMI)&#xD;
             previously or has evidence of previous Q-wave infarct&#xD;
&#xD;
          5. Known contra-indication for magnetic resonance imaging (Metallic implant precluding&#xD;
             MRI, claustrophobia, obesity precluding MRI, etc.)&#xD;
&#xD;
          6. Active or treated malignancies in the last 12 months&#xD;
&#xD;
          7. Pregnant Women&#xD;
&#xD;
          8. Non-cardiac comorbidities and life expectancy &lt; 1 year&#xD;
&#xD;
          9. Use of warfarin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Azfar Zaman, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Freeman Hospital Newcastle</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Liverpool Heart and Chest Hospital</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Bartholomew's Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Freeman Hospital</name>
      <address>
        <city>Newcastle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern General Hospital</name>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>March 14, 2019</last_update_submitted>
  <last_update_submitted_qc>March 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NSTEMI and STEMI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02197325
org study id: CIP2014-03
nct id: NCT02197325
lead sponsor: 
has dmc: No
The purpose of this research study is to find out whether PICSO (Pressure Controlled Coronary
      Sinus Occlusion), given concomitant to (NSTEMI) or following (STEMI) primary PCI and
      stenting, can improve final infarct size and myocardial function.

      ACS patients, NSTEMI and STEMI, with a culprit lesion in the LAD will be treated according to
      standard treatment, PCI followed by stent placement, with or without PICSO therapy. In NSTEMI
      patients, PICSO therapy will be given during PCI and stenting for a minimum of 30 minutes or
      the duration of the PCI and stent procedure. In STEMI patients PICSO therapy will be given
      after successful primary percutaneous coronary intervention of a left anterior descending
      coronary artery culprit lesion. PICSO therapy is initiated prior to stent deployment and
      continued during stenting. The functional efficacy measures, related to the PICSO duration
      and coronary sinus pressures, will be stored on the PICSO Impulse console and analysed
      offline. The clinical efficacy measures, cardiac enzyme release during 24 hour following PCI,
      cardiac function, infarct size and level of microvascular obstruction will be assessed by
      cMRI. Patients will be followed for a maximum of 4 months after the primary PCI procedure
The study is designed to evaluate the effect of PICSO treatment concomitant to or following
      primary PCI in patients with anterior non ST-segment Elevation Myocardial Infarction or
      ST-segment Elevation Myocardial Infarction, in patients with a culprit lesion in the LAD on
      Infarct Size and myocardial function. There will be 2 phases in this study.

        1. Phase 1: only NSTEMI patients will be recruited.

        2. Phase 2: only STEMI patients will be recruited.

      Phase 1 During Phase 1 of the study only NSTEMI patients will be recruited. After having
      given informed consent the patient will be scheduled for pPCI and stent placement. On the day
      of the procedure the PICSO catheter will be placed as described below (refer to PICSO Impulse
      catheter placement). After the PICSO therapy is started the standard pPCI and stent placement
      is performed. PICSO is continued at a minimum of 30 minutes or as long as the standard pPCI
      and stent placement takes.

      Phase 2 During Phase 2 of the study only STEMI patients will be recruited. Immediately after
      successful restoration of the blood flow the PICSO Impulse catheter is introduced and placed
      as described below (Refer to PICSO Impulse catheter placement).

      After correct positioning of the PICSO Impulse catheter, the 0,032" guide wire is removed.
      PICSO therapy is initiated and continued until a PICSO Quantity of 1000 mmHg is reached or a
      maximum of 60 minutes active treatment whatever comes first. With PICSO in treatment mode,
      the stent is deployed.

      The clinical outcome data collected will be based on the site standards of care for NSTEMI
      and acute STEMI. Examinations include but are not limited to physical assessments, cardiac
      markers, ECG, laboratory results, x-rays, angiograms, cMRI and echocardiography.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Infarct Size assessed by cardiac MRI
time frame: baseline and 4 months
description: Efficacy of PICSO treatment as assessed by means of infarct size reduction assessment, 4-months vs. 1 week post-primary PCI in comparison with a matched non-PICSO parallel control group
measure: Enzymatic Infarct Size
time frame: 12 hours post PCI
description: Peak Troponin level 12 hours after pPCI, in comparison with a matched non-PICSO parallel control group
measure: Level of Microvascular Obstruction assessed by cardia MRI
time frame: 2-5 days post PCI
description: Microvascular Obstruction assessed by cardiac MRI on 2-5 days post pPCI
measure: Absolute Infarct size assessment by cardiac MRI
time frame: baseline and 4 months
description: Infarct size assessment by cardiac MRI (presented as % of Area at Risk, AAR, and % of LV) at 2-5 days and 120 ± 14 days post-primary PCI in comparison with a matched non-PICSO parallel control group.
measure: MACE
time frame: baseline to 4 months
description: Occurrence of major adverse cardiac events (MACE) during follow-up
arm group label: PICSO
arm group type: Active Comparator
description: Participants enrolled in the PICSO treatment Group will be treated with PICSO concomitant to pPCI in patients with anterior non ST-segment Elevation Myocardial Infarction or following pPCI in ST-segment Elevation Myocardial Infarction
arm group label: Parallel control
arm group type: No Intervention
description: Participants enrolled in will receive treatment based on the standard guidelines for treatment of a myocardial infarction.
intervention type: Device
intervention name: PICSO
description: Pressure controlled Intermittent Coronary Pressure Occlusion
arm group label: PICSO
other name: PICSO Impulse System
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: No
last name: Azfar Zaman, Prof. Dr.
role: Principal Investigator
affiliation: Freeman Hospital Newcastle
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome