<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/NCT03000270</url>
  </required_header>
  <id_info>
    <org_study_id>DTU - Safety and Feasibility</org_study_id>
    <nct_id>NCT03000270</nct_id>
  </id_info>
  <brief_title>Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study</brief_title>
  <acronym>DTU</acronym>
  <official_title>Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abiomed Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abiomed Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in&#xD;
      patients with ST-elevation myocardial infarction (STEMI) is safe and feasible&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multi-center, prospective, randomized, two-arm feasibility trial to assess the potential&#xD;
      role of unloading with the Impella CP prior to revascularization in reducing infarct size.&#xD;
      The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading&#xD;
      with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate&#xD;
      Arm: initiation of Impella CP unloading followed immediately by PPCI.&#xD;
&#xD;
      Study Hypothesis: Direct active unloading of the left ventricle with the Impella CP System&#xD;
      prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and&#xD;
      feasible&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 11, 2017</start_date>
  <completion_date type="Actual">August 16, 2018</completion_date>
  <primary_completion_date type="Actual">June 19, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infarct size at 30 Days</measure>
    <time_frame>30 Days</time_frame>
    <description>Assessment of infarct size as percent of left ventricular (LV) mass, evaluated using CMR, at 30 days post-PPCI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MACCE at 30 Days</measure>
    <time_frame>30 Days</time_frame>
    <description>A composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days:&#xD;
Cardiovascular mortality&#xD;
Re-infarction&#xD;
Stroke/TIA&#xD;
Major vascular complication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infarct Characteristics - LV mass</measure>
    <time_frame>3 - 5 and 30 Days</time_frame>
    <description>Using CMR at 3-5 &amp; 30 days, assessement of Infarct size as a percent of LV mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infarct Characteristics - area at risk</measure>
    <time_frame>3 - 5 and 30 Days</time_frame>
    <description>Using CMR at 3-5 &amp; 30 days, assessment of Infarct size as a percent of area (myocardium) at risk,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 Day Safety Endpoint Rates</measure>
    <time_frame>30 Days</time_frame>
    <description>Event rate for All-cause mortality, Cardiovascular mortality, Re-infarction, Stroke/TIA, Vascular complications, Worsening heart failure or hemodynamic compromise requiring inotropic or hemodynamic support post Impella explant, Repeat revascularization, Aortic valve injury or dysfunction, Renal failure, Hemolysis, Hematoma, Bleeding, Thrombocytopenia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infarct Characteristics microvascular obstruction</measure>
    <time_frame>3-5 and 30 Days</time_frame>
    <description>Using CMR at 3-5 &amp; 30 days, measurement of percent of microvascular obstruction (%MVO)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Function- LV end systolic and diastolic volume index</measure>
    <time_frame>3-5 and 30 Days</time_frame>
    <description>Using CMR imaging post PCI: assessment of LV end systolic and diastolic volume index (LVESVi &amp; LVEDVi)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Function - Ejection Fraction</measure>
    <time_frame>3-5 and 30 Days</time_frame>
    <description>Using CMR at 3-5 &amp; 30 days post PCI: assessment of Ejection fraction (EF)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>STEMI</condition>
  <arm_group>
    <arm_group_label>Prolonged unloading prior to PPCI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Activation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immediate unloading prior to PPCI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Activation of Impella CP immediately prior to primary percutaneous coronary intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Impella unloading prior to PPCI</intervention_name>
    <description>Impella unloading prior to PPCI</description>
    <arm_group_label>Immediate unloading prior to PPCI</arm_group_label>
    <arm_group_label>Prolonged unloading prior to PPCI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Age 21-80 years&#xD;
&#xD;
          -  First myocardial infarction&#xD;
&#xD;
          -  Acute anterior STEMI with ≥ 2 mm in 2 or more contiguous anterior leads or≥ 4 mm total&#xD;
             ST-segment deviation sum in the anterior leads&#xD;
&#xD;
          -  Signed Informed Consent&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  Cardiogenic shock defined as: systemic hypotension (systolic BP less than 90 mmHg or&#xD;
             the need for inotropes/pressors to maintain a systolic BP Greater than 90mmHg) plus&#xD;
             one of the following: any requirement for pressors/inotropes prior to arrival at the&#xD;
             cath lab, clinical evidence of end organ hypoperfusion, lactate level greater than&#xD;
             2.5mmol/L&#xD;
&#xD;
          -  Inferior STEMI or suspected right ventricular failure&#xD;
&#xD;
          -  Suspected or known pregnancy&#xD;
&#xD;
          -  Suspected active infection&#xD;
&#xD;
          -  History or known hepatic insufficiency prior to catheterization&#xD;
&#xD;
          -  On dialysis therapy&#xD;
&#xD;
          -  Known contraindication to:&#xD;
&#xD;
          -  Undergoing MRI or use of gadolinium&#xD;
&#xD;
          -  Heparin, pork, pork products or contrast media&#xD;
&#xD;
          -  Receiving a drug-eluting stent&#xD;
&#xD;
          -  Participation in the active treatment or follow-up phase of another clinical study of&#xD;
             an investigational drug or device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Banner Good Samaritan Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellstar/Kennestone Hospital</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Detroit Medical Center</name>
      <address>
        <city>Detroit</city>
        <state>Illinois</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Edward Hospital</name>
      <address>
        <city>Oakbrook Terrace</city>
        <state>Illinois</state>
        <zip>60089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ABIOMED, Inc.</name>
      <address>
        <city>Danvers</city>
        <state>Massachusetts</state>
        <zip>01923</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Buffalo Hospital</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Einstein Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Health System</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Hospital</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Kapur NK, Alkhouli MA, DeMartini TJ, Faraz H, George ZH, Goodwin MJ, Hernandez-Montfort JA, Iyer VS, Josephy N, Kalra S, Kaki A, Karas RH, Kimmelstiel CD, Koenig GC, Lau E, Lotun K, Madder RD, Mannino SF, Meraj PM, Moreland JA, Moses JW, Kim RL, Schreiber TL, Udelson JE, Witzke C, Wohns DHW, O'Neill WW. Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction. Circulation. 2019 Jan 15;139(3):337-346. doi: 10.1161/CIRCULATIONAHA.118.038269.</citation>
    <PMID>30586728</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>May 2, 2019</last_update_submitted>
  <last_update_submitted_qc>May 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infarct Size</keyword>
  <keyword>Impella</keyword>
  <keyword>Unloading</keyword>
  <keyword>Left Ventricle</keyword>
  <keyword>PPCI</keyword>
  <keyword>STEMI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03000270
org study id: DTU - Safety and Feasibility
nct id: NCT03000270
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in
      patients with ST-elevation myocardial infarction (STEMI) is safe and feasible
A multi-center, prospective, randomized, two-arm feasibility trial to assess the potential
      role of unloading with the Impella CP prior to revascularization in reducing infarct size.
      The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading
      with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate
      Arm: initiation of Impella CP unloading followed immediately by PPCI.

      Study Hypothesis: Direct active unloading of the left ventricle with the Impella CP System
      prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and
      feasible
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Infarct size at 30 Days
time frame: 30 Days
description: Assessment of infarct size as percent of left ventricular (LV) mass, evaluated using CMR, at 30 days post-PPCI
measure: MACCE at 30 Days
time frame: 30 Days
description: A composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days:
Cardiovascular mortality
Re-infarction
Stroke/TIA
Major vascular complication
measure: Infarct Characteristics - LV mass
time frame: 3 - 5 and 30 Days
description: Using CMR at 3-5 & 30 days, assessement of Infarct size as a percent of LV mass
measure: Infarct Characteristics - area at risk
time frame: 3 - 5 and 30 Days
description: Using CMR at 3-5 & 30 days, assessment of Infarct size as a percent of area (myocardium) at risk,
measure: 30 Day Safety Endpoint Rates
time frame: 30 Days
description: Event rate for All-cause mortality, Cardiovascular mortality, Re-infarction, Stroke/TIA, Vascular complications, Worsening heart failure or hemodynamic compromise requiring inotropic or hemodynamic support post Impella explant, Repeat revascularization, Aortic valve injury or dysfunction, Renal failure, Hemolysis, Hematoma, Bleeding, Thrombocytopenia
measure: Infarct Characteristics microvascular obstruction
time frame: 3-5 and 30 Days
description: Using CMR at 3-5 & 30 days, measurement of percent of microvascular obstruction (%MVO)
measure: Left Ventricular Function- LV end systolic and diastolic volume index
time frame: 3-5 and 30 Days
description: Using CMR imaging post PCI: assessment of LV end systolic and diastolic volume index (LVESVi & LVEDVi)
measure: Left Ventricular Function - Ejection Fraction
time frame: 3-5 and 30 Days
description: Using CMR at 3-5 & 30 days post PCI: assessment of Ejection fraction (EF)
arm group label: Prolonged unloading prior to PPCI
arm group type: Active Comparator
description: Activation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention
arm group label: Immediate unloading prior to PPCI
arm group type: Active Comparator
description: Activation of Impella CP immediately prior to primary percutaneous coronary intervention
intervention type: Device
intervention name: Impella unloading prior to PPCI
description: Impella unloading prior to PPCI
arm group label: Immediate unloading prior to PPCI
arm group label: Prolonged unloading prior to PPCI
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
country: United States
citation: Kapur NK, Alkhouli MA, DeMartini TJ, Faraz H, George ZH, Goodwin MJ, Hernandez-Montfort JA, Iyer VS, Josephy N, Kalra S, Kaki A, Karas RH, Kimmelstiel CD, Koenig GC, Lau E, Lotun K, Madder RD, Mannino SF, Meraj PM, Moreland JA, Moses JW, Kim RL, Schreiber TL, Udelson JE, Witzke C, Wohns DHW, O'Neill WW. Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction. Circulation. 2019 Jan 15;139(3):337-346. doi: 10.1161/CIRCULATIONAHA.118.038269.
PMID: 30586728
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No