<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/NCT03809494</url>
  </required_header>
  <id_info>
    <org_study_id>15-03</org_study_id>
    <nct_id>NCT03809494</nct_id>
  </id_info>
  <brief_title>HemaTrate™ in the Treatment of Critical Limb Ischemia</brief_title>
  <official_title>Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cook Research Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cook Group Incorporated</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood&#xD;
      Filtration system in the treatment of critical limb ischemia. The primary endpoint measure is&#xD;
      comparing the percentage of patients between the treatment arm and control arm who have&#xD;
      freedom from major amputation, arterial intervention below the knee, and death through 12&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study has stopped early due to enrollment challenges related largely to the current&#xD;
    pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">July 23, 2019</start_date>
  <completion_date type="Actual">November 27, 2020</completion_date>
  <primary_completion_date type="Actual">November 27, 2020</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>The investigator for this study is the person that will be performing the injections throughout the study and will know the participant's treatment (TNC or saline). The investigator that is aware of the participant's treatment will not be performing the follow-up visits.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from vascular or endovascular arterial intervention below the knee of the study leg</measure>
    <time_frame>12 months</time_frame>
    <description>Percent of patients that have vascular or endovascular arterial intervention reported below the knee of the study leg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Freedom from major amputation of the study leg</measure>
    <time_frame>12 months</time_frame>
    <description>Percent of patients that have any amputation above the ankle of the study leg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>12 months</time_frame>
    <description>Percent of patients that exit due to death</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Critical Limb Ischemia</condition>
  <condition>Ischemia</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients assigned to the treatment arm will be injected with autologous concentrated total nucleated cells (TNCs) three times at six week intervals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline (Control Arm)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients assigned to the control arm will be injected with saline three times at six week intervals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HemaTrate™ Blood Filtration system</intervention_name>
    <description>Anticoagulated whole blood is loaded into the filtration system. During gravity filtration, the majority of platelets, plasma, and red blood cells pass through the filter into a filtrate bag. The TNCs are captured in the filter material and recovered via a back-flush with 0.9 % saline into a syringe.</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Normal (0.9%) saline</description>
    <arm_group_label>Saline (Control Arm)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Critical Limb Ischemia in the study leg with ischemic rest pain and/or ulcer/minor&#xD;
             tissue loss (Rutherford 4 or 5)&#xD;
&#xD;
          2. Previously failed an endovascular or surgical treatment of the study lower leg and is&#xD;
             not being considered for additional intervention within the next 3 months OR is&#xD;
             unsuitable for revascularization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Simultaneously participating in another investigational study (e.g., drug or device)&#xD;
&#xD;
          2. Pregnant or breastfeeding, or planning to become pregnant within the next 12 months&#xD;
&#xD;
          3. Major surgery (open cardiac, vascular, or abdominal procedure) within the past 90 days&#xD;
&#xD;
          4. Endovascular intervention within the past 30 days&#xD;
&#xD;
          5. Current dialysis, or expected to need dialysis within the next 12 months&#xD;
&#xD;
          6. Previous above the ankle amputation in the study leg&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bijan Modarai, PhD, FRCS</last_name>
    <role>Study Chair</role>
    <affiliation>St Thomas' Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Václav Procházka, MD, PhD, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Ostrava</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Giulio Pompilio, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Centro Cardiologico Monzino IRCCS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Manchester Royal Infirmary, Manchester Vascular Centre</name>
      <address>
        <city>Manchester</city>
        <state>Great Britian</state>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Leeds Teaching Hospital NHS Trust</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Czechia</country>
    <country>Poland</country>
  </removed_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>November 30, 2020</last_update_submitted>
  <last_update_submitted_qc>November 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lower extremity</keyword>
  <keyword>Peripheral Arterial Disease</keyword>
  <keyword>Ischemia</keyword>
  <keyword>Peripheral Blood Stem Cell Transplantation</keyword>
  <keyword>Leukocytes, Mononuclear</keyword>
  <keyword>Transplantation, Autologous</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Limb-Threatening Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the &quot;Cook Research Incorporated Policy on Access to Clinical Study Data&quot; at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.</ipd_description>
  </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/NCT03809494
org study id: 15-03
nct id: NCT03809494
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood
      Filtration system in the treatment of critical limb ischemia. The primary endpoint measure is
      comparing the percentage of patients between the treatment arm and control arm who have
      freedom from major amputation, arterial intervention below the knee, and death through 12
      months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: The investigator for this study is the person that will be performing the injections throughout the study and will know the participant's treatment (TNC or saline). The investigator that is aware of the participant's treatment will not be performing the follow-up visits.
measure: Freedom from vascular or endovascular arterial intervention below the knee of the study leg
time frame: 12 months
description: Percent of patients that have vascular or endovascular arterial intervention reported below the knee of the study leg
measure: Freedom from major amputation of the study leg
time frame: 12 months
description: Percent of patients that have any amputation above the ankle of the study leg
measure: Death
time frame: 12 months
description: Percent of patients that exit due to death
arm group label: Treatment Arm
arm group type: Experimental
description: Patients assigned to the treatment arm will be injected with autologous concentrated total nucleated cells (TNCs) three times at six week intervals.
arm group label: Saline (Control Arm)
arm group type: Placebo Comparator
description: Patients assigned to the control arm will be injected with saline three times at six week intervals.
intervention type: Device
intervention name: HemaTrate™ Blood Filtration system
description: Anticoagulated whole blood is loaded into the filtration system. During gravity filtration, the majority of platelets, plasma, and red blood cells pass through the filter into a filtrate bag. The TNCs are captured in the filter material and recovered via a back-flush with 0.9 % saline into a syringe.
arm group label: Treatment Arm
intervention type: Other
intervention name: Saline
description: Normal (0.9%) saline
arm group label: Saline (Control Arm)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Bijan Modarai, PhD, FRCS
role: Study Chair
affiliation: St Thomas' Hospital
last name: Václav Procházka, MD, PhD, MSc
role: Study Chair
affiliation: University Hospital Ostrava
last name: Giulio Pompilio, MD, PhD
role: Study Chair
affiliation: Centro Cardiologico Monzino IRCCS
facility: 
facility: 
facility: 
country: United Kingdom
country: Czechia
country: Poland
responsible party type: Sponsor
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia
sharing ipd: Undecided
ipd description: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.