<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/NCT03295539</url>
  </required_header>
  <id_info>
    <org_study_id>Indigo2017</org_study_id>
    <nct_id>NCT03295539</nct_id>
  </id_info>
  <brief_title>Acute Limb Ischaemia (ALI) Management With 'Indigo' Mechanical Aspiration System</brief_title>
  <official_title>MulticentRe pOst-market exPeriencE With the INdigo Thrombectomy System for the Treatment of Acute Lower Limb Ischaemia : (Re-Open Registry)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lancashire Care NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Franziskus Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lancashire Care NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      International Multi-Centre registry recording comprehensive data on the use of 'Indigo'&#xD;
      Mechanical thrombectomy system by Penumbra Inc for the removal of acute clot causing acute or&#xD;
      critical limb ischaemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A detailed registry has been designed and approved to be used world wide in vascular and&#xD;
      trauma centres, already providing endovascular service for the management of critical limb&#xD;
      ischaemia (CLI).&#xD;
&#xD;
      Recent campaigns have shown little is done to improve flow to the lower limbs (legs) of&#xD;
      patients to avoid amputation rates. During this time many devises have been used and&#xD;
      available on the market. The 'Indigo' system by Penumbra was originally designed from the&#xD;
      acute stroke system &quot;ACE&quot;. Similar principles were applied in designing the 'Indigo' system.&#xD;
      This is currently being used in many centres to manage acute clot causing lower limb&#xD;
      ischaemia, however no official registry or international clinical trial has been done to show&#xD;
      its significance in managing this disease.&#xD;
&#xD;
      The investigator groups, have created this to come up with enough data to evaluate the Indigo&#xD;
      system in the management of (ALI) and offer tips and tricks to other clinicians. The aim is&#xD;
      for a single arm, multicenter, retrospective analysis of patients in whom (ALI) was performed&#xD;
      with the Penumbra/Indigo System (study device), and gather greater data and information than&#xD;
      the PRISM trial in 2013-2014 which obtained only 79 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Technical success using the Indigo system.</measure>
    <time_frame>Time to event anaylsis. Primary patency results are immediate after the case on the final angiogram images.</time_frame>
    <description>Intraoperative technical success defined as the restoration of antegrade blood flow with complete or near complete (95% by volume) removal of the thrombus or embolus (70% threshold). This is assessed using imaging modalities (USS/Doppler/Fluroscopy) and clinical assessment of the affected limb.&#xD;
See for this definition the enclosed citation. In conclusion, the primary outcome measure will be improvement in blood flow across a lesion assessed by the improvement in Thrombolysis in Myocardial Infarction (TIMI) score that was adapted to peripheral arteries. Concomitant balloon angioplasty or stent placement in addition to VAT was considered a complementary treatment. Additional thrombectomy treatments, such as thrombolysis and mechanical thrombectomy, were considered technical failures.Target lesions were grouped anatomically into above-the-knee(ATK) or below-the-knee(BTK) lesions.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Lower Limb Ischemia</condition>
  <arm_group>
    <arm_group_label>Acute or Chronic clot</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>If chronic clot, no intervention given via Indigo</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>'Indigo' Mechanical thrombectomy system</intervention_name>
    <description>Removal of acute clot from the artery causing ischaemia, using the mechanical aspiration system by Penumbra Inc called &quot;INDIGO&quot;</description>
    <arm_group_label>Acute or Chronic clot</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute lower limb Ischaemia with acute soft clot.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Calcified plaques/ chronic disease causing critical limb Ischaemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bella Huasen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Lancashire NHS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bella Huasen, MD</last_name>
    <phone>00447871800565</phone>
    <email>doctorbella.h@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Theo Bisdas, Phd, MD</last_name>
    <phone>00492519355829</phone>
    <email>th.bisdas@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Interventional Radiology</name>
      <address>
        <city>Preston</city>
        <state>Lancashire</state>
        <zip>PR2 7HR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>BELLA HUASEN, MD</last_name>
      <phone>00447871800565</phone>
      <email>doctorbella.h@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Karnabatidis D, Spiliopoulos S, Tsetis D, Siablis D. Quality improvement guidelines for percutaneous catheter-directed intra-arterial thrombolysis and mechanical thrombectomy for acute lower-limb ischemia. Cardiovasc Intervent Radiol. 2011 Dec;34(6):1123-36. doi: 10.1007/s00270-011-0258-z. Epub 2011 Sep 1.</citation>
    <PMID>21882081</PMID>
  </results_reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>October 19, 2017</last_update_submitted>
  <last_update_submitted_qc>October 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lancashire Care NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Bella Huasen</investigator_full_name>
    <investigator_title>Endovascular Interventional Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The registry and data in-put</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>while the study is on-going</ipd_time_frame>
    <ipd_access_criteria>Centres taking part will be given the access via the three main trial investigators Dr Huasen, Dr Bisdas, and Dr Beropoulis</ipd_access_criteria>
  </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/NCT03295539
org study id: Indigo2017
nct id: NCT03295539
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
International Multi-Centre registry recording comprehensive data on the use of 'Indigo'
      Mechanical thrombectomy system by Penumbra Inc for the removal of acute clot causing acute or
      critical limb ischaemia.
A detailed registry has been designed and approved to be used world wide in vascular and
      trauma centres, already providing endovascular service for the management of critical limb
      ischaemia (CLI).

      Recent campaigns have shown little is done to improve flow to the lower limbs (legs) of
      patients to avoid amputation rates. During this time many devises have been used and
      available on the market. The 'Indigo' system by Penumbra was originally designed from the
      acute stroke system "ACE". Similar principles were applied in designing the 'Indigo' system.
      This is currently being used in many centres to manage acute clot causing lower limb
      ischaemia, however no official registry or international clinical trial has been done to show
      its significance in managing this disease.

      The investigator groups, have created this to come up with enough data to evaluate the Indigo
      system in the management of (ALI) and offer tips and tricks to other clinicians. The aim is
      for a single arm, multicenter, retrospective analysis of patients in whom (ALI) was performed
      with the Penumbra/Indigo System (study device), and gather greater data and information than
      the PRISM trial in 2013-2014 which obtained only 79 patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Technical success using the Indigo system.
time frame: Time to event anaylsis. Primary patency results are immediate after the case on the final angiogram images.
description: Intraoperative technical success defined as the restoration of antegrade blood flow with complete or near complete (95% by volume) removal of the thrombus or embolus (70% threshold). This is assessed using imaging modalities (USS/Doppler/Fluroscopy) and clinical assessment of the affected limb.
See for this definition the enclosed citation. In conclusion, the primary outcome measure will be improvement in blood flow across a lesion assessed by the improvement in Thrombolysis in Myocardial Infarction (TIMI) score that was adapted to peripheral arteries. Concomitant balloon angioplasty or stent placement in addition to VAT was considered a complementary treatment. Additional thrombectomy treatments, such as thrombolysis and mechanical thrombectomy, were considered technical failures.Target lesions were grouped anatomically into above-the-knee(ATK) or below-the-knee(BTK) lesions.
arm group label: Acute or Chronic clot
arm group type: Other
description: If chronic clot, no intervention given via Indigo
intervention type: Device
intervention name: 'Indigo' Mechanical thrombectomy system
description: Removal of acute clot from the artery causing ischaemia, using the mechanical aspiration system by Penumbra Inc called "INDIGO"
arm group label: Acute or Chronic clot
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bella Huasen, MD
role: Study Chair
affiliation: Lancashire NHS
last name: Bella Huasen, MD
phone: 00447871800565
email: doctorbella.h@gmail.com
last name: Theo Bisdas, Phd, MD
phone: 00492519355829
email: th.bisdas@gmail.com
facility: 
contact: 
country: United Kingdom
citation: Karnabatidis D, Spiliopoulos S, Tsetis D, Siablis D. Quality improvement guidelines for percutaneous catheter-directed intra-arterial thrombolysis and mechanical thrombectomy for acute lower-limb ischemia. Cardiovasc Intervent Radiol. 2011 Dec;34(6):1123-36. doi: 10.1007/s00270-011-0258-z. Epub 2011 Sep 1.
PMID: 21882081
responsible party type: Principal Investigator
investigator affiliation: Lancashire Care NHS Foundation Trust
investigator full name: Bella Huasen
investigator title: Endovascular Interventional Consultant
mesh term: Ischemia
sharing ipd: Yes
ipd description: The registry and data in-put
ipd info type: Study Protocol
ipd time frame: while the study is on-going
ipd access criteria: Centres taking part will be given the access via the three main trial investigators Dr Huasen, Dr Bisdas, and Dr Beropoulis