<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/NCT04490408</url>
  </required_header>
  <id_info>
    <org_study_id>EBRN71</org_study_id>
    <nct_id>NCT04490408</nct_id>
  </id_info>
  <brief_title>Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia</brief_title>
  <official_title>Long Surgical Bypass Versus Hybrid Approaches for Management of Critical Limb Ischemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Egyptian Biomedical Research Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Egyptian Biomedical Research Network</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>
      The present randomized study proposed to compare the immediate postoperative and 2-year&#xD;
      clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel&#xD;
      critical lower limb ischemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2014</start_date>
  <completion_date type="Actual">April 17, 2019</completion_date>
  <primary_completion_date type="Actual">April 17, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Late occlusion</measure>
    <time_frame>2 years</time_frame>
    <description>Late occlusion of the affected vessels</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Critical Lower Limb Ischemia</condition>
  <arm_group>
    <arm_group_label>long surgical bypass</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>long surgical bypass for multilevel lower limb ischemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hybrid approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>surgical bypass and endovascular treatment for multilevel lower limb ischemia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>long surgical bypass</intervention_name>
    <description>long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.</description>
    <arm_group_label>long surgical bypass</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hybrid approach</intervention_name>
    <description>Hybrid approach including bypass and endovascular revascularization</description>
    <arm_group_label>Hybrid approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  TASC II type D femoropopliteal lesions with intact ipsilateral femoral pulse.&#xD;
&#xD;
          -  Fontaine classification stage IV (gangrene or necrosis).&#xD;
&#xD;
          -  Rutherford grade III and IV category 5 and 6 with salvageable foot&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  heart failure&#xD;
&#xD;
          -  liver failure&#xD;
&#xD;
          -  renal impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>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/NCT04490408
org study id: EBRN71
nct id: NCT04490408
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present randomized study proposed to compare the immediate postoperative and 2-year
      clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel
      critical lower limb ischemia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Late occlusion
time frame: 2 years
description: Late occlusion of the affected vessels
arm group label: long surgical bypass
arm group type: Active Comparator
description: long surgical bypass for multilevel lower limb ischemia
arm group label: Hybrid approach
arm group type: Experimental
description: surgical bypass and endovascular treatment for multilevel lower limb ischemia
intervention type: Procedure
intervention name: long surgical bypass
description: long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.
arm group label: long surgical bypass
intervention type: Procedure
intervention name: Hybrid approach
description: Hybrid approach including bypass and endovascular revascularization
arm group label: Hybrid approach
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia
sharing ipd: No