<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/NCT03293589</url>
  </required_header>
  <id_info>
    <org_study_id>00042158</org_study_id>
    <nct_id>NCT03293589</nct_id>
  </id_info>
  <brief_title>Open Versus Endovascular Revascularization in Patients With End-stage Renal Disease</brief_title>
  <acronym>OERESRD</acronym>
  <official_title>Open Versus Endovascular Revascularization of Below-knee Arteries in Patients With End-stage Renal Disease and Critical Limb Ischemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Erlangen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Erlangen</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>
      Treatment of patients with end-stage renal disease and critical limb ischemia still poses&#xD;
      challenges to vascular medicine due to limited survival, comorbidities and infrapopliteal&#xD;
      involvement of arteriosclerosis in these patients.&#xD;
&#xD;
      Most optimal vascular therapy mode has not been finally decided in these patients.&#xD;
&#xD;
      Therefore retrospective analysis of patients receiving open surgical and endovascular&#xD;
      revascularisation was performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Query of internal clinical database for identification of patients (2009-2017)with end-stage&#xD;
      renal disease and critical limb ischemia, receiving either open surgical (Group I &quot;OR&quot;) or&#xD;
      endovascular revascularisation (Group II &quot;EVT&quot;).&#xD;
&#xD;
      Furthermore, retrospective comparison as to morphological criteria (lesion length, peripheral&#xD;
      run-off, plantar arch) and comorbidities.&#xD;
&#xD;
      Prospective follow-up of identified patients by means of telephone contacts and/or clinical&#xD;
      examination of evaluation of Long-term outcome measures (Overall survival, Amputation-free&#xD;
      survival, wound healing)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">October 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 20, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Amputation free survival</measure>
    <time_frame>24 months</time_frame>
    <description>Evaluation of limb salvage and survival as Composite endpoint</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>24 months</time_frame>
    <description>Evaluation of Overall survival rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Amputation</measure>
    <time_frame>24 months</time_frame>
    <description>Evaluation of Major Amputation rate</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">77</enrollment>
  <condition>End-stage Renal Disease</condition>
  <condition>Critical Limb Ischemia</condition>
  <arm_group>
    <arm_group_label>OR</arm_group_label>
    <description>patients treated with open revascularization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EVT</arm_group_label>
    <description>patients treated with endovascular revascularization</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>open revascularization</intervention_name>
    <description>surgical revascularization (i.e. Bypass surgery)</description>
    <arm_group_label>OR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endovascular revascularization</intervention_name>
    <description>endovascular revascularization (stent, ballon angioplasty)</description>
    <arm_group_label>EVT</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        study Population comprises of all dialysis patients treated for critical limb ischemia by&#xD;
        means of surgical or endiovascular Intervention at University Hospital Erlangen between&#xD;
        2009 and 2017&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of end-stage renal disease&#xD;
&#xD;
          -  presence of critical limb ischemia (Ankle-brachial-index &gt; 0.4 or presence of rest&#xD;
             pain or ischemic ulcers or gangrene)&#xD;
&#xD;
          -  revascularisation by means of Bypass or endovascular therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  conservative Treatment&#xD;
&#xD;
          -  non-atherosclerotic lesions&#xD;
&#xD;
          -  coagulation disorders&#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>Alexander Meyer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Erlangen, Department of Vascular Sugery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Erlangen</city>
        <state>Bavaria</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>March 25, 2020</last_update_submitted>
  <last_update_submitted_qc>March 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Erlangen</investigator_affiliation>
    <investigator_full_name>Alexander Meyer, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>end-stage renal disease</keyword>
  <keyword>critical limb ischemia</keyword>
  <keyword>surgical revascularisation</keyword>
  <keyword>endovascular therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <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/NCT03293589
org study id: 00042158
nct id: NCT03293589
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Treatment of patients with end-stage renal disease and critical limb ischemia still poses
      challenges to vascular medicine due to limited survival, comorbidities and infrapopliteal
      involvement of arteriosclerosis in these patients.

      Most optimal vascular therapy mode has not been finally decided in these patients.

      Therefore retrospective analysis of patients receiving open surgical and endovascular
      revascularisation was performed.
Query of internal clinical database for identification of patients (2009-2017)with end-stage
      renal disease and critical limb ischemia, receiving either open surgical (Group I "OR") or
      endovascular revascularisation (Group II "EVT").

      Furthermore, retrospective comparison as to morphological criteria (lesion length, peripheral
      run-off, plantar arch) and comorbidities.

      Prospective follow-up of identified patients by means of telephone contacts and/or clinical
      examination of evaluation of Long-term outcome measures (Overall survival, Amputation-free
      survival, wound healing)
observational model: Cohort
time perspective: Retrospective
measure: Amputation free survival
time frame: 24 months
description: Evaluation of limb salvage and survival as Composite endpoint
measure: Overall survival
time frame: 24 months
description: Evaluation of Overall survival rate
measure: Major Amputation
time frame: 24 months
description: Evaluation of Major Amputation rate
arm group label: OR
description: patients treated with open revascularization
arm group label: EVT
description: patients treated with endovascular revascularization
intervention type: Procedure
intervention name: open revascularization
description: surgical revascularization (i.e. Bypass surgery)
arm group label: OR
intervention type: Procedure
intervention name: endovascular revascularization
description: endovascular revascularization (stent, ballon angioplasty)
arm group label: EVT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Alexander Meyer, MD
role: Principal Investigator
affiliation: University Hospital Erlangen, Department of Vascular Sugery
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Erlangen
investigator full name: Alexander Meyer, MD
investigator title: MD
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Ischemia
sharing ipd: No