<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/NCT04434586</url>
  </required_header>
  <id_info>
    <org_study_id>2018_88</org_study_id>
    <secondary_id>2019-A01055-52</secondary_id>
    <nct_id>NCT04434586</nct_id>
  </id_info>
  <brief_title>Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions</brief_title>
  <acronym>TOCAF</acronym>
  <official_title>Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</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>
      This is a common care study. A study for evaluating the quality of balloon inflation and&#xD;
      stent application will be performed in 2D angiography alone in the control group and then by&#xD;
      2D and OCT angiography for the experimental group. The benefit could be an improvement in the&#xD;
      results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D&#xD;
      visualization of the arterial lumen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary patency rate at 1 year.</measure>
    <time_frame>at 12 months (+/- 2months)</time_frame>
    <description>The permeability rate is defined by the echodoppler criteria: PVS&gt;2.4m/s or appearance of stenosis on the previously treated segment &gt;70%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary patency rate at 1 year.</measure>
    <time_frame>at 1month (+/- 10days), 6months (+/- 1month)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion revascularisation</measure>
    <time_frame>at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)</time_frame>
    <description>corresponds to the occurrence of a re-intervention on the treated segment to maintain or restore permeability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel revascularisation</measure>
    <time_frame>at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)</time_frame>
    <description>corresponds to the occurrence of a re-intervention on the previously treated artery, whatever the level, in order to maintain its permeability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cost-effectiveness analyses</measure>
    <time_frame>at 12 months (+/- 2months)</time_frame>
    <description>Cost-effectiveness analysis between 2 therapeutic strategies: The costs related to each strategy are calculated taking into account the direct and indirect costs.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rutherford scale considered ordinal variable</measure>
    <time_frame>at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)</time_frame>
    <description>Rutherford grade of 2-4 for their target leg. The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation).</description>
  </other_outcome>
  <other_outcome>
    <measure>Variation in Ankle Brachial Index between randomization and 1, 6, 12 months on the revascularized limb in the study.</measure>
    <time_frame>at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)</time_frame>
    <description>Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm</description>
  </other_outcome>
  <other_outcome>
    <measure>Variation in quality of life assessed by Walk Impairment Questionnary between randomization and 1, 6, 12 months.</measure>
    <time_frame>at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)</time_frame>
    <description>a questionnaire for evaluating walking impairment in patients&#xD;
Parameters:&#xD;
difficulty walking a distance during the past month&#xD;
difficulty walking at a certain speed during the past month&#xD;
symptoms associated with walking impairment</description>
  </other_outcome>
  <other_outcome>
    <measure>Variation in quality of life assessed by EQ5D scores between randomization and 1, 6, 12 months.</measure>
    <time_frame>at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)</time_frame>
    <description>overall score on a numeric scale &quot;check the box that best describes your health today&quot;, 5 themes (mobility, autonomy of the person, common activities, pain / discomfort, anxiety / depression)</description>
  </other_outcome>
  <other_outcome>
    <measure>Limb Rescue Rate</measure>
    <time_frame>at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">166</enrollment>
  <condition>Superficial Femoral Artery Stenosis</condition>
  <condition>Claudication</condition>
  <condition>Ischemic Leg</condition>
  <arm_group>
    <arm_group_label>angiography 2D</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Control group: an arteriography will be performed on the entire treated segment to assess the quality of the result, the application or not an active balloon will be left to the discretion of the operator. In case of application of the active balloon, a new arteriography before decision or not the use of stenting will be practiced. In case of stenting, an arteriographic final is performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>angiography 2D with OCT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group: an arteriography and OCT acquisition on the entire treated segment to ensure the quality of the result, the application or not of an active ball will be left. In case of application of the active balloon, a new arteriography and OCT acquisition before decision or not the use of stenting will be practiced. In case of stenting, a final arteriography and then OCT acquisition are performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>femoropopliteal revascularization for TASC C or TASC D lesion</intervention_name>
    <description>Femoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control</description>
    <arm_group_label>angiography 2D</arm_group_label>
    <arm_group_label>angiography 2D with OCT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 years old&#xD;
&#xD;
          -  Femoral-popliteal lesion TASC-C or TASC-D de novo (F1 to P1)&#xD;
&#xD;
          -  Starting lesion on the superficial femoral artery and not extending beyond the&#xD;
             intercondylar notch (P2)&#xD;
&#xD;
          -  ≥1 continuous permeable leg axis directly injecting the plantar arch&#xD;
&#xD;
          -  Rutherford 2-5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under personal protection regime (tutorship, guardianship)&#xD;
&#xD;
          -  Absence of arterial axis in permeable leg&#xD;
&#xD;
          -  Patient presenting a limb acute ischaemia (chart evolving since less than 14 days)&#xD;
&#xD;
          -  Patient without favorable element to consider healing&#xD;
&#xD;
          -  History of stents on the femoropopliteal axis&#xD;
&#xD;
          -  History of femoropopliteal bypass&#xD;
&#xD;
          -  Untreated stenosis ≥30% on the iliac axis and common femoral upstream&#xD;
&#xD;
          -  Popliteal lesion beyond the intercondylar notch (P2)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Sobocinski, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jonathan Sobocinski, MD,PhD</last_name>
    <phone>0320445911</phone>
    <email>jonathan.sobocinski@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Insitut Coeur-Poumon, CHU</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>0320445962</phone>
    </contact>
    <investigator>
      <last_name>Jonathan SOBOCINSKI, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>May 23, 2022</last_update_submitted>
  <last_update_submitted_qc>May 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>femoral recanalization</keyword>
  <keyword>optical coherence tomography (OCT)</keyword>
  <keyword>endovascular treatment</keyword>
  <keyword>TASC-C,</keyword>
  <keyword>TASC-D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intermittent Claudication</mesh_term>
  </condition_browse>
  <!-- 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/NCT04434586
org study id: 2018_88
secondary id: 2019-A01055-52
nct id: NCT04434586
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a common care study. A study for evaluating the quality of balloon inflation and
      stent application will be performed in 2D angiography alone in the control group and then by
      2D and OCT angiography for the experimental group. The benefit could be an improvement in the
      results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D
      visualization of the arterial lumen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Primary patency rate at 1 year.
time frame: at 12 months (+/- 2months)
description: The permeability rate is defined by the echodoppler criteria: PVS>2.4m/s or appearance of stenosis on the previously treated segment >70%.
measure: Primary patency rate at 1 year.
time frame: at 1month (+/- 10days), 6months (+/- 1month)
measure: Target lesion revascularisation
time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
description: corresponds to the occurrence of a re-intervention on the treated segment to maintain or restore permeability
measure: Target vessel revascularisation
time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
description: corresponds to the occurrence of a re-intervention on the previously treated artery, whatever the level, in order to maintain its permeability.
measure: cost-effectiveness analyses
time frame: at 12 months (+/- 2months)
description: Cost-effectiveness analysis between 2 therapeutic strategies: The costs related to each strategy are calculated taking into account the direct and indirect costs.
measure: Rutherford scale considered ordinal variable
time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
description: Rutherford grade of 2-4 for their target leg. The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation).
measure: Variation in Ankle Brachial Index between randomization and 1, 6, 12 months on the revascularized limb in the study.
time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
description: Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm
measure: Variation in quality of life assessed by Walk Impairment Questionnary between randomization and 1, 6, 12 months.
time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
description: a questionnaire for evaluating walking impairment in patients
Parameters:
difficulty walking a distance during the past month
difficulty walking at a certain speed during the past month
symptoms associated with walking impairment
measure: Variation in quality of life assessed by EQ5D scores between randomization and 1, 6, 12 months.
time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
description: overall score on a numeric scale "check the box that best describes your health today", 5 themes (mobility, autonomy of the person, common activities, pain / discomfort, anxiety / depression)
measure: Limb Rescue Rate
time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
arm group label: angiography 2D
arm group type: Sham Comparator
description: Control group: an arteriography will be performed on the entire treated segment to assess the quality of the result, the application or not an active balloon will be left to the discretion of the operator. In case of application of the active balloon, a new arteriography before decision or not the use of stenting will be practiced. In case of stenting, an arteriographic final is performed.
arm group label: angiography 2D with OCT
arm group type: Experimental
description: Experimental group: an arteriography and OCT acquisition on the entire treated segment to ensure the quality of the result, the application or not of an active ball will be left. In case of application of the active balloon, a new arteriography and OCT acquisition before decision or not the use of stenting will be practiced. In case of stenting, a final arteriography and then OCT acquisition are performed.
intervention type: Device
intervention name: femoropopliteal revascularization for TASC C or TASC D lesion
description: Femoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control
arm group label: angiography 2D
arm group label: angiography 2D with OCT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jonathan Sobocinski, MD,PhD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Jonathan Sobocinski, MD,PhD
phone: 0320445911
email: jonathan.sobocinski@chru-lille.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Intermittent Claudication