<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/NCT02198612</url>
  </required_header>
  <id_info>
    <org_study_id>RC14_0226</org_study_id>
    <nct_id>NCT02198612</nct_id>
  </id_info>
  <brief_title>FREEDOM: &quot;Pilot Study of the Feasibility and Safety of Resuming Early Walking After Manual Compression in Patients Treated for Peripheral Artery Disease by Endovascular Technique Involving Retrograde Femoral Puncture&quot;</brief_title>
  <acronym>FREEDOM</acronym>
  <official_title>FREEDOM: &quot;Pilot Study of the Feasibility and Safety of Resuming Early Walking After Manual Compression in Patients Treated for Peripheral Artery Disease by Endovascular Technique Involving Retrograde Femoral Puncture&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over the past years, arterial closure systems have tended to replace manual compression to&#xD;
      ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce&#xD;
      hemostasis and patient immobilization times, thus enabling early resumption of walking. These&#xD;
      devices have contributed extensively to the development of outpatient stays for cardiology,&#xD;
      vascular and neuro-radiology procedures.&#xD;
&#xD;
      According to certain studies however, it would appear that arterial closure devices do not&#xD;
      present any greater benefits than manual compression in terms of hemostasis and&#xD;
      complications. Moreover, the use of increasingly small diameter instruments would tend to&#xD;
      render manual compression sufficient. Finally, the use of these devices generates additional&#xD;
      costs.&#xD;
&#xD;
      The purpose of our study is to evaluate the feasibility and safety of manual compression&#xD;
      before early resumption of walking in patients managed by conventional hospitalization for a&#xD;
      diagnostic or therapeutic endovascular procedures by retrograde femoral puncture with 5F&#xD;
      guide catheter.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resumption of walking at H5 will be evaluated by a walking test</measure>
    <time_frame>Hour 5</time_frame>
    <description>To demonstrate the feasibility of early resumption of walking after manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of major punctured femoral triangle events during the perioperative period, requiring prolongation of hospitalization, repeat hospitalization or repeat surgery (hematoma, hemorrhage or false aneurysm)</measure>
    <time_frame>Hour 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of minor punctured femoral triangle events during the perioperative period, not requiring prolongation of hospitalization, repeat hospitalization or repeat surgery</measure>
    <time_frame>Hour 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to onset of complications</measure>
    <time_frame>Hour 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Puncture point pain (visual analog scale of pain)</measure>
    <time_frame>Hour 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life evaluation (EQ5D questionnaire)</measure>
    <time_frame>Month 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compression time</measure>
    <time_frame>Hour 5</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Manual puncture point compression</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual puncture point compression</intervention_name>
    <description>Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter</description>
    <arm_group_label>Manual puncture point compression</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years,&#xD;
&#xD;
          -  Endovascular examination or treatment compatible with a 5F guide catheter&#xD;
&#xD;
          -  Walking ability&#xD;
&#xD;
          -  Patient affiliated with a social security scheme&#xD;
&#xD;
          -  Patient's signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Underage patient&#xD;
&#xD;
          -  Patient of age, but under legal guardianship or care&#xD;
&#xD;
          -  Contraindication to endovascular treatment&#xD;
&#xD;
          -  Use of a 6F or greater guide catheter&#xD;
&#xD;
          -  Morbidity contraindicating same-day walking&#xD;
&#xD;
          -  History of punctured open femoral triangle surgery&#xD;
&#xD;
          -  Radial or humeral puncture&#xD;
&#xD;
          -  Bilateral femoral puncture&#xD;
&#xD;
          -  Anterograde femoral puncture&#xD;
&#xD;
          -  Acute ischemia&#xD;
&#xD;
          -  Anticoagulant treatment&#xD;
&#xD;
          -  Allergy to Elastoplast® type adhesive strips&#xD;
&#xD;
          -  Life expectancy of less than one month&#xD;
&#xD;
          -  Patient refusal to take part in the study&#xD;
&#xD;
          -  Participation in another therapeutic trial&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Patients who do not speak French, refusing or incapable of the follow-up proposed by&#xD;
             the study&#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>Yann GOUEFFIC, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Nantes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>December 22, 2015</last_update_submitted>
  <last_update_submitted_qc>December 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2015</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>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</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/NCT02198612
org study id: RC14_0226
nct id: NCT02198612
lead sponsor: 
has dmc: No
Over the past years, arterial closure systems have tended to replace manual compression to
      ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce
      hemostasis and patient immobilization times, thus enabling early resumption of walking. These
      devices have contributed extensively to the development of outpatient stays for cardiology,
      vascular and neuro-radiology procedures.

      According to certain studies however, it would appear that arterial closure devices do not
      present any greater benefits than manual compression in terms of hemostasis and
      complications. Moreover, the use of increasingly small diameter instruments would tend to
      render manual compression sufficient. Finally, the use of these devices generates additional
      costs.

      The purpose of our study is to evaluate the feasibility and safety of manual compression
      before early resumption of walking in patients managed by conventional hospitalization for a
      diagnostic or therapeutic endovascular procedures by retrograde femoral puncture with 5F
      guide catheter.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Resumption of walking at H5 will be evaluated by a walking test
time frame: Hour 5
description: To demonstrate the feasibility of early resumption of walking after manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter.
measure: Occurrence of major punctured femoral triangle events during the perioperative period, requiring prolongation of hospitalization, repeat hospitalization or repeat surgery (hematoma, hemorrhage or false aneurysm)
time frame: Hour 5
measure: Occurrence of minor punctured femoral triangle events during the perioperative period, not requiring prolongation of hospitalization, repeat hospitalization or repeat surgery
time frame: Hour 5
measure: Time to onset of complications
time frame: Hour 5
measure: Puncture point pain (visual analog scale of pain)
time frame: Hour 5
measure: Quality of life evaluation (EQ5D questionnaire)
time frame: Month 1
measure: Compression time
time frame: Hour 5
arm group label: Manual puncture point compression
arm group type: Other
description: Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter
intervention type: Other
intervention name: Manual puncture point compression
description: Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter
arm group label: Manual puncture point compression
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yann GOUEFFIC, Professor
role: Study Chair
affiliation: Nantes University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases