<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/NCT03772821</url>
  </required_header>
  <id_info>
    <org_study_id>STEINMETZ 2018</org_study_id>
    <nct_id>NCT03772821</nct_id>
  </id_info>
  <brief_title>Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery</brief_title>
  <acronym>PROFA</acronym>
  <official_title>Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery: Prospective Multicenter Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      No prospective study has yet evaluated the factors influencing the complications of femoral&#xD;
      bifurcation surgery in France. Daily practice of investigators suggests that conventional&#xD;
      surgical treatment has had a higher rate of local complications in recent years for a variety&#xD;
      of reasons that remain to be assessed (aging, overweight, chronic renal failure, diabetes, or&#xD;
      other), but as of yet, investigators do not have proof of such an effect. The proposed study&#xD;
      would follow a prospective, continuous, multicentre cohort of patients to describe the type,&#xD;
      frequency and factors that contribute to local and general complications of surgery on the&#xD;
      femoral bifurcation. This information is essential in the choice of the best&#xD;
      revascularization technique for the femoral artery, which is frequently the site used for&#xD;
      interventions in vascular conditions.&#xD;
&#xD;
      Surgeries will be performed in the normal manner. The research will be based on medical data&#xD;
      collected during patient management. A measurement of the incision/scar will be taken once&#xD;
      the procedure has been performed, either immediately after surgery or after a period of time,&#xD;
      during post-operative consultation. Participation in this research will last 3 months from&#xD;
      the day of the intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of at least one of the following local complications: dehiscence alone, dehiscence with infection, superficial infection, deep infection, other (lymphorrhea, hematoma, lymphocele)</measure>
    <time_frame>Between Day 0 and Day 90</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">690</enrollment>
  <condition>Femoral Bifurcation Surgery</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>Between D0 and D90: local and general complications, demographic, clinical, paraclinical and biological data</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Incision/scar measurement</intervention_name>
    <description>Between D0 and D90</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a surgical approach to the common femoral artery or femoral tripod&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who has not opposed participation in the study&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  All patients with an open surgical approach to the common femoral artery and/or&#xD;
             femoral bifurcation, uni or bilateral, with or without endovascular or open procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with homolateral surgery of the femoral triangle which has not yet healed&#xD;
&#xD;
          -  Person subject to court-ordered protection (curatorship, guardianship)&#xD;
&#xD;
          -  Pregnant, parturient or breastfeeding woman&#xD;
&#xD;
          -  Adult unable to consent&#xD;
&#xD;
          -  Patient who refuses to participate in 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_contact>
    <last_name>Eric STEINMETZ</last_name>
    <phone>03 80 29 33 52</phone>
    <email>eric.steinmetz@chu-dijon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aline JAZAYERI</last_name>
    <email>aline.laubriet@chu-dijon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simon RINCKENBACH</last_name>
      <phone>03 81 66 82 27</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Colmar</name>
      <address>
        <city>Colmar</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benjamin KRETZ</last_name>
      <phone>03 89 12 44 77</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric STEINMETZ</last_name>
      <phone>03 80 29 33 52</phone>
      <email>eric.steinmetz@chu-dijon.fr</email>
    </contact>
    <contact_backup>
      <last_name>Aline JAZAYERI</last_name>
      <email>aline.laubriet@chu-dijon.fr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>GHR Mulhouse</name>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Afif GHASSANI</last_name>
      <phone>03 89 64 64 64</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Mâcon</name>
      <address>
        <city>Mâcon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas CHRETIEN</last_name>
      <phone>07 87 23 94 53</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Nancy</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicla SETTEMBRE</last_name>
      <phone>03 83 15 43 84</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Troyes</name>
      <address>
        <city>Troyes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier MAHMANDAR</last_name>
      <phone>03 25 49 49 55</phone>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>January 20, 2020</last_update_submitted>
  <last_update_submitted_qc>January 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03772821
org study id: STEINMETZ 2018
nct id: NCT03772821
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
No prospective study has yet evaluated the factors influencing the complications of femoral
      bifurcation surgery in France. Daily practice of investigators suggests that conventional
      surgical treatment has had a higher rate of local complications in recent years for a variety
      of reasons that remain to be assessed (aging, overweight, chronic renal failure, diabetes, or
      other), but as of yet, investigators do not have proof of such an effect. The proposed study
      would follow a prospective, continuous, multicentre cohort of patients to describe the type,
      frequency and factors that contribute to local and general complications of surgery on the
      femoral bifurcation. This information is essential in the choice of the best
      revascularization technique for the femoral artery, which is frequently the site used for
      interventions in vascular conditions.

      Surgeries will be performed in the normal manner. The research will be based on medical data
      collected during patient management. A measurement of the incision/scar will be taken once
      the procedure has been performed, either immediately after surgery or after a period of time,
      during post-operative consultation. Participation in this research will last 3 months from
      the day of the intervention.
observational model: Cohort
time perspective: Prospective
measure: Presence of at least one of the following local complications: dehiscence alone, dehiscence with infection, superficial infection, deep infection, other (lymphorrhea, hematoma, lymphocele)
time frame: Between Day 0 and Day 90
intervention type: Other
intervention name: Data collection
description: Between D0 and D90: local and general complications, demographic, clinical, paraclinical and biological data
intervention type: Other
intervention name: Incision/scar measurement
description: Between D0 and D90
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric STEINMETZ
phone: 03 80 29 33 52
email: eric.steinmetz@chu-dijon.fr
last name: Aline JAZAYERI
email: aline.laubriet@chu-dijon.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor