<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/NCT03026049</url>
  </required_header>
  <id_info>
    <org_study_id>RCT DVO</org_study_id>
    <nct_id>NCT03026049</nct_id>
  </id_info>
  <brief_title>Stent Versus Conservative Treatment in Patients With Deep Venous Obstruction</brief_title>
  <acronym>STEVECO</acronym>
  <official_title>A Randomized Controlled Trial Comparing Venous Stenting With Conservative Treatment in Patients With Deep Venous Obstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Patients will be randomised between deep venous stenting or conservative management&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    it was not possible to recruit the required amount of participants within a reseanable&#xD;
    timefram.&#xD;
  </why_stopped>
  <start_date type="Actual">March 9, 2017</start_date>
  <completion_date type="Actual">October 7, 2021</completion_date>
  <primary_completion_date type="Actual">October 7, 2021</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life score</measure>
    <time_frame>12 months</time_frame>
    <description>Quality of Life score</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Deep-Venous Thrombosis</condition>
  <condition>Deep Venous Stenting</condition>
  <condition>Randomized Clinical Trial</condition>
  <arm_group>
    <arm_group_label>deep venous stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive deep venous stenting in the iliaco(femoral) region</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conservative managment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Conservative management of complaints</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>deep venous stenting</intervention_name>
    <description>Deep venous stent</description>
    <arm_group_label>deep venous stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Meet criteria for PTS or&#xD;
&#xD;
          -  Patients with May Thurner syndrome on additional imaging&#xD;
&#xD;
          -  Life expectancy of more than one year&#xD;
&#xD;
          -  Deep venous thrombosis &gt; 1 year&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous intervention of central veins (inferior vena cava, iliac veins, common&#xD;
             femoral vein) on the affected limb&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Inability to answer Dutch QoL questionnaires or limited communication in Dutch&#xD;
             (written and spoken)&#xD;
&#xD;
          -  Contra-indication for prolonged anticoagulant treatment&#xD;
&#xD;
          -  Recent, &lt;1 year, deep venous thrombosis or pulmonary Embolism&#xD;
&#xD;
          -  Known contrast allergy&#xD;
&#xD;
          -  Known dialysis or renal insufficiency needing additional preparation for injection of&#xD;
             contrast&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Maastricht university medical center</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>March 31, 2022</last_update_submitted>
  <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2022</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>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</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/NCT03026049
org study id: RCT DVO
nct id: NCT03026049
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients will be randomised between deep venous stenting or conservative management
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Quality of Life score
time frame: 12 months
description: Quality of Life score
arm group label: deep venous stent
arm group type: Active Comparator
description: Patients will receive deep venous stenting in the iliaco(femoral) region
arm group label: conservative managment
arm group type: No Intervention
description: Conservative management of complaints
intervention type: Device
intervention name: deep venous stenting
description: Deep venous stent
arm group label: deep venous stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Venous Thrombosis