<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/NCT02240914</url>
  </required_header>
  <id_info>
    <org_study_id>IDPC_ 4 2014</org_study_id>
    <nct_id>NCT02240914</nct_id>
  </id_info>
  <brief_title>Vascular Ultrasound Versus Intravascular Ultrasound for Diagnosing Iliac Vein Obstruction</brief_title>
  <acronym>USG-DIVO</acronym>
  <official_title>Prospective, Single-arm, Single Center, Pilot Study of Vascular Ultrasound Imaging Used as an Adjunct to Intravascular Ultrasound for Diagnosing Iliac Vein Obstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fabio H Rossi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto Dante Pazzanese de Cardiologia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Dante Pazzanese de Cardiologia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Determine the sensitivity, specificity and accuracy of vascular ultrasound, using direct&#xD;
           and indirect ultrasonographic signs, in the obstructive diseases of iliac venous&#xD;
           segment, in patients with advanced chronic venous insufficiency (CEAP 3-6), considering&#xD;
           the intravascular ultrasound (IVUS) as the gold standard for this diagnosis.&#xD;
&#xD;
        -  Develop an algorithm for noninvasive ultrasound investigation of obstructive lesions in&#xD;
           the iliac segment in patients with advanced chronic venous insufficiency (CEAP 3-6).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>A composite of direct and indirect ultrasonographic signs as a measure of iliac vein stenosis</measure>
    <time_frame>within 15 days</time_frame>
    <description>• 50 patients with Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification C3-6 undergoing iliac and common femoral vascular ultrasound imaging with intention to detect significative iliac vein obstructions ( &gt; 50%) and this results will be compared with the gold standard method - IVUS. Primary Endpoints: venous imaging in B- mode, volume flow and expiratory velocity in femoral vein, and the velocity relation before and through the stenosis provided by vascular ultrasound will be analyzed. Venous IVUS will provide measurements of minimum and maximum diameter reduction due to iliofemoral venous obstruction/compression; cross-sectional area reduction will also be measured.&#xD;
The percentage of significant stenosis detected at various thresholds [ &lt; 50%, 50-80%,&gt; 80%] with each method will be compared in a pair-wise fashion. This will be done with descriptive statistics of the detection rates for each method, and the rate of discordance between the two.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Iliac Vein Obstruction</condition>
  <condition>May-Thurner Syndrome</condition>
  <condition>Cockett Syndrome</condition>
  <arm_group>
    <arm_group_label>Vascular USG and IVUS imaging diagnosis</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with iliac compression disease CEAP classification 3-6.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced Chronic Venous Insufficiency (CEAP 3-6) submitted to clinical treatment for&#xD;
             at least 1 year with no response.&#xD;
&#xD;
          -  Subject must be &gt; 18 and &lt; 80 years of age&#xD;
&#xD;
          -  Willing to participate in and able to understand, read and sign the informed consent&#xD;
             document before the planned procedure&#xD;
&#xD;
          -  On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or&#xD;
             femoral vein of the study leg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject cannot or will not provide written informed consent&#xD;
&#xD;
          -  Previous venous stent implantation involving the study leg or inferior vena cava&#xD;
&#xD;
          -  Previous venovenous bypass surgery involving the study leg&#xD;
&#xD;
          -  Known reaction or sensitivity to iodinated contrast that cannot be managed with&#xD;
             premedication&#xD;
&#xD;
          -  Subjects who are pregnant (women of childbearing potential must have a negative&#xD;
             pregnancy test within 7 days prior to enrollment&#xD;
&#xD;
          -  Acute deep venous thrombosis involving either leg&#xD;
&#xD;
          -  Known history of chronic total occlusion of the common femoral vein of the study leg.&#xD;
&#xD;
          -  Known history of thrombophilia (e.g., protein C or S deficiency, anti-thrombin III&#xD;
             deficiency, presence of lupus anticoagulant, etc.)&#xD;
&#xD;
          -  Venous compression caused by tumor encasement&#xD;
&#xD;
          -  Venous outflow obstruction caused by tumor thrombus&#xD;
&#xD;
          -  Life expectancy of less than 6 months&#xD;
&#xD;
          -  Lower Extremity Arterial Insufficiency&#xD;
&#xD;
          -  Elevated baseline blood creatinine (value greater than the upper limit of the normal&#xD;
             range)&#xD;
&#xD;
          -  Any concurrent disease or condition that, in the opinion of the Investigator, would&#xD;
             make the subject unsuitable for participation in the study; examples include but are&#xD;
             not limited to the inability to lie supine for the index procedure (e.g., severe&#xD;
             congestive heart failure), thrombocytopenia or other hematological disorders&#xD;
             associated with an unacceptable risk of bleeding, implanted orthopedic hardware that&#xD;
             precludes proper imaging, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick B Metzger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vascular Surgeon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Dante Pazzanese de Cardiologia</name>
      <address>
        <city>São Paulo</city>
        <zip>04012-909</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick B Metzger, MD</last_name>
      <phone>(011)50856060</phone>
      <phone_ext>55</phone_ext>
      <email>patrickvascular@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Patrick B Metzger, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>MAY R, THURNER J. The cause of the predominantly sinistral occurrence of thrombosis of the pelvic veins. Angiology. 1957 Oct;8(5):419-27. doi: 10.1177/000331975700800505. No abstract available.</citation>
    <PMID>13478912</PMID>
  </reference>
  <reference>
    <citation>Cockett FB, Thomas ML. The iliac compression syndrome. Br J Surg. 1965 Oct;52(10):816-21. doi: 10.1002/bjs.1800521028. No abstract available.</citation>
    <PMID>5828716</PMID>
  </reference>
  <reference>
    <citation>Marston W, Fish D, Unger J, Keagy B. Incidence of and risk factors for iliocaval venous obstruction in patients with active or healed venous leg ulcers. J Vasc Surg. 2011 May;53(5):1303-8. doi: 10.1016/j.jvs.2010.10.120. Epub 2011 Jan 7.</citation>
    <PMID>21215568</PMID>
  </reference>
  <reference>
    <citation>Etufugh CN, Phillips TJ. Venous ulcers. Clin Dermatol. 2007 Jan-Feb;25(1):121-30. doi: 10.1016/j.clindermatol.2006.09.004.</citation>
    <PMID>17276209</PMID>
  </reference>
  <reference>
    <citation>McGuckin M, Waterman R, Brooks J, Cherry G, Porten L, Hurley S, Kerstein MD. Validation of venous leg ulcer guidelines in the United States and United Kingdom. Am J Surg. 2002 Feb;183(2):132-7. doi: 10.1016/s0002-9610(01)00856-x.</citation>
    <PMID>11918875</PMID>
  </reference>
  <reference>
    <citation>Lin EP, Bhatt S, Rubens D, Dogra VS. The importance of monophasic Doppler waveforms in the common femoral vein: a retrospective study. J Ultrasound Med. 2007 Jul;26(7):885-91. doi: 10.7863/jum.2007.26.7.885.</citation>
    <PMID>17592051</PMID>
  </reference>
  <reference>
    <citation>Neglen P, Raju S. Intravascular ultrasound scan evaluation of the obstructed vein. J Vasc Surg. 2002 Apr;35(4):694-700. doi: 10.1067/mva.2002.121127.</citation>
    <PMID>11932665</PMID>
  </reference>
  <reference>
    <citation>Labropoulos N, Borge M, Pierce K, Pappas PJ. Criteria for defining significant central vein stenosis with duplex ultrasound. J Vasc Surg. 2007 Jul;46(1):101-7. doi: 10.1016/j.jvs.2007.02.062. Epub 2007 May 30.</citation>
    <PMID>17540535</PMID>
  </reference>
  <results_reference>
    <citation>Virchow R. Uber die erweiterung kleiner gefasse. Arch Path Anat. 1851; 3:427.</citation>
  </results_reference>
  <results_reference>
    <citation>Malgor RD, Adrahtas D, Spentzouris G, Gasparis AP, Tassiopoulos AK, Labropoulos N. The role of duplex ultrasound in the workup of pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2014 Jan;2(1):34-8. doi: 10.1016/j.jvsv.2013.06.004. Epub 2013 Sep 24.</citation>
    <PMID>26992966</PMID>
  </results_reference>
  <results_reference>
    <citation>Malgor RD, Labropoulos N. Diagnosis of venous disease with duplex ultrasound. Phlebology. 2013 Mar;28 Suppl 1:158-61. doi: 10.1177/0268355513476653.</citation>
    <PMID>23482553</PMID>
  </results_reference>
  <results_reference>
    <citation>Raju S, Hollis K, Neglen P. Obstructive lesions of the inferior vena cava: clinical features and endovenous treatment. J Vasc Surg. 2006 Oct;44(4):820-7. doi: 10.1016/j.jvs.2006.05.054. Epub 2006 Aug 22.</citation>
    <PMID>16926084</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 13, 2014</last_update_submitted>
  <last_update_submitted_qc>September 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Dante Pazzanese de Cardiologia</investigator_affiliation>
    <investigator_full_name>Fabio H Rossi</investigator_full_name>
    <investigator_title>PHD</investigator_title>
  </responsible_party>
  <keyword>Iliac Vein Obstruction</keyword>
  <keyword>May-Thurner Syndrome</keyword>
  <keyword>Cockett Syndrome</keyword>
  <keyword>Vascular Ultrasound</keyword>
  <keyword>IVUS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>May-Thurner Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02240914
org study id: IDPC_ 4 2014
nct id: NCT02240914
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
-  Determine the sensitivity, specificity and accuracy of vascular ultrasound, using direct
           and indirect ultrasonographic signs, in the obstructive diseases of iliac venous
           segment, in patients with advanced chronic venous insufficiency (CEAP 3-6), considering
           the intravascular ultrasound (IVUS) as the gold standard for this diagnosis.

        -  Develop an algorithm for noninvasive ultrasound investigation of obstructive lesions in
           the iliac segment in patients with advanced chronic venous insufficiency (CEAP 3-6).
observational model: Cohort
time perspective: Prospective
measure: A composite of direct and indirect ultrasonographic signs as a measure of iliac vein stenosis
time frame: within 15 days
description: • 50 patients with Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification C3-6 undergoing iliac and common femoral vascular ultrasound imaging with intention to detect significative iliac vein obstructions ( > 50%) and this results will be compared with the gold standard method - IVUS. Primary Endpoints: venous imaging in B- mode, volume flow and expiratory velocity in femoral vein, and the velocity relation before and through the stenosis provided by vascular ultrasound will be analyzed. Venous IVUS will provide measurements of minimum and maximum diameter reduction due to iliofemoral venous obstruction/compression; cross-sectional area reduction will also be measured.
The percentage of significant stenosis detected at various thresholds [ < 50%, 50-80%,> 80%] with each method will be compared in a pair-wise fashion. This will be done with descriptive statistics of the detection rates for each method, and the rate of discordance between the two.
arm group label: Vascular USG and IVUS imaging diagnosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Patrick B Metzger, MD
role: Principal Investigator
affiliation: Vascular Surgeon
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
citation: MAY R, THURNER J. The cause of the predominantly sinistral occurrence of thrombosis of the pelvic veins. Angiology. 1957 Oct;8(5):419-27. doi: 10.1177/000331975700800505. No abstract available.
PMID: 13478912
citation: Cockett FB, Thomas ML. The iliac compression syndrome. Br J Surg. 1965 Oct;52(10):816-21. doi: 10.1002/bjs.1800521028. No abstract available.
PMID: 5828716
citation: Marston W, Fish D, Unger J, Keagy B. Incidence of and risk factors for iliocaval venous obstruction in patients with active or healed venous leg ulcers. J Vasc Surg. 2011 May;53(5):1303-8. doi: 10.1016/j.jvs.2010.10.120. Epub 2011 Jan 7.
PMID: 21215568
citation: Etufugh CN, Phillips TJ. Venous ulcers. Clin Dermatol. 2007 Jan-Feb;25(1):121-30. doi: 10.1016/j.clindermatol.2006.09.004.
PMID: 17276209
citation: McGuckin M, Waterman R, Brooks J, Cherry G, Porten L, Hurley S, Kerstein MD. Validation of venous leg ulcer guidelines in the United States and United Kingdom. Am J Surg. 2002 Feb;183(2):132-7. doi: 10.1016/s0002-9610(01)00856-x.
PMID: 11918875
citation: Lin EP, Bhatt S, Rubens D, Dogra VS. The importance of monophasic Doppler waveforms in the common femoral vein: a retrospective study. J Ultrasound Med. 2007 Jul;26(7):885-91. doi: 10.7863/jum.2007.26.7.885.
PMID: 17592051
citation: Neglen P, Raju S. Intravascular ultrasound scan evaluation of the obstructed vein. J Vasc Surg. 2002 Apr;35(4):694-700. doi: 10.1067/mva.2002.121127.
PMID: 11932665
citation: Labropoulos N, Borge M, Pierce K, Pappas PJ. Criteria for defining significant central vein stenosis with duplex ultrasound. J Vasc Surg. 2007 Jul;46(1):101-7. doi: 10.1016/j.jvs.2007.02.062. Epub 2007 May 30.
PMID: 17540535
citation: Virchow R. Uber die erweiterung kleiner gefasse. Arch Path Anat. 1851; 3:427.
citation: Malgor RD, Adrahtas D, Spentzouris G, Gasparis AP, Tassiopoulos AK, Labropoulos N. The role of duplex ultrasound in the workup of pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2014 Jan;2(1):34-8. doi: 10.1016/j.jvsv.2013.06.004. Epub 2013 Sep 24.
PMID: 26992966
citation: Malgor RD, Labropoulos N. Diagnosis of venous disease with duplex ultrasound. Phlebology. 2013 Mar;28 Suppl 1:158-61. doi: 10.1177/0268355513476653.
PMID: 23482553
citation: Raju S, Hollis K, Neglen P. Obstructive lesions of the inferior vena cava: clinical features and endovenous treatment. J Vasc Surg. 2006 Oct;44(4):820-7. doi: 10.1016/j.jvs.2006.05.054. Epub 2006 Aug 22.
PMID: 16926084
responsible party type: Sponsor-Investigator
investigator affiliation: Instituto Dante Pazzanese de Cardiologia
investigator full name: Fabio H Rossi
investigator title: PHD
mesh term: May-Thurner Syndrome
mesh term: Syndrome