<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/NCT03035747</url>
  </required_header>
  <id_info>
    <org_study_id>A001</org_study_id>
    <nct_id>NCT03035747</nct_id>
  </id_info>
  <brief_title>Ongoing Registry of Treatment of Chronic Venous Diseases</brief_title>
  <acronym>RRT CVD</acronym>
  <official_title>Russian Registry of Treatment of Chronic Venous Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medalp Private Surgery Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pirogov Russian National Research Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medalp Private Surgery Clinic</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>
      Ongoing registration of patients with varicose veins disease treated by means of conventional&#xD;
      surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data of patients treated in different Russian medical centers are entered in a prospective&#xD;
      digital database, and continuously updated.&#xD;
&#xD;
      There is planned to conduct prospective randomized, cohort and observational studies on the&#xD;
      site of register&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Anticipated">July 2036</completion_date>
  <primary_completion_date type="Anticipated">July 2036</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Change in patency target veins assessed by duplex ultrasonography in different follow up periods after conventional surgery, endovenous thermal ablations, sclerotherapy or non-tumescent non-thermal methods</measure>
    <time_frame>Baseline, 3 - 6, 12 months post-intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey (optional)</measure>
    <time_frame>Baseline, 3 and 12 months post-intervention</time_frame>
    <description>The SF-36 is a generic QoL questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Venous Clinical Severity Score (VCSS) (optional)</measure>
    <time_frame>Baseline, 3 and 12 months post-intervention</time_frame>
    <description>The VCSS is a validated scoring system for assessing signs, symptoms and complaints of venous disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life (QoL), assessed by Aberdeen Varicose Vein Questionnaire (AVVQ) (optional)</measure>
    <time_frame>Baseline, 3 and 12 months post-intervention</time_frame>
    <description>The AVVQ is a disease-specific QoL questionnaire aimed at venous disease.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Varicose Veins of Lower Limb</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conventional surgery</intervention_name>
    <description>high ligation and stripping of incompetent saphenous veins</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endovenous laser ablation</intervention_name>
    <description>endovenous laser ablation of incompetent saphenous veins</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sclerotherapy</intervention_name>
    <description>ultrasound guided or catheter or or any other methods sclerotherapy of incompetent saphenous or varicose veins</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endovenous radiofrequency ablation</intervention_name>
    <description>endovenous radiofrequency ablation of incompetent saphenous veins</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>phlebectomy</intervention_name>
    <description>hooks phlebectomy of varicose veins</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing interventions in cases varicose vein disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Varicose veins with any source of pathological reflux, C2 - C6 according to the CEAP&#xD;
             classification&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no exclusion criteria&#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>Evgeny Ilyukhin, MD, PhD</last_name>
    <phone>+79218451722</phone>
    <email>evgeny@ilyukhin.info</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medalp private surgery clinic</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oleg Shonov, MD</last_name>
      <email>shonov.o@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>http://www.venousregistry.org/</url>
    <description>Russian Register of Treatment of Chronic Venous Diseases (RRT CVD)</description>
  </link>
  <link>
    <url>https://phlebounion.ru/en/</url>
    <description>Russian Phlebological Association (RPA)</description>
  </link>
  <link>
    <url>https://www.uip-phlebology.org/society?code=EU</url>
    <description>Confirmation page about membership of RPA in the International Union of Phlebology</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medalp Private Surgery Clinic</investigator_affiliation>
    <investigator_full_name>Evgeny Ilyukhin</investigator_full_name>
    <investigator_title>Сhief surgeon Medalp Private Surgery Clinic</investigator_title>
  </responsible_party>
  <keyword>registry</keyword>
  <keyword>varicose veins</keyword>
  <keyword>conventional surgery</keyword>
  <keyword>thermal ablation</keyword>
  <keyword>radiofrequency</keyword>
  <keyword>laser</keyword>
  <keyword>sclerotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Veins</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/NCT03035747
org study id: A001
nct id: NCT03035747
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Ongoing registration of patients with varicose veins disease treated by means of conventional
      surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods
Data of patients treated in different Russian medical centers are entered in a prospective
      digital database, and continuously updated.

      There is planned to conduct prospective randomized, cohort and observational studies on the
      site of register
observational model: Other
time perspective: Prospective
measure: Change in patency target veins assessed by duplex ultrasonography in different follow up periods after conventional surgery, endovenous thermal ablations, sclerotherapy or non-tumescent non-thermal methods
time frame: Baseline, 3 - 6, 12 months post-intervention
measure: Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey (optional)
time frame: Baseline, 3 and 12 months post-intervention
description: The SF-36 is a generic QoL questionnaire.
measure: Change in Venous Clinical Severity Score (VCSS) (optional)
time frame: Baseline, 3 and 12 months post-intervention
description: The VCSS is a validated scoring system for assessing signs, symptoms and complaints of venous disease.
measure: Change in Quality of Life (QoL), assessed by Aberdeen Varicose Vein Questionnaire (AVVQ) (optional)
time frame: Baseline, 3 and 12 months post-intervention
description: The AVVQ is a disease-specific QoL questionnaire aimed at venous disease.
intervention type: Procedure
intervention name: conventional surgery
description: high ligation and stripping of incompetent saphenous veins
intervention type: Procedure
intervention name: endovenous laser ablation
description: endovenous laser ablation of incompetent saphenous veins
intervention type: Procedure
intervention name: sclerotherapy
description: ultrasound guided or catheter or or any other methods sclerotherapy of incompetent saphenous or varicose veins
intervention type: Procedure
intervention name: endovenous radiofrequency ablation
description: endovenous radiofrequency ablation of incompetent saphenous veins
intervention type: Procedure
intervention name: phlebectomy
description: hooks phlebectomy of varicose veins
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evgeny Ilyukhin, MD, PhD
phone: +79218451722
email: evgeny@ilyukhin.info
facility: 
status: Recruiting
contact: 
country: Russian Federation
url: http://www.venousregistry.org/
description: Russian Register of Treatment of Chronic Venous Diseases (RRT CVD)
url: https://phlebounion.ru/en/
description: Russian Phlebological Association (RPA)
url: https://www.uip-phlebology.org/society?code=EU
description: Confirmation page about membership of RPA in the International Union of Phlebology
responsible party type: Principal Investigator
investigator affiliation: Medalp Private Surgery Clinic
investigator full name: Evgeny Ilyukhin
investigator title: Сhief surgeon Medalp Private Surgery Clinic
mesh term: Varicose Veins