<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/NCT04430478</url>
  </required_header>
  <id_info>
    <org_study_id>323</org_study_id>
    <nct_id>NCT04430478</nct_id>
  </id_info>
  <brief_title>Volume Flow-guided Angioplasty of Dysfunctional Dialysis Access</brief_title>
  <acronym>VOLA</acronym>
  <official_title>VOLume Flow-guided Angioplasty of Dysfunctional Autologous Arteriovenous Fistula. The VOLA Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Attikon Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Attikon Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a pilot study investigating a new concept of intra-procedural percutaneous duplex&#xD;
      ultrasound (DUS) volume flow-guided balloon angioplasty for the quantification and&#xD;
      optimization of endovascular treatment outcomes of dysfunctional autologous arteriovenous&#xD;
      fistulae (AVF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-center, single-arm clinical trial introducing a new functional&#xD;
      index of clinical success of endovascular treatment and investigating the feasibility of&#xD;
      volume flow-guided balloon angioplasty of dysfunctional AVF assessed with intraprocedural&#xD;
      percutaneous DUS. The study will include consecutive patients undergoing&#xD;
      fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF in the&#xD;
      investigator's center. Exclusion criteria will be: (i) not available volume flow values at&#xD;
      the time of AVF maturation, (ii) patients with arteriovenous synthetic grafts. Patients'&#xD;
      demographical data, dialysis access history, and procedural details will be recorded.&#xD;
      Intraprocedural volume flow measurements will be obtained just prior to the procedure and&#xD;
      after each balloon dilation. Volume flow measurements will be correlated with digital&#xD;
      subtraction angiography quantitative vessel analysis (QVA) performed by an independent&#xD;
      investigator blinded to the volume flow analysis outcomes. Follow up DUS imaging including&#xD;
      volume-flow assessment will be set at 24h, 6, and 12 months after the index procedure, while&#xD;
      fistulograms with QVA analysis will be performed at 6 and 12 months. All DUS measurements&#xD;
      will be performed using the same imaging protocol and the same operator. The study's primary&#xD;
      endpoints will be (i) the quantification of angioplasty outcome using sequential DUS volume&#xD;
      flow analysis following each balloon catheter dilation and (ii) to assess the correlation&#xD;
      between volume flow and clinical success defined as high-quality dialysis for a period of at&#xD;
      least one month. Secondary endpoints will be (i) re-intervention-free interval defined as the&#xD;
      time interval between endovascular treatment and reintervention due to dysfunction recurrence&#xD;
      of the treated AVF and (ii) correlation between volume flow and QVA measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2019</start_date>
  <completion_date type="Actual">December 21, 2020</completion_date>
  <primary_completion_date type="Actual">December 21, 2020</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>
    <intervention_model_description>The study will include consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. Intraprocedural volume flow measurements will be obtained just prior to the procedure and after each balloon dilation. Volume flow measurements will be correlated with digital subtraction angiography quantitative vessel analysis (QVA) performed by an independent investigator blinded to the volume flow analysis outcomes. Follow up DUS imaging including volume-flow assessment will be set at 24h, 6, and 12 months, while fistulograms with QVA analysis will be performed at 6 and 12 months.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>QVA analysis will be performed by an investigator blinded to the volume flow analysis outcomes.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Quantification of angioplasty outcome</measure>
    <time_frame>At the end of the procedure</time_frame>
    <description>The quantification of angioplasty outcomes will be performed using sequential DUS volume flow analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duplex Ultrasound volume flow values achieved following angioplasty and clinical success</measure>
    <time_frame>1 month</time_frame>
    <description>The investigators will use ROC analysis to define a cut off value of volume flow increase (ml per minute) at the end of the procedure to predict clinical success.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Re-intervention-free interval</measure>
    <time_frame>6 months</time_frame>
    <description>The time interval between endovascular treatment and reintervention due to dysfunction recurrence of the treated AVF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Duplex Ultrasound volume flow values with digital subtraction angiography QVA measurements.</measure>
    <time_frame>6 months</time_frame>
    <description>To assess wheather a significant volume flow decrease of &gt;50% measured by Duplex ultrasound indicates an analougously significant late lumen loss (mm) of the target lesion measured with QVA analysis of digital subtracted venography</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Dialysis Access Malfunction</condition>
  <arm_group>
    <arm_group_label>Volume flow group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consecutive patients undergoing sequential volume flow measurements using percutaneous DUS</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Volume flow guided angioplasty</intervention_name>
    <description>Volume flow measurements using DUS will be obtained at the end of each balloon dilation, at 24 hours, 6 months, and one year after index procedure.</description>
    <arm_group_label>Volume flow group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients undergoing fluoroscopically-guided percutaneous balloon&#xD;
             angioplasty due to dysfunctional AVF&#xD;
&#xD;
          -  Signed consent form&#xD;
&#xD;
          -  Agree to the imaging protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not available volume flow values at the time of AVF maturation&#xD;
&#xD;
          -  patients with arteriovenous synthetic grafts.&#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>Stavros Spiliopoulos, MD, PhD, EBIR</last_name>
    <role>Principal Investigator</role>
    <affiliation>ATTIKO University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>&quot;Attikon&quot; University General Hospital</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>12461</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medifil SA Hemodialysis Centre</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nefrologiki SA Hemodialysis Centre</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>December 21, 2020</last_update_submitted>
  <last_update_submitted_qc>December 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Attikon Hospital</investigator_affiliation>
    <investigator_full_name>Stavros Spiliopoulos</investigator_full_name>
    <investigator_title>Assistant Professor in Interventional Radiology</investigator_title>
  </responsible_party>
  <keyword>Percutaneous transluminal angioplasty</keyword>
  <keyword>Volume-flow measurment</keyword>
  <keyword>Autologous arteriovenous fistula</keyword>
  <keyword>Dialysis access</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arteriovenous Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The investigators plan to make individual participant data (IPD) available to other researchers upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After the publication of the study, indefinitely</ipd_time_frame>
    <ipd_access_criteria>Other researchers upon request</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04430478
org study id: 323
nct id: NCT04430478
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a pilot study investigating a new concept of intra-procedural percutaneous duplex
      ultrasound (DUS) volume flow-guided balloon angioplasty for the quantification and
      optimization of endovascular treatment outcomes of dysfunctional autologous arteriovenous
      fistulae (AVF).
This is a prospective, single-center, single-arm clinical trial introducing a new functional
      index of clinical success of endovascular treatment and investigating the feasibility of
      volume flow-guided balloon angioplasty of dysfunctional AVF assessed with intraprocedural
      percutaneous DUS. The study will include consecutive patients undergoing
      fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF in the
      investigator's center. Exclusion criteria will be: (i) not available volume flow values at
      the time of AVF maturation, (ii) patients with arteriovenous synthetic grafts. Patients'
      demographical data, dialysis access history, and procedural details will be recorded.
      Intraprocedural volume flow measurements will be obtained just prior to the procedure and
      after each balloon dilation. Volume flow measurements will be correlated with digital
      subtraction angiography quantitative vessel analysis (QVA) performed by an independent
      investigator blinded to the volume flow analysis outcomes. Follow up DUS imaging including
      volume-flow assessment will be set at 24h, 6, and 12 months after the index procedure, while
      fistulograms with QVA analysis will be performed at 6 and 12 months. All DUS measurements
      will be performed using the same imaging protocol and the same operator. The study's primary
      endpoints will be (i) the quantification of angioplasty outcome using sequential DUS volume
      flow analysis following each balloon catheter dilation and (ii) to assess the correlation
      between volume flow and clinical success defined as high-quality dialysis for a period of at
      least one month. Secondary endpoints will be (i) re-intervention-free interval defined as the
      time interval between endovascular treatment and reintervention due to dysfunction recurrence
      of the treated AVF and (ii) correlation between volume flow and QVA measurements.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The study will include consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. Intraprocedural volume flow measurements will be obtained just prior to the procedure and after each balloon dilation. Volume flow measurements will be correlated with digital subtraction angiography quantitative vessel analysis (QVA) performed by an independent investigator blinded to the volume flow analysis outcomes. Follow up DUS imaging including volume-flow assessment will be set at 24h, 6, and 12 months, while fistulograms with QVA analysis will be performed at 6 and 12 months.
primary purpose: Diagnostic
masking: None (Open Label)
masking description: QVA analysis will be performed by an investigator blinded to the volume flow analysis outcomes.
measure: Quantification of angioplasty outcome
time frame: At the end of the procedure
description: The quantification of angioplasty outcomes will be performed using sequential DUS volume flow analysis
measure: Duplex Ultrasound volume flow values achieved following angioplasty and clinical success
time frame: 1 month
description: The investigators will use ROC analysis to define a cut off value of volume flow increase (ml per minute) at the end of the procedure to predict clinical success.
measure: Re-intervention-free interval
time frame: 6 months
description: The time interval between endovascular treatment and reintervention due to dysfunction recurrence of the treated AVF
measure: Comparison of Duplex Ultrasound volume flow values with digital subtraction angiography QVA measurements.
time frame: 6 months
description: To assess wheather a significant volume flow decrease of >50% measured by Duplex ultrasound indicates an analougously significant late lumen loss (mm) of the target lesion measured with QVA analysis of digital subtracted venography
arm group label: Volume flow group
arm group type: Experimental
description: Consecutive patients undergoing sequential volume flow measurements using percutaneous DUS
intervention type: Diagnostic Test
intervention name: Volume flow guided angioplasty
description: Volume flow measurements using DUS will be obtained at the end of each balloon dilation, at 24 hours, 6 months, and one year after index procedure.
arm group label: Volume flow group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stavros Spiliopoulos, MD, PhD, EBIR
role: Principal Investigator
affiliation: ATTIKO University Hospital
facility: 
facility: 
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Attikon Hospital
investigator full name: Stavros Spiliopoulos
investigator title: Assistant Professor in Interventional Radiology
mesh term: Arteriovenous Fistula
sharing ipd: Yes
ipd description: The investigators plan to make individual participant data (IPD) available to other researchers upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After the publication of the study, indefinitely
ipd access criteria: Other researchers upon request