<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/NCT04399941</url>
  </required_header>
  <id_info>
    <org_study_id>H-37396</org_study_id>
    <secondary_id>1R21DK119740-01A1</secondary_id>
    <nct_id>NCT04399941</nct_id>
  </id_info>
  <brief_title>Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis</brief_title>
  <acronym>IVUS in ESRD</acronym>
  <official_title>Role of Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hemodialysis represents a life line of patients with end stage renal disease, who are&#xD;
      commonly maintained on hemodialysis through catheters. Prolonged exposure to these catheters&#xD;
      eventually damages the walls of veins, which results in stenosis at the local site. This&#xD;
      condition is called central venous stenosis (CVS) and affects number of patients on&#xD;
      hemodialysis in the United States and can compromise the dialysis efficacy. The current&#xD;
      diagnostic modality for CVS is venography, which has several limitations. This study proposes&#xD;
      to examine intravenous ultrasound (IVUS) as a potentially superior modality, which will&#xD;
      provide additional information.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 3, 2021</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2024</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Extent of stenosis</measure>
    <time_frame>18 months</time_frame>
    <description>The severity of venous stenosis will be assessed using venogram and IVUS results. It will be calculated as the percentage diameter or area reduction, expressed as the ratio of the MLD or MLA to the RVD or RVA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of lesions</measure>
    <time_frame>18 months</time_frame>
    <description>The length of each lesion will be measured between points with &gt;50% diameter reduction in comparison to the referenced vein diameter and the referenced vein area at the pre-stenotic venous segment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morphology of lesion</measure>
    <time_frame>18 months</time_frame>
    <description>The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>IVUS and venography group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Venography</intervention_name>
    <description>The venography will be performed as part of the patient's standard of care. The dialysis access will be punctured upstream of the arteriovenous anastomosis in AVF or AVG using a 4-F coaxial access set (Micro- puncture; Cook, Inc, Bloomington, Indiana). The contrast will be injected intravenously by a pump with 200 psi and a bolus of 2m/sec for total of 5 ml during upper extremity vein filming and 10 ml of contrast bolus by 3 ml/s during central vein filming while holding the breath in inspiration in anterioposterior plane.</description>
    <arm_group_label>IVUS and venography group</arm_group_label>
    <other_name>Fistulogram</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Intravascular ultrasound (IVUS)</intervention_name>
    <description>IVUS will be performed through the same sheath of the coaxial access set using an Eagle Eye Platinum RX digital catheter 7F over a compatible guidewire under fluoroscopic guidance. The lesion will be estimated fluoroscopically from the marker IVUS catheter in the vein and the cranial and caudal margins of stenotic lesion will be directly visualized during pullback of the IVUS catheter.</description>
    <arm_group_label>IVUS and venography group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Image processing</intervention_name>
    <description>Image processing will be performed by two radiologists in a blinded manner on the images devoid of personal identifier. An adjudication committee will oversee the process and confirm their findings in case of a discrepancy.</description>
    <arm_group_label>IVUS and venography group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ESRD (end stage renal disease) patients at BMC (Boston Medical Center)&#xD;
&#xD;
          -  Receiving hemodialysis&#xD;
&#xD;
          -  Has a dialysis access malfunction&#xD;
&#xD;
          -  Undergoing a diagnostic fistulogram for the dialysis access malfunction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vipul Chitalia, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vipul Chitalia, MD PhD</last_name>
    <phone>617 638 7330</phone>
    <email>vipul.chitalia@bmc.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vipul Chitalia, MD PhD</last_name>
      <email>vipul.chitalia@bmc.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>July 30, 2023</last_update_submitted>
  <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intravenous ultrasound (IVUS)</keyword>
  <keyword>central venous stenosis (CVS)</keyword>
  <keyword>hemodialysis</keyword>
  <keyword>dialysis access malfunction</keyword>
  <keyword>fistulogram</keyword>
  <keyword>stenosis</keyword>
  <keyword>virtual histology (VH-IVUS) software</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04399941
org study id: H-37396
secondary id: 1R21DK119740-01A1
nct id: NCT04399941
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Hemodialysis represents a life line of patients with end stage renal disease, who are
      commonly maintained on hemodialysis through catheters. Prolonged exposure to these catheters
      eventually damages the walls of veins, which results in stenosis at the local site. This
      condition is called central venous stenosis (CVS) and affects number of patients on
      hemodialysis in the United States and can compromise the dialysis efficacy. The current
      diagnostic modality for CVS is venography, which has several limitations. This study proposes
      to examine intravenous ultrasound (IVUS) as a potentially superior modality, which will
      provide additional information.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Extent of stenosis
time frame: 18 months
description: The severity of venous stenosis will be assessed using venogram and IVUS results. It will be calculated as the percentage diameter or area reduction, expressed as the ratio of the MLD or MLA to the RVD or RVA.
measure: Length of lesions
time frame: 18 months
description: The length of each lesion will be measured between points with >50% diameter reduction in comparison to the referenced vein diameter and the referenced vein area at the pre-stenotic venous segment.
measure: Morphology of lesion
time frame: 18 months
description: The morphology of lesion will be defined as fibrotic and fibrofatty based on IVUS images.
arm group label: IVUS and venography group
arm group type: Experimental
description: Participants in the this group will receive venography/fistulogram, intravascular ultrasound (IVUS), and image processing.
intervention type: Diagnostic Test
intervention name: Venography
description: The venography will be performed as part of the patient's standard of care. The dialysis access will be punctured upstream of the arteriovenous anastomosis in AVF or AVG using a 4-F coaxial access set (Micro- puncture; Cook, Inc, Bloomington, Indiana). The contrast will be injected intravenously by a pump with 200 psi and a bolus of 2m/sec for total of 5 ml during upper extremity vein filming and 10 ml of contrast bolus by 3 ml/s during central vein filming while holding the breath in inspiration in anterioposterior plane.
arm group label: IVUS and venography group
other name: Fistulogram
intervention type: Diagnostic Test
intervention name: Intravascular ultrasound (IVUS)
description: IVUS will be performed through the same sheath of the coaxial access set using an Eagle Eye Platinum RX digital catheter 7F over a compatible guidewire under fluoroscopic guidance. The lesion will be estimated fluoroscopically from the marker IVUS catheter in the vein and the cranial and caudal margins of stenotic lesion will be directly visualized during pullback of the IVUS catheter.
arm group label: IVUS and venography group
intervention type: Other
intervention name: Image processing
description: Image processing will be performed by two radiologists in a blinded manner on the images devoid of personal identifier. An adjudication committee will oversee the process and confirm their findings in case of a discrepancy.
arm group label: IVUS and venography group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Vipul Chitalia, MD PhD
role: Principal Investigator
affiliation: Boston Medical Center
last name: Vipul Chitalia, MD PhD
phone: 617 638 7330
email: vipul.chitalia@bmc.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
sharing ipd: No