<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/NCT04404985</url>
  </required_header>
  <id_info>
    <org_study_id>F0002</org_study_id>
    <nct_id>NCT04404985</nct_id>
  </id_info>
  <brief_title>Endovascular vs Surgical Arteriovenous Fistula Outcomes</brief_title>
  <acronym>ESAVFO</acronym>
  <official_title>Endovascular vs Surgical Arteriovenous Fistula Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</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>
      Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but&#xD;
      many of them fail to mature. There are two techniques of creating AVFs either the traditional&#xD;
      way with surgery( Surgical AVFs) or novel per-cutaneous technique Endo- AVFs.&#xD;
&#xD;
      Investigators will pilot an randomized clinical trial of endo-AVFs and surgical AVFs at&#xD;
      University of Alabama at Birmingham to determine the feasibility of patient recruitment,&#xD;
      randomization, and retention. This pilot study will set the stage for a full-scale randomized&#xD;
      clinical trial in future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but&#xD;
      many of them fail to mature. Despite concerted efforts to improve surgical AVF outcomes&#xD;
      during the past 20 years, many new AVFs fail to mature, even after interventions to salvage&#xD;
      them (assisted maturation). Postoperative ultrasounds of immature AVFs frequently demonstrate&#xD;
      decreased flow with narrowing at the anastomosis . Surgically created AVFs typically have a&#xD;
      90o angle at the anastomosis, yet computational fluid dynamics suggest that an anastomotic&#xD;
      angle &lt;30o improves the flow hemodynamics. Therefore, there has been great interest in novel&#xD;
      AVF technologies to limit vascular injury and improve flow dynamics and maturation rates. The&#xD;
      new technology evaluated herein (endovascular AVF (endo-AVF) has the potential to achieve&#xD;
      these goals and reduce the cost of vascular access care.&#xD;
&#xD;
      Endo-AVF, a novel per-cutaneous technique of AVF creation, was approved by the FDA in 2018,&#xD;
      and has been used in U.S. hemodialysis patients . In contrast to the surgical technique (the&#xD;
      current standard), this non-surgical approach (1) minimizes vascular injury at the time of&#xD;
      AVF creation and (2) creates a channel between the artery and vein with an angle approaching&#xD;
      0o. These two features provide a scientific rationale for superior maturation compared with&#xD;
      that of surgical AVF Investigators will perform a single-center, prospective pilot randomized&#xD;
      clinical trial. Investigators will recruit 80 patients who have advanced chronic kidney&#xD;
      disease or on hemodialysis with a catheter ,who there pre- operative Ultrasound showed they&#xD;
      are eligible to surgical or endo-vascular AVF. Participants will be randomized to one of two&#xD;
      groups: an surgical AVF intervention group that will undergo a routine surgical fistula&#xD;
      creation, or an endo-vascular AVF intervention group will undergo per-cutaneous fistula&#xD;
      creation . Participants will be followed for 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2022</start_date>
  <completion_date type="Anticipated">September 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physiological fistula maturity</measure>
    <time_frame>0-6 weeks</time_frame>
    <description>Assess by ultrasound . To assess blood flow within the fistula.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physiological fistula maturity</measure>
    <time_frame>0-6 weeks</time_frame>
    <description>Assess by ultrasound . To assess diameter of the fistula</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical fistula maturity</measure>
    <time_frame>6 weeks-6 months</time_frame>
    <description>Assess by ultrasound. Able to use the fistula for dialysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fistula survival</measure>
    <time_frame>0-2 years</time_frame>
    <description>Assess by ultrasound. Continue to able to use fistula for dialysis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Dialysis Fistula Creation</condition>
  <condition>Endo-vascular AVFs</condition>
  <arm_group>
    <arm_group_label>Surgical AVFs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants who initiated dialysis with a catheter or have advanced chronic kidney disease ,these patients who an Surgical AVF intervention group that will undergo a routine surgical AVF creation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endo-vascular AVF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who initiated dialysis with a catheter or have advanced chronic kidney disease ,these patients who an endo-vascular AVF intervention group that will undergo a per-cutaneous AVF creation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical AVF</intervention_name>
    <description>Surgical fistula creation is standard surgical procedures, where a small cut through the skin is made to create a channel directly between a vein and artery .&#xD;
The study procedures are standard clinical practice, and not considered an experimental procedure.</description>
    <arm_group_label>Surgical AVFs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endo-vascular AVF</intervention_name>
    <description>Endovascular fistula creation is a minimally invasive procedure used to create a canal between close artery and vein at the forearm. A magnet attached to a catheter is passed over a guidewire into the artery while another magnet passed over the guidewire into the vein. The two magnets are aligned close to each other, then the radiofrequency electrode is released from the venous catheter and energized for 2 seconds, creating a channel between the vein and the artery.</description>
    <arm_group_label>Endo-vascular AVF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Study will include participants who are 18 years and older who are scheduled to have&#xD;
             an AVF&#xD;
&#xD;
          -  preoperative ultrasound showed feasibility to have an endo-vascular AVF vs surgical&#xD;
             upper arm AVF&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 18 years&#xD;
&#xD;
          -  participants eligible for low forearm AVF ( radio-cephalic)&#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>UAB</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alian Al-Balas, MD</last_name>
      <phone>205-975-9676</phone>
      <email>aalbalas@uabmc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Michael Allon, MD</last_name>
      <phone>(205) 975-9676</phone>
      <email>mallon@uabmc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>June 7, 2023</last_update_submitted>
  <last_update_submitted_qc>June 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Alian Al-Balas</investigator_full_name>
    <investigator_title>Associate Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arteriovenous Fistula</mesh_term>
    <mesh_term>Fistula</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/NCT04404985
org study id: F0002
nct id: NCT04404985
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but
      many of them fail to mature. There are two techniques of creating AVFs either the traditional
      way with surgery( Surgical AVFs) or novel per-cutaneous technique Endo- AVFs.

      Investigators will pilot an randomized clinical trial of endo-AVFs and surgical AVFs at
      University of Alabama at Birmingham to determine the feasibility of patient recruitment,
      randomization, and retention. This pilot study will set the stage for a full-scale randomized
      clinical trial in future.
Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but
      many of them fail to mature. Despite concerted efforts to improve surgical AVF outcomes
      during the past 20 years, many new AVFs fail to mature, even after interventions to salvage
      them (assisted maturation). Postoperative ultrasounds of immature AVFs frequently demonstrate
      decreased flow with narrowing at the anastomosis . Surgically created AVFs typically have a
      90o angle at the anastomosis, yet computational fluid dynamics suggest that an anastomotic
      angle <30o improves the flow hemodynamics. Therefore, there has been great interest in novel
      AVF technologies to limit vascular injury and improve flow dynamics and maturation rates. The
      new technology evaluated herein (endovascular AVF (endo-AVF) has the potential to achieve
      these goals and reduce the cost of vascular access care.

      Endo-AVF, a novel per-cutaneous technique of AVF creation, was approved by the FDA in 2018,
      and has been used in U.S. hemodialysis patients . In contrast to the surgical technique (the
      current standard), this non-surgical approach (1) minimizes vascular injury at the time of
      AVF creation and (2) creates a channel between the artery and vein with an angle approaching
      0o. These two features provide a scientific rationale for superior maturation compared with
      that of surgical AVF Investigators will perform a single-center, prospective pilot randomized
      clinical trial. Investigators will recruit 80 patients who have advanced chronic kidney
      disease or on hemodialysis with a catheter ,who there pre- operative Ultrasound showed they
      are eligible to surgical or endo-vascular AVF. Participants will be randomized to one of two
      groups: an surgical AVF intervention group that will undergo a routine surgical fistula
      creation, or an endo-vascular AVF intervention group will undergo per-cutaneous fistula
      creation . Participants will be followed for 2 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Physiological fistula maturity
time frame: 0-6 weeks
description: Assess by ultrasound . To assess blood flow within the fistula.
measure: Physiological fistula maturity
time frame: 0-6 weeks
description: Assess by ultrasound . To assess diameter of the fistula
measure: Clinical fistula maturity
time frame: 6 weeks-6 months
description: Assess by ultrasound. Able to use the fistula for dialysis
measure: Fistula survival
time frame: 0-2 years
description: Assess by ultrasound. Continue to able to use fistula for dialysis
arm group label: Surgical AVFs
arm group type: Active Comparator
description: Participants who initiated dialysis with a catheter or have advanced chronic kidney disease ,these patients who an Surgical AVF intervention group that will undergo a routine surgical AVF creation.
arm group label: Endo-vascular AVF
arm group type: Experimental
description: Participants who initiated dialysis with a catheter or have advanced chronic kidney disease ,these patients who an endo-vascular AVF intervention group that will undergo a per-cutaneous AVF creation.
intervention type: Procedure
intervention name: Surgical AVF
description: Surgical fistula creation is standard surgical procedures, where a small cut through the skin is made to create a channel directly between a vein and artery .
The study procedures are standard clinical practice, and not considered an experimental procedure.
arm group label: Surgical AVFs
intervention type: Procedure
intervention name: Endo-vascular AVF
description: Endovascular fistula creation is a minimally invasive procedure used to create a canal between close artery and vein at the forearm. A magnet attached to a catheter is passed over a guidewire into the artery while another magnet passed over the guidewire into the vein. The two magnets are aligned close to each other, then the radiofrequency electrode is released from the venous catheter and energized for 2 seconds, creating a channel between the vein and the artery.
arm group label: Endo-vascular AVF
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Alian Al-Balas
investigator title: Associate Clinical Professor
mesh term: Arteriovenous Fistula
mesh term: Fistula
sharing ipd: No