<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/NCT03245944</url>
  </required_header>
  <id_info>
    <org_study_id>F0001</org_study_id>
    <nct_id>NCT03245944</nct_id>
  </id_info>
  <brief_title>Optimal Timing of Percutaneous Intervention in Non-maturing Dialysis Fistulas</brief_title>
  <official_title>Optimal Timing of Percutaneous Intervention in Non-maturing Dialysis Fistulas</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. The optimal timing of intervention to salvage immature AVFs is&#xD;
      unknown.The study proposes a randomized clinical trial comparing the clinical and economic&#xD;
      impact of early vs late angioplasty in non-maturing AVFs.&#xD;
&#xD;
      The study proposes a RCT to test the hypothesis that, as compared to early angioplasty of&#xD;
      non-maturing AVFs, late angioplasty results in a lower proportion of AVFs being used at 6&#xD;
      months, but a greater long-term AVF patency , lower requirement of subsequent interventions&#xD;
      to maintain AVF patency for dialysis, and lower overall cost of access maintenance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The optimal timing of intervention in non-maturing AVFs remains controversial, and can only&#xD;
      be definitively addressed by a randomized clinical trial (RCT) comparing early (6 weeks) vs&#xD;
      late (3 months) angioplasty of non-maturing AVFs. The investigators will perform a&#xD;
      single-center, prospective RCT. The investigators will recruit 112 patients who initiated&#xD;
      hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a&#xD;
      6-week postoperative ultrasound that revealed an immature AVF (diameter &lt; 4 mm diameter or&#xD;
      blood flow &lt; 500 ml/min). These patients will be randomized to one of two groups: an early&#xD;
      intervention group that will undergo a routine PTA at 6 weeks after AVF creation, or a late&#xD;
      intervention group in which early PTA will be avoided and subsequently be performed only if&#xD;
      the 3-month ultrasound indicates persistent AVF immaturity. These patients will be followed&#xD;
      for 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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>Fistula Maturity</measure>
    <time_frame>baseline- 6 months</time_frame>
    <description>Ultrasound of the fistula:&#xD;
Mature fistula Criteria:&#xD;
Blood flow of at least 500 ml/min and&#xD;
Minimum diameter of 4 mm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fistula survival</measure>
    <time_frame>baseline-2 years</time_frame>
    <description>Ultrasound of the fistula:&#xD;
Blood flow of at least 500 ml/min and&#xD;
Minimum diameter of 4 mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fistula adequacy</measure>
    <time_frame>Baseline- 2 years</time_frame>
    <description>Fistula is used for hemodilaysis and provide adequate clearance which is measured by:&#xD;
Kt/V: 1.4 where K: clearance [m3/s], t: time [m3/s], V:volume of distribution [m3]</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Immature Arteriovenous Fistula</condition>
  <arm_group>
    <arm_group_label>early angioplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who initiated hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a 6-week postoperative ultrasound that revealed an immature AVF (diameter &lt; 4 mm diameter or blood flow &lt; 500 ml/min). These patients who an early angioplasty intervention group that will undergo a routine Angioplasty at 6 weeks after AVF creation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>late Angioplasty</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who initiated hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a 6-week postoperative ultrasound that revealed an immature AVF (diameter &lt; 4 mm diameter or blood flow &lt; 500 ml/min). These patients who a late angioplasty intervention group in which early Angioplasty will be avoided and subsequently be performed only if the 3-month ultrasound indicates persistent AVF immaturity</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>early Angioplasty</intervention_name>
    <description>Angioplasty is a minimally invasive, endovascular procedure to widen narrowed or obstructed arteries or veins. A deflated balloon attached to a catheter (a balloon catheter) is passed over a guide-wire into the narrowed vessel and then inflated to a fixed size. The balloon forces expansion of the blood vessel and the surrounding muscular wall, allowing an improved blood flow. This is part of standard of care for immature arteriovenous fistulas. Early means pt will get the procedure at 6 weeks from time of initiation of AVFs</description>
    <arm_group_label>early angioplasty</arm_group_label>
    <other_name>Early PTA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>late Angioplasty</intervention_name>
    <description>Angioplasty is a minimally invasive, endovascular procedure to widen narrowed or obstructed arteries or veins. A deflated balloon attached to a catheter (a balloon catheter) is passed over a guide-wire into the narrowed vessel and then inflated to a fixed size. The balloon forces expansion of the blood vessel and the surrounding muscular wall, allowing an improved blood flow. This is part of standard of care for immature arteriovenous fistulas. Late means the angioplasty is done at 3 months from time of AVF creation if still immature at that time.</description>
    <arm_group_label>late Angioplasty</arm_group_label>
    <other_name>Late PTA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with End stage renal disease (ESRD).&#xD;
&#xD;
          -  Patients on hemodialysis.&#xD;
&#xD;
          -  Patients using central venous catheter (CVC).&#xD;
&#xD;
          -  Patients who had a new AVF created after commencing dialysis.&#xD;
&#xD;
          -  Patients who had immature fistula ( 6-week postoperative ultrasound that revealed an&#xD;
             immature AVF (diameter &lt; 4 mm diameter or blood flow &lt; 500 ml/min).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Children with Age below 18&#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>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Al-Balas A, Lee T, Young CJ, Barker-Finkel J, Allon M. Predictors of Initiation for Predialysis Arteriovenous Fistula. Clin J Am Soc Nephrol. 2016 Oct 7;11(10):1802-1808. doi: 10.2215/CJN.00700116. Epub 2016 Sep 14.</citation>
    <PMID>27630181</PMID>
  </reference>
  <reference>
    <citation>Al-Balas A, Lee T, Young CJ, Kepes JA, Barker-Finkel J, Allon M. The Clinical and Economic Effect of Vascular Access Selection in Patients Initiating Hemodialysis with a Catheter. J Am Soc Nephrol. 2017 Dec;28(12):3679-3687. doi: 10.1681/ASN.2016060707. Epub 2017 Jul 14.</citation>
    <PMID>28710090</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>April 24, 2020</last_update_submitted>
  <last_update_submitted_qc>April 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2020</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>Prinicipal investigator</investigator_title>
  </responsible_party>
  <keyword>immature AVF</keyword>
  <keyword>percutaneous intervention</keyword>
  <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>
  <!-- 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/NCT03245944
org study id: F0001
nct id: NCT03245944
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. The optimal timing of intervention to salvage immature AVFs is
      unknown.The study proposes a randomized clinical trial comparing the clinical and economic
      impact of early vs late angioplasty in non-maturing AVFs.

      The study proposes a RCT to test the hypothesis that, as compared to early angioplasty of
      non-maturing AVFs, late angioplasty results in a lower proportion of AVFs being used at 6
      months, but a greater long-term AVF patency , lower requirement of subsequent interventions
      to maintain AVF patency for dialysis, and lower overall cost of access maintenance.
The optimal timing of intervention in non-maturing AVFs remains controversial, and can only
      be definitively addressed by a randomized clinical trial (RCT) comparing early (6 weeks) vs
      late (3 months) angioplasty of non-maturing AVFs. The investigators will perform a
      single-center, prospective RCT. The investigators will recruit 112 patients who initiated
      hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a
      6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or
      blood flow < 500 ml/min). These patients will be randomized to one of two groups: an early
      intervention group that will undergo a routine PTA at 6 weeks after AVF creation, or a late
      intervention group in which early PTA will be avoided and subsequently be performed only if
      the 3-month ultrasound indicates persistent AVF immaturity. These patients will be followed
      for 2 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fistula Maturity
time frame: baseline- 6 months
description: Ultrasound of the fistula:
Mature fistula Criteria:
Blood flow of at least 500 ml/min and
Minimum diameter of 4 mm
measure: Fistula survival
time frame: baseline-2 years
description: Ultrasound of the fistula:
Blood flow of at least 500 ml/min and
Minimum diameter of 4 mm
measure: Fistula adequacy
time frame: Baseline- 2 years
description: Fistula is used for hemodilaysis and provide adequate clearance which is measured by:
Kt/V: 1.4 where K: clearance [m3/s], t: time [m3/s], V:volume of distribution [m3]
arm group label: early angioplasty
arm group type: Active Comparator
description: Patients who initiated hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min). These patients who an early angioplasty intervention group that will undergo a routine Angioplasty at 6 weeks after AVF creation
arm group label: late Angioplasty
arm group type: Experimental
description: Patients who initiated hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min). These patients who a late angioplasty intervention group in which early Angioplasty will be avoided and subsequently be performed only if the 3-month ultrasound indicates persistent AVF immaturity
intervention type: Procedure
intervention name: early Angioplasty
description: Angioplasty is a minimally invasive, endovascular procedure to widen narrowed or obstructed arteries or veins. A deflated balloon attached to a catheter (a balloon catheter) is passed over a guide-wire into the narrowed vessel and then inflated to a fixed size. The balloon forces expansion of the blood vessel and the surrounding muscular wall, allowing an improved blood flow. This is part of standard of care for immature arteriovenous fistulas. Early means pt will get the procedure at 6 weeks from time of initiation of AVFs
arm group label: early angioplasty
other name: Early PTA
intervention type: Procedure
intervention name: late Angioplasty
description: Angioplasty is a minimally invasive, endovascular procedure to widen narrowed or obstructed arteries or veins. A deflated balloon attached to a catheter (a balloon catheter) is passed over a guide-wire into the narrowed vessel and then inflated to a fixed size. The balloon forces expansion of the blood vessel and the surrounding muscular wall, allowing an improved blood flow. This is part of standard of care for immature arteriovenous fistulas. Late means the angioplasty is done at 3 months from time of AVF creation if still immature at that time.
arm group label: late Angioplasty
other name: Late PTA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Al-Balas A, Lee T, Young CJ, Barker-Finkel J, Allon M. Predictors of Initiation for Predialysis Arteriovenous Fistula. Clin J Am Soc Nephrol. 2016 Oct 7;11(10):1802-1808. doi: 10.2215/CJN.00700116. Epub 2016 Sep 14.
PMID: 27630181
citation: Al-Balas A, Lee T, Young CJ, Kepes JA, Barker-Finkel J, Allon M. The Clinical and Economic Effect of Vascular Access Selection in Patients Initiating Hemodialysis with a Catheter. J Am Soc Nephrol. 2017 Dec;28(12):3679-3687. doi: 10.1681/ASN.2016060707. Epub 2017 Jul 14.
PMID: 28710090
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Alian Al-Balas
investigator title: Prinicipal investigator
mesh term: Arteriovenous Fistula
mesh term: Fistula