<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/NCT02183194</url>
  </required_header>
  <id_info>
    <org_study_id>CL0021-01</org_study_id>
    <nct_id>NCT02183194</nct_id>
  </id_info>
  <brief_title>Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts</brief_title>
  <acronym>ACCESS</acronym>
  <official_title>A Prospective, MultiCenter, Single-arm, Post-market Study of Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts (ACCESS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>C. R. Bard</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>C. R. Bard</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter&#xD;
      (CE mark) for use as intended in the treatment of subjects with clinically significant&#xD;
      hemodialysis vascular access stenosis or occlusion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Slow recruitment&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy: Primary Patency</measure>
    <time_frame>6 months</time_frame>
    <description>Target Lesion Primary Patency (TLPP): The interval following index procedure intervention until the next reintervention of the target lesion or access thrombosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Primary Patency (TLPP)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Access circuit primary patency</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abandonment of permanent access in the index extremity</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of interventions required to maintain target lesion patency</measure>
    <time_frame>6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of interventions, required to maintain access circuit patency</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>The access circuit is defined as &quot;the area from the AV access graft arterial anastomosis to the superior vena-cava right atrial junction.&quot; The outcome is recording all interventions that occur in the access circuit up until the time of circuit failure (patency).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major vascular complications</measure>
    <time_frame>&lt; or at 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of device and procedure related adverse events</measure>
    <time_frame>1, 6 and 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Dysfunctional AV Graft</condition>
  <condition>Dysfunctional AV Fistula</condition>
  <arm_group>
    <arm_group_label>Lutonix Paclitaxel Drug Coated Balloon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lutonix Paclitaxel Drug Coated Balloon</intervention_name>
    <arm_group_label>Lutonix Paclitaxel Drug Coated Balloon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years&#xD;
&#xD;
          2. The subject is legally competent, has been informed of the nature, the scope and the&#xD;
             relevance of the study, voluntarily agrees to participation and the study's&#xD;
             provisions, and has duly signed the informed consent form (ICF)&#xD;
&#xD;
          3. Hemodialysis access on the arm presenting with any clinical abnormalities as defined&#xD;
             in the K/DOQI guidelines&#xD;
&#xD;
          4. Native AV fistula or synthetic AV graft has been implanted ≥30 days&#xD;
&#xD;
          5. Target de novo or non-stented restenotic lesion(s) consisting of a &gt;50% stenosis by&#xD;
             visual estimate. Successful treatment of non target lesion(s) (residual stenosis &lt;30%&#xD;
             by visual estimate) without procedural complication by standard of care&#xD;
&#xD;
          6. Successful predilatation of the target lesion with a percutaneous transluminal&#xD;
             angioplasty (PTA) balloon&#xD;
&#xD;
          7. Intended target lesion(s) (maximum of 2) can be treated&#xD;
&#xD;
          8. No other prior surgical or vascular interventions within 2 weeks before and/or planned&#xD;
             30 days after the treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who are pregnant, lactating, or planning on becoming pregnant or men intending&#xD;
             to father children&#xD;
&#xD;
          2. Known contraindication (including allergic reaction) or sensitivity to contrast media,&#xD;
             ASA, clopidogrel, ticlopidine, paclitaxel (mild to severe cases), that cannot be&#xD;
             adequately managed with pre-and post-procedure medication&#xD;
&#xD;
          3. Life expectancy &lt;12months&#xD;
&#xD;
          4. Scheduled for kidney transplant or peritoneal dialysis in the next 12months;&#xD;
&#xD;
          5. Thrombosed access&#xD;
&#xD;
          6. Stent in the target treatment area&#xD;
&#xD;
          7. Blood coagulative disorder, sepsis, or current AV access infection&#xD;
&#xD;
          8. Currently participating in an investigational drug, biologic, or device study, or&#xD;
             previous enrollment in this study NOTE: Enrollment in another investigational drug,&#xD;
             biologic, or device study during the follow- up period is not allowed&#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>LKH-Univ. Klinikum Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Klagenfurt am Wörthersee</name>
      <address>
        <city>Klagenfurt</city>
        <zip>9020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Köln AöR</name>
      <address>
        <city>Koln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein - Campus Lübeck</name>
      <address>
        <city>Lubeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>June 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>February 1, 2016</last_update_submitted>
  <last_update_submitted_qc>February 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
  </intervention_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/NCT02183194
org study id: CL0021-01
nct id: NCT02183194
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter
      (CE mark) for use as intended in the treatment of subjects with clinically significant
      hemodialysis vascular access stenosis or occlusion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy: Primary Patency
time frame: 6 months
description: Target Lesion Primary Patency (TLPP): The interval following index procedure intervention until the next reintervention of the target lesion or access thrombosis.
measure: Target Lesion Primary Patency (TLPP)
time frame: 12 months
measure: Access circuit primary patency
time frame: 6 and 12 months
measure: Abandonment of permanent access in the index extremity
time frame: 6 and 12 months
measure: Number of interventions required to maintain target lesion patency
time frame: 6 and 12 months
measure: Number of interventions, required to maintain access circuit patency
time frame: 6 and 12 months
description: The access circuit is defined as "the area from the AV access graft arterial anastomosis to the superior vena-cava right atrial junction." The outcome is recording all interventions that occur in the access circuit up until the time of circuit failure (patency).
measure: Major vascular complications
time frame: < or at 1 month
measure: Rate of device and procedure related adverse events
time frame: 1, 6 and 12 months
arm group label: Lutonix Paclitaxel Drug Coated Balloon
arm group type: Experimental
intervention type: Device
intervention name: Lutonix Paclitaxel Drug Coated Balloon
arm group label: Lutonix Paclitaxel Drug Coated Balloon
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Germany
responsible party type: Sponsor
mesh term: Arteriovenous Fistula
mesh term: Fistula
mesh term: Paclitaxel