<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/NCT01728441</url>
  </required_header>
  <id_info>
    <org_study_id>Prov 01-2012</org_study_id>
    <secondary_id>U1111-1136-8610</secondary_id>
    <nct_id>NCT01728441</nct_id>
  </id_info>
  <brief_title>Evaluation of Paclitaxel Eluting Stent vs Paclitaxel Eluting Balloon Treating Peripheral Artery Disease of the Femoral Artery</brief_title>
  <official_title>REAL PTX - Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Provascular GmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>William Cook Europe</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Provascular GmbH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective of the REAL PTX trial is to compare paclitaxel-eluting stents to paclitaxel-eluting&#xD;
      balloons for treating symptomatic peripheral artery disease of the femoropopliteal artery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The REAL PTX trial has been designed as prospective, randomized, multi-center, post-market&#xD;
      study investigating the effect of the paclitaxel-eluting stent Zilver® PTX® (DES)in&#xD;
      comparison to the use of a paclitaxel eluting balloon (DEB)in treating symptomatic peripheral&#xD;
      artery disease of the femoropopliteal artery.&#xD;
&#xD;
      Up to 150 patients will be enrolled in Germany and Belgium. Enrollment is expected to be&#xD;
      completed within approximately six months of initiating the study.&#xD;
&#xD;
      One group (DES or DEB) will be considered to yield significantly better results of the&#xD;
      primary patency rate than the other group at 12 months follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Peak Systolic Velocity Ratio (PSVR)</measure>
    <time_frame>12 months</time_frame>
    <description>The primary outcome will be the one-year primary patency rate (Kaplan-Meier estimate at 12 months).Primary patency is defined as absence of clinically-driven target lesion revascularization (TLR) or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) &gt; 2.4 as evaluated by duplex ultrasound core laboratory analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>target lesion revascularization (TLR)</measure>
    <time_frame>12 months</time_frame>
    <description>The primary outcome will be the one-year primary patency rate (Kaplan-Meier estimate at 12 months).Primary patency is defined as absence of clinically-driven target lesion revascularization (TLR) or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) &gt; 2.4 as evaluated by duplex ultrasound core laboratory analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Events (MAEs)</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>MAE is defined as:&#xD;
Death within 30 days of the index procedure or within 30 days of a target lesion revascularization (TLR)&#xD;
Clinically-driven TLR, or&#xD;
Major target limb amputation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All cause death</measure>
    <time_frame>6, 12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel revascularization (TVR)</measure>
    <time_frame>6, 12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically-driven target lesion revascularization (TLR)</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>Clinically-driven TLR is defined as a reintervention performed for ≥ 50% diameter stenosis (confirmed by angiography) within ± 5 mm proximal and/or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral artery disease (PAD) following the initial procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major target limb amputation within 6, 12 and 24 months. Major target limb Major target limb amputation</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>Major target limb amputation is defined as amputation of the target leg other than amputation of the toe(s).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained clinical improvement</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>Sustained clinical improvement is defined as an improvement in the Rutherford category of one class compared to baseline in surviving patients who are free from major target limb amputation and free from target lesion revascularization (TLR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binary restenosis</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>Binary restenosis (Peak Systolic Velocity Ratio (PSVR) &gt;2.4)of the target lesion at 6, 12 and 24 months or at the time of reintervention prior to any pre-specified time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking capacity</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>Walking capacity assessment by walking impairment questionnaire (WIQ) at 6, 12 and 24 months or at the time of reintervention prior to any pre-specified time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural success</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>Procedural success is defined as obtainment of &lt; 30% residual stenosis on angiography by visual estimate.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <arm_group>
    <arm_group_label>Paclitaxel Eluting Stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to treatment with paclitaxel eluting stent will receive the Zilver® PTX® stent.Primary stenting should be performed covering the full lesion. Post-dilatation is at the investigator's discretion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paclitaxel Eluting Balloon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For patients randomized to treatment with drug eluting balloon (DEB), angioplasty (ballooning) should be performed covering the full lesion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Paclitaxel Eluting Stent</intervention_name>
    <arm_group_label>Paclitaxel Eluting Stent</arm_group_label>
    <other_name>Zilver PTX stent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Paclitaxel Eluting Balloon</intervention_name>
    <arm_group_label>Paclitaxel Eluting Balloon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject age ≥ 18&#xD;
&#xD;
          -  Subject has been informed of the nature of the study, agrees to participate, and has&#xD;
             signed a Medical Ethics Committee approved consent form.&#xD;
&#xD;
          -  Subject understands the duration of the study, agrees to attend follow-up visits, and&#xD;
             agrees to complete the required testing.&#xD;
&#xD;
          -  Rutherford category 2-5.&#xD;
&#xD;
          -  Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented&#xD;
             angiographically and no prior stent in the target lesion.&#xD;
&#xD;
          -  Target lesion is at least 1cm below the origin of the profunda femoris and does not&#xD;
             exceed the medial femoral epicondyle.&#xD;
&#xD;
          -  A single target lesion (stenotic areas separated by more than 3 cm with ≤ 30% stenosis&#xD;
             might, at the decision of the investigator, be considered as 2 lesions).&#xD;
&#xD;
          -  Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual assessment.&#xD;
&#xD;
          -  Patency of at least one (1) infrapopliteal artery to the ankle (&lt; 50% diameter&#xD;
             stenosis) in continuity with the native femoropopliteal artery.&#xD;
&#xD;
          -  A guidewire has successfully traversed the target treatment segment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Clinical exclusion criteria&#xD;
&#xD;
          -  Inability to obtain informed consent.&#xD;
&#xD;
          -  Life expectancy &lt; 12 months.&#xD;
&#xD;
          -  Pregnancy, suspected pregnancy, or breastfeeding during study period (patients of&#xD;
             childbearing potential must have negative serum pregnancy test 7 days prior to&#xD;
             treatment).&#xD;
&#xD;
          -  Presence of one or more of the following co-morbid factors: hemodialysis dependence,&#xD;
             renal insufficiency with a serum creatinine ≥ 2.5 mg/dl, cerebrovascular accident&#xD;
             (CVA) within 1 month of procedure or any CVA resulting in unresolved walking&#xD;
             impairment, and/or myocardial infarction (MI) within 1 month of procedure.&#xD;
&#xD;
          -  Any evidence of hemodynamic instability prior to procedure/randomization.&#xD;
&#xD;
          -  Coagulopathy or clotting disorders.&#xD;
&#xD;
          -  Present or suspected systemic infection or osteomyelitis affecting target limb.&#xD;
&#xD;
          -  Contraindication to contrast media or any study-required medication (antiplatelets,&#xD;
             anticoagulants, thrombolytics, etc).&#xD;
&#xD;
          -  Hypersensitivity to nitinol and/or paclitaxel.&#xD;
&#xD;
          -  Enrollment into another study.&#xD;
&#xD;
          -  Intervention of the target lesion less than 90 days prior of the study procedure.&#xD;
&#xD;
        Anatomic Exclusion Criteria:&#xD;
&#xD;
          -  Untreated external iliac artery inflow lesion (study allows for successful treatment&#xD;
             prior to study treatment procedures).&#xD;
&#xD;
          -  Total occlusion uncrossable by a conventional guidewire.&#xD;
&#xD;
          -  Acute occlusive intraluminal thrombosis of the proposed lesion site.&#xD;
&#xD;
          -  Evidence of an aneurysm at the target lesion site.&#xD;
&#xD;
          -  Perforation in the target vessel as evidenced by the extravasation of contrast.&#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>Dierk Scheinert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Park Hospital Leipzig</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Imelda Hospital</name>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Blasius Department of Vascular Surgery</name>
      <address>
        <city>Dendermonde</city>
        <zip>9200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäts Herzzentrum Freiburg Bad Krozingen Abteilung Angiologie</name>
      <address>
        <city>Bad Krozingen</city>
        <zip>79189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Angiologikum Hamburg Centre for Interventional Vascular Medicine</name>
      <address>
        <city>Hamburg</city>
        <zip>22527</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Park-Krankenhaus Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <last_update_submitted>May 19, 2014</last_update_submitted>
  <last_update_submitted_qc>May 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PAD</keyword>
  <keyword>stenting</keyword>
  <keyword>angioplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound 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/NCT01728441
org study id: Prov 01-2012
secondary id: U1111-1136-8610
nct id: NCT01728441
lead sponsor: 
collaborator: 
has dmc: Yes
Objective of the REAL PTX trial is to compare paclitaxel-eluting stents to paclitaxel-eluting
      balloons for treating symptomatic peripheral artery disease of the femoropopliteal artery.
The REAL PTX trial has been designed as prospective, randomized, multi-center, post-market
      study investigating the effect of the paclitaxel-eluting stent Zilver® PTX® (DES)in
      comparison to the use of a paclitaxel eluting balloon (DEB)in treating symptomatic peripheral
      artery disease of the femoropopliteal artery.

      Up to 150 patients will be enrolled in Germany and Belgium. Enrollment is expected to be
      completed within approximately six months of initiating the study.

      One group (DES or DEB) will be considered to yield significantly better results of the
      primary patency rate than the other group at 12 months follow up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peak Systolic Velocity Ratio (PSVR)
time frame: 12 months
description: The primary outcome will be the one-year primary patency rate (Kaplan-Meier estimate at 12 months).Primary patency is defined as absence of clinically-driven target lesion revascularization (TLR) or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) > 2.4 as evaluated by duplex ultrasound core laboratory analysis.
measure: target lesion revascularization (TLR)
time frame: 12 months
description: The primary outcome will be the one-year primary patency rate (Kaplan-Meier estimate at 12 months).Primary patency is defined as absence of clinically-driven target lesion revascularization (TLR) or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) > 2.4 as evaluated by duplex ultrasound core laboratory analysis.
measure: Major Adverse Events (MAEs)
time frame: 6, 12 and 24 months
description: MAE is defined as:
Death within 30 days of the index procedure or within 30 days of a target lesion revascularization (TLR)
Clinically-driven TLR, or
Major target limb amputation.
measure: All cause death
time frame: 6, 12 and 24 months
measure: Target vessel revascularization (TVR)
time frame: 6, 12 and 24 months
measure: Clinically-driven target lesion revascularization (TLR)
time frame: 6, 12 and 24 months
description: Clinically-driven TLR is defined as a reintervention performed for ≥ 50% diameter stenosis (confirmed by angiography) within ± 5 mm proximal and/or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral artery disease (PAD) following the initial procedure.
measure: Major target limb amputation within 6, 12 and 24 months. Major target limb Major target limb amputation
time frame: 6, 12 and 24 months
description: Major target limb amputation is defined as amputation of the target leg other than amputation of the toe(s).
measure: Sustained clinical improvement
time frame: 6, 12 and 24 months
description: Sustained clinical improvement is defined as an improvement in the Rutherford category of one class compared to baseline in surviving patients who are free from major target limb amputation and free from target lesion revascularization (TLR).
measure: Binary restenosis
time frame: 6, 12 and 24 months
description: Binary restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)of the target lesion at 6, 12 and 24 months or at the time of reintervention prior to any pre-specified time point.
measure: Walking capacity
time frame: 6, 12 and 24 months
description: Walking capacity assessment by walking impairment questionnaire (WIQ) at 6, 12 and 24 months or at the time of reintervention prior to any pre-specified time point.
measure: Procedural success
time frame: 6, 12 and 24 months
description: Procedural success is defined as obtainment of < 30% residual stenosis on angiography by visual estimate.
arm group label: Paclitaxel Eluting Stent
arm group type: Experimental
description: Patients randomized to treatment with paclitaxel eluting stent will receive the Zilver® PTX® stent.Primary stenting should be performed covering the full lesion. Post-dilatation is at the investigator's discretion.
arm group label: Paclitaxel Eluting Balloon
arm group type: Active Comparator
description: For patients randomized to treatment with drug eluting balloon (DEB), angioplasty (ballooning) should be performed covering the full lesion.
intervention type: Device
intervention name: Paclitaxel Eluting Stent
arm group label: Paclitaxel Eluting Stent
other name: Zilver PTX stent
intervention type: Device
intervention name: Paclitaxel Eluting Balloon
arm group label: Paclitaxel Eluting Balloon
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dierk Scheinert, MD
role: Principal Investigator
affiliation: Park Hospital Leipzig
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Germany
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel