<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/NCT03751527</url>
  </required_header>
  <id_info>
    <org_study_id>201805</org_study_id>
    <nct_id>NCT03751527</nct_id>
  </id_info>
  <brief_title>ZENFlex-Registry to Evaluate the Outcome of Bare Metal Stent-assisted Angioplasty</brief_title>
  <official_title>ZENFlex-Registry to Evaluate the Outcome of Bare Metal Stent-assisted Angioplasty in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Zylox Medical Device Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang Zylox Medical Device Co., Ltd.</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>
      A prospective, multi-center, single-arm registry to evaluate the safety and efficacy of bare&#xD;
      metal stent-assisted percutaneous transluminal angioplasty (PTA) in the treatment of&#xD;
      superficial femoral and/or proximal popliteal artery (P1) lesions in patients with&#xD;
      symptomatic peripheral artery disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this registry is to collect acute and follow-up (up to 12 months) safety and&#xD;
      efficacy data on the ZENFlex™ Peripheral Stent System in the stent-assisted angioplasty&#xD;
      treatment of patients with de novo or restenotic lesion(s) of the native superficial femoral&#xD;
      artery (SFA) and/or proximal popliteal artery (PPA, P1 segment) when used according to IFU.&#xD;
      Up to 100 subjects will be enrolled in this study at up to 5 sites in Germany.&#xD;
&#xD;
      This study is a prospective, single-arm observational registry and does not include an active&#xD;
      control arm. Therefore, no formal sample size calculation has been performed. All subjects&#xD;
      will be evaluated at pre-discharge and during clinical follow-up visits 6 (182 ± 30 days) and&#xD;
      12 (365 ± 30 days) months post-procedure.&#xD;
&#xD;
      Primary endpoints are patency rate after one year and composite of freedom from device and&#xD;
      procedure-related death through 12 months post procedure as well as freedom from both target&#xD;
      limb major amputation and clinically-driven target lesion revascularization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 31, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Patency rate</measure>
    <time_frame>12 (365 ± 30 days) months</time_frame>
    <description>patency rate after one year defined as absence of clinically driven TLR (due to symptoms and drop of ABI of ≥ 20% or &gt; 0.15 when compared to post-procedure baseline) or restenosis with PVR &gt; 2.4 evaluated by Duplex Ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Procedure-related death</measure>
    <time_frame>12 (365 ± 30 days) months</time_frame>
    <description>Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target lesion revascularization。</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TLR rate at 6 and 12months</measure>
    <time_frame>6 (182 ± 30 days) and 12 (365 ± 30 days) months</time_frame>
    <description>The ratio of either repeat percutaneous or surgical revascularization for target lesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained clinical improvement</measure>
    <time_frame>12 (365 ± 30 days) months</time_frame>
    <description>an improvement shift in the Rutherford classification of one class in amputation and TVR free surviving patients at 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WIQ at 6 and 12 months</measure>
    <time_frame>6 (182 ± 30 days) and 12 (365 ± 30 days) months</time_frame>
    <description>Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6 and 12 months vs. baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duplex-defined binary restenosis (PSVR &gt;2.4) at 6 and 12 months or at any time of re-intervention</measure>
    <time_frame>6 (182 ± 30 days) and 12 (365 ± 30 days) months</time_frame>
    <description>Duplex-defined binary restenosis (PSVR &gt;2.4) of the target lesion post-procedure and at 6 and 12 months or at any time of re-intervention</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Atherosclerosis of Femoral Artery</condition>
  <arm_group>
    <arm_group_label>ZENFLEX stent Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects applying ZENFLEX peripheral stent system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ZENFLEX peripheral stent system</intervention_name>
    <description>The ZENFLEX Peripheral Stent System is designed to deliver a self-expanding stent to the iliac artery, superficial femoral arteries and / or proximal popliteal arteries to improve luminal diameter. The self-expanding stent is composed of nickel titanium alloy (nitinol); contains a total of 12 tantalum / gold radiopaque markers and imparts an outward radial force on the luminal surface of the vessel to establish patency.</description>
    <arm_group_label>ZENFLEX stent Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Patient is ≥ 18 years old at the time of consent. 2. Subject has provided written&#xD;
             informed consent prior to participation in the study, understands the purpose of this&#xD;
             study and agrees to comply with all protocol-specified examinations and follow-up&#xD;
             appointments.&#xD;
&#xD;
             3. Rutherford Classification Category 2-4. Subjects with Rutherford Class 2 have gone&#xD;
             through a conservative therapy without success. 4. De novo stenotic, restenotic or&#xD;
             occlusive lesion(s) located in the superficial femoral artery and/or proximal&#xD;
             popliteal artery (P1 segment) suitable for stenting after PTA.&#xD;
&#xD;
             5. Lesion location starts distal to CFA bifurcation (below origin of deep femoral&#xD;
             artery) and should not extend beyond the P1 segment of the popliteal artery.&#xD;
&#xD;
             6. Lesion(s) is/are located at least 2 cm from any stent if target limb was already&#xD;
             previously stented.&#xD;
&#xD;
             7. &gt;70 % diameter stenosis or occlusion by visual angiographic estimate. 8. Patent&#xD;
             inflow (treatment of inflow is allowed before treatment of the target lesion if&#xD;
             successful).&#xD;
&#xD;
             9. Patent ipsilateral popliteal artery (P2 and P3 segments) and at least 1 patent&#xD;
             infrapopliteal artery in continuity to ankle. 10. Target reference vessel diameter ≥ 4&#xD;
             - ≤ 7.0 mm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded from the registry if any of the following criteria is met:&#xD;
&#xD;
               1. Target Lesion previously tested with a stent or surgery.&#xD;
&#xD;
               2. Rutherford Classification Category 0, 1, 5 or 6.&#xD;
&#xD;
               3. Inability to tolerate antithrombotic or antiplatelet therapies.&#xD;
&#xD;
               4. Known allergy or contraindication to contrast medium that, in the opinion of the&#xD;
                  investigator, can't be adequately pre-medicated.&#xD;
&#xD;
               5. Non-dilatable severely calcified lesion.&#xD;
&#xD;
               6. Known hypersensitivity to nitinol and/or its components (e.g. nickel, titanium).&#xD;
&#xD;
               7. Acute or subacute thrombus in the target lesion.&#xD;
&#xD;
               8. Documented life expectancy &lt; 13 months&#xD;
&#xD;
               9. Pregnancy or female patient with child bearing potential not taking adequate&#xD;
                  contraceptives or currently breastfeeding.&#xD;
&#xD;
              10. Other comorbidity risks which in the opinion of the investigator limit longevity&#xD;
                  or likelihood of compliance with protocol follow up.&#xD;
&#xD;
              11. Myocardial infarction or stroke within 90 days prior to index procedure.&#xD;
&#xD;
              12. Hypercoagulable state.&#xD;
&#xD;
              13. Patient is currently enrolled in any other clinical investigational trial(s).&#xD;
&#xD;
              14. Use of alternative therapy in target lesion during index procedure, e.g.&#xD;
                  atherectomy, lysis therapy, laser therapy, DES, re-entry-devices, cutting /&#xD;
                  scoring balloon&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dierk Scheinert</last_name>
    <role>Study Director</role>
    <affiliation>Universitätsklinikum Leipzig</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Annett Glanz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Diakoniekrankenhaus Halle</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Summer Zheng, Bachelor</last_name>
    <phone>+8613601399119</phone>
    <email>summer.zheng@zyloxmedical.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jie Liang, Bachelor</last_name>
    <phone>+8613819565660</phone>
    <email>jie.liang@zyloxmedical.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Popescu Diakoniekrankenhaus Halle gGmbH Klinik für Innere Medizin</name>
      <address>
        <city>Halle</city>
        <zip>06114</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Corneliu Gheorghe, Phd. med</last_name>
      <phone>+49(0)345 778 6344</phone>
    </contact>
    <investigator>
      <last_name>Corneliu Gheorghe</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>August 29, 2021</last_update_submitted>
  <last_update_submitted_qc>August 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2021</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>Atherosclerosis</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/NCT03751527
org study id: 201805
nct id: NCT03751527
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A prospective, multi-center, single-arm registry to evaluate the safety and efficacy of bare
      metal stent-assisted percutaneous transluminal angioplasty (PTA) in the treatment of
      superficial femoral and/or proximal popliteal artery (P1) lesions in patients with
      symptomatic peripheral artery disease
The purpose of this registry is to collect acute and follow-up (up to 12 months) safety and
      efficacy data on the ZENFlex™ Peripheral Stent System in the stent-assisted angioplasty
      treatment of patients with de novo or restenotic lesion(s) of the native superficial femoral
      artery (SFA) and/or proximal popliteal artery (PPA, P1 segment) when used according to IFU.
      Up to 100 subjects will be enrolled in this study at up to 5 sites in Germany.

      This study is a prospective, single-arm observational registry and does not include an active
      control arm. Therefore, no formal sample size calculation has been performed. All subjects
      will be evaluated at pre-discharge and during clinical follow-up visits 6 (182 ± 30 days) and
      12 (365 ± 30 days) months post-procedure.

      Primary endpoints are patency rate after one year and composite of freedom from device and
      procedure-related death through 12 months post procedure as well as freedom from both target
      limb major amputation and clinically-driven target lesion revascularization.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patency rate
time frame: 12 (365 ± 30 days) months
description: patency rate after one year defined as absence of clinically driven TLR (due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure baseline) or restenosis with PVR > 2.4 evaluated by Duplex Ultrasound
measure: Procedure-related death
time frame: 12 (365 ± 30 days) months
description: Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target lesion revascularization。
measure: TLR rate at 6 and 12months
time frame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months
description: The ratio of either repeat percutaneous or surgical revascularization for target lesions
measure: Sustained clinical improvement
time frame: 12 (365 ± 30 days) months
description: an improvement shift in the Rutherford classification of one class in amputation and TVR free surviving patients at 12 months.
measure: WIQ at 6 and 12 months
time frame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months
description: Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6 and 12 months vs. baseline
measure: Duplex-defined binary restenosis (PSVR >2.4) at 6 and 12 months or at any time of re-intervention
time frame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months
description: Duplex-defined binary restenosis (PSVR >2.4) of the target lesion post-procedure and at 6 and 12 months or at any time of re-intervention
arm group label: ZENFLEX stent Group
arm group type: Experimental
description: subjects applying ZENFLEX peripheral stent system
intervention type: Device
intervention name: ZENFLEX peripheral stent system
description: The ZENFLEX Peripheral Stent System is designed to deliver a self-expanding stent to the iliac artery, superficial femoral arteries and / or proximal popliteal arteries to improve luminal diameter. The self-expanding stent is composed of nickel titanium alloy (nitinol); contains a total of 12 tantalum / gold radiopaque markers and imparts an outward radial force on the luminal surface of the vessel to establish patency.
arm group label: ZENFLEX stent Group
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dierk Scheinert
role: Study Director
affiliation: Universitätsklinikum Leipzig
last name: Annett Glanz
role: Principal Investigator
affiliation: Diakoniekrankenhaus Halle
last name: Summer Zheng, Bachelor
phone: +8613601399119
email: summer.zheng@zyloxmedical.com
last name: Jie Liang, Bachelor
phone: +8613819565660
email: jie.liang@zyloxmedical.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Atherosclerosis
sharing ipd: No