<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/NCT03001700</url>
  </required_header>
  <id_info>
    <org_study_id>CSP-0109</org_study_id>
    <nct_id>NCT03001700</nct_id>
  </id_info>
  <brief_title>PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE</brief_title>
  <acronym>PRELUDE</acronym>
  <official_title>PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE: PRELUDE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cagent Vascular LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cagent Vascular LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon&#xD;
      Catheter in subjects with atherosclerotic peripheral artery disease of the superficial&#xD;
      femoral and popliteal arteries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single Arm, prospective, OUS multi-center feasibility study enrolling up to 30 subjects with&#xD;
      superficial femoral or popliteal lesions. The study will capture acute angiographic data to&#xD;
      compare the pre- Serranator™ inflation vs post inflation effects.&#xD;
&#xD;
      The study population will consist of subjects with claudication or ischemic rest pain, with&#xD;
      de novo or non-stented restenotic lesions in femoropopliteal arteries having lesion length&#xD;
      less than or equal to 10 cm, total occlusion up to 6 cms in length and reference vessel&#xD;
      diameter of 4 mm to 6 mm, inclusive.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</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>To evaluate the technical feasibility of using the Serranator™ Alto PTA Serration Balloon Catheter during the endovascular treatment of critical SFA or popliteal artery lesions.</measure>
    <time_frame>Through Study Completion, approximately 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>OCT and/or IVUS imaging post use of the Serranator to document evidence of vessel wall serrations in a sub-set of up to 10 subjects.</measure>
    <time_frame>Through Study Completion, approximately 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be treated with the Serranator™ Alto PTA Serration Balloon Catheter device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Serranator™ Alto PTA Serration Balloon Catheter</intervention_name>
    <description>The Serranator™ is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female of &gt;18 years old.&#xD;
&#xD;
          2. Women of child bearing potential must have a negative pregnancy test within 7 days of&#xD;
             index procedure.&#xD;
&#xD;
          3. Subject or subject's legal representative has been informed of the nature of the&#xD;
             study, agrees to participate and comply with all follow-up visits and has signed the&#xD;
             consent form.&#xD;
&#xD;
          4. Resting ABI -&lt; 0.9.&#xD;
&#xD;
          5. Subject is eligible for standard surgical repair in target limb if necessary.&#xD;
&#xD;
          6. Subject has Rutherford Clinical Category 2,3, or 4&#xD;
&#xD;
          7. Estimated life expectancy &gt; 1 year.&#xD;
&#xD;
        Angiographic Inclusion Criteria:&#xD;
&#xD;
          1. Lesion(s) located within the SFA and or popliteal arteries.&#xD;
&#xD;
          2. Target lesion(s) has stenosis &gt;70% by visual assessment.&#xD;
&#xD;
          3. Reference vessel diameter is between 4.0mm and 6.0mm, inclusive.&#xD;
&#xD;
          4. One long or multiple serial lesions that are up to 10 cms, (total occlusions up to&#xD;
             6cm) in length that can be covered by a single balloon.&#xD;
&#xD;
          5. De-novo, or non-stented re-stenotic lesions&#xD;
&#xD;
          6. At least one below the knee artery patent to the ankle.&#xD;
&#xD;
          7. Successful treatment of iliac inflow stenosis to the target limb. Stenosis can be&#xD;
             treated during the same procedure using standard angioplasty and or stenting but use&#xD;
             of atherectomy is excluded. The inflow lesion(s) must be treated first, prior to&#xD;
             consideration of treatment of the target lesion. Subject can be enrolled if the inflow&#xD;
             lesion(s) are treated and results in &lt;30% residual stenosis and no evidence of&#xD;
             embolization or significant complications.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Rutherford Clinical Category 1, 5 or 6.&#xD;
&#xD;
          2. Previously implanted ipsilateral femoral or popliteal stent.&#xD;
&#xD;
          3. Evidence of aneurysm or acute thrombus in the target vessel.&#xD;
&#xD;
          4. Subjects with previous bypass surgery in lower target extremity.&#xD;
&#xD;
          5. Planned major amputation (above the ankle) of either limb.&#xD;
&#xD;
          6. Subject has significant stenosis or occlusion of inflow tract not successfully treated&#xD;
             (&gt;30% residual stenosis and/or significant complication of the procedure).&#xD;
&#xD;
          7. History of any open surgical procedure within the past 30 days.&#xD;
&#xD;
          8. Planned endovascular or vascular surgery procedure within 14 days prior to the ATK&#xD;
             procedure, except to treat the inflow vessels on the day of the procedure, or within&#xD;
             the next 30 days after the ATK procedure on the target limb.&#xD;
&#xD;
          9. Subject has an allergy to contrast medium that cannot be pretreated.&#xD;
&#xD;
         10. Episode of acute limb ischemia within past 30 days.&#xD;
&#xD;
         11. Subject has systemic infection with positive blood cultures/ bacteremia within one&#xD;
             week.&#xD;
&#xD;
         12. Subject has a hypercoagulable disorder&#xD;
&#xD;
         13. Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is&#xD;
             contraindicated.&#xD;
&#xD;
         14. Myocardial infarction within 30 days prior to enrollment.&#xD;
&#xD;
         15. History of stroke or TIA within 90 days prior to enrollment.&#xD;
&#xD;
         16. Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of&#xD;
             &gt;2.5 mg/dL or &gt;220 umol/L).&#xD;
&#xD;
         17. Subject is pregnant or breastfeeding.&#xD;
&#xD;
         18. Subject is participating in another research study of a device, medication, which&#xD;
             could, in the opinion of the investigator, affect the results of this study.&#xD;
&#xD;
         19. Subject has other medical, social or psychological problems that in the opinion of the&#xD;
             investigator would preclude them from receiving this treatment and the procedures and&#xD;
             or participating in evaluations pre- and post-treatment.&#xD;
&#xD;
         20. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where&#xD;
             complete resolution of the thrombus was not achieved.&#xD;
&#xD;
         21. Known allergies to both antiplatelet agents, aspirin, or heparin.&#xD;
&#xD;
         22. History of neutropenia, coagulopathy, or thrombocytopenia that was unexplained or is&#xD;
             considered to be at risk for reoccurrence.&#xD;
&#xD;
         23. Platelet count less than 80,000/μL,&#xD;
&#xD;
         24. Subject requires general anesthesia for the procedure.&#xD;
&#xD;
         25. Subject requires dialysis.&#xD;
&#xD;
        Angiographic Exclusion Criteria:&#xD;
&#xD;
          1. Chronic Total Occlusions (CTO) &gt; 6cm in length&#xD;
&#xD;
          2. Acute Total Occlusions; evidence of acute thrombus formation by angiography&#xD;
&#xD;
          3. Severe calcification of target lesion described as circumferential calcium and &gt;50% of&#xD;
             lesion length.&#xD;
&#xD;
          4. Sub-intimal access required&#xD;
&#xD;
          5. Inability to cross the lesion with a guidewire&#xD;
&#xD;
          6. Atherectomy in the target lesion, target artery or for inflow treatment&#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>Medizinische Universtität Graz</name>
      <address>
        <city>Graz</city>
        <zip>A-8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <state>Grafton</state>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polsko-Amerykańskie Kliniki Serca PAKS Małopolskie Centrum Sercowo Naczyniowe</name>
      <address>
        <city>Chrzanow</city>
        <zip>32-050</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki w Krakowie Pracownia Angiografii Oddział Angiologii</name>
      <address>
        <city>Krakow</city>
        <zip>31-066</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>New Zealand</country>
    <country>Poland</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>April 23, 2018</last_update_submitted>
  <last_update_submitted_qc>April 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2018</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>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 14, 2020</submitted>
    <returned>April 27, 2020</returned>
  </pending_results>
  <!-- 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/NCT03001700
org study id: CSP-0109
nct id: NCT03001700
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon
      Catheter in subjects with atherosclerotic peripheral artery disease of the superficial
      femoral and popliteal arteries.
Single Arm, prospective, OUS multi-center feasibility study enrolling up to 30 subjects with
      superficial femoral or popliteal lesions. The study will capture acute angiographic data to
      compare the pre- Serranator™ inflation vs post inflation effects.

      The study population will consist of subjects with claudication or ischemic rest pain, with
      de novo or non-stented restenotic lesions in femoropopliteal arteries having lesion length
      less than or equal to 10 cm, total occlusion up to 6 cms in length and reference vessel
      diameter of 4 mm to 6 mm, inclusive.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To evaluate the technical feasibility of using the Serranator™ Alto PTA Serration Balloon Catheter during the endovascular treatment of critical SFA or popliteal artery lesions.
time frame: Through Study Completion, approximately 6 months
measure: OCT and/or IVUS imaging post use of the Serranator to document evidence of vessel wall serrations in a sub-set of up to 10 subjects.
time frame: Through Study Completion, approximately 6 months
arm group label: Treatment
arm group type: Experimental
description: Subjects will be treated with the Serranator™ Alto PTA Serration Balloon Catheter device
intervention type: Device
intervention name: Serranator™ Alto PTA Serration Balloon Catheter
description: The Serranator™ is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Austria
country: New Zealand
country: Poland
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
sharing ipd: No
submitted: April 14, 2020
returned: April 27, 2020