<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/NCT04461717</url>
  </required_header>
  <id_info>
    <org_study_id>FLOW-Guard</org_study_id>
    <nct_id>NCT04461717</nct_id>
  </id_info>
  <brief_title>Micronet Covered Stent in in Arterial Locations Beyond the Carotid Bifurcation - FLOW-Guard Study</brief_title>
  <acronym>FLOW-Guard</acronym>
  <official_title>Prospective Observational Study of Procedures With MicroNet Covered Stent Use to Treat Increased Risk Lesions in Arterial Locations Beyond the Carotid Bifurcation - FLOW-Guard Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>John Paul II Hospital, Krakow</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>John Paul II Hospital, Krakow</source>
  <oversight_info>
    <has_dmc>No</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>
      Prospective observational study of MicroNet covered stent implantation in the elevated risk&#xD;
      peripheral lesions (high lesion load, thrombus containing, highly calcified).&#xD;
&#xD;
      Open-label, non randomized, single arm observational study. Jagiellonian University Medical&#xD;
      College research project.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peripheral artery stents in routine use (both balloon expandable and self-expendable) do not&#xD;
      sufficiently prevent distal embolization. They might induce a &quot;cheese-grater&quot; effect - a&#xD;
      consequence of their single layer design with uncovered space between stent struts.&#xD;
&#xD;
      Aim of the study is to evaluate short and long term safety and efficacy of MicroNet covered&#xD;
      stent implantation in the high risk lesions beyond the carotid bifurcation. Treatment&#xD;
      eligibility will be evaluated by a Vascular Team process (angiologist, vascular surgeon,&#xD;
      cardiologist). Optimal pharmacotherapy will be administered according to the current&#xD;
      guidelines.&#xD;
&#xD;
      Symptomatic and asymptomatic patients with peripheral artery disease requiring endovascular&#xD;
      treatment for high risk stenosis (soft plaque, highly calcific plaque) per Vascular Team&#xD;
      assessment.&#xD;
&#xD;
      A group of 30-50 consecutive patients meeting inclusion and exclusion criteria will be&#xD;
      enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 27, 2020</start_date>
  <completion_date type="Anticipated">February 28, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of procedural success</measure>
    <time_frame>Up to 48 hours after procedure or until hospital discharge, whichever came first.</time_frame>
    <description>Procedural success, defined as technical success (successful delivery and implantation of the stent) AND residual stenosis ≤ 30% of vessel lumen diameter AND clinical success (no peri-procedural complications)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of In-hospital MACNE (Major Adverse Cardiovascular or Neurological Events)</measure>
    <time_frame>Up to 48 hours after procedure or until hospital discharge, whichever came first.</time_frame>
    <description>In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of MACNE at 30 days</measure>
    <time_frame>At 30 days after procedure</time_frame>
    <description>MACNE at 30 days (death, stroke, myocardial infarction, acute limb or target organ ischemia)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of MACNE at 6 months</measure>
    <time_frame>At 6 months after procedure</time_frame>
    <description>MACNE at 6 months (death, stroke, myocardial infarction, acute limb or target organ ischemia)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of peri-procedural complications</measure>
    <time_frame>Up to 48 hours after procedure</time_frame>
    <description>Any peri-procedural complications until 48 hrs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at discharge</measure>
    <time_frame>24 hours after procedure</time_frame>
    <description>Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at 6 months</measure>
    <time_frame>At 6 months after procedure</time_frame>
    <description>Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel at 12 months</measure>
    <time_frame>At 12 months after procedure</time_frame>
    <description>Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vessel patency in CT angiography at 6 months</measure>
    <time_frame>At 6 months after procedure</time_frame>
    <description>Vessel patency in CT angiography (if not contraindicated) at 6 months</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Peripheral Vascular Diseases</condition>
  <arm_group>
    <arm_group_label>MicroNet covered stenting (interventional)</arm_group_label>
    <description>MicroNet covered stent implantation for increased risk arterial lesions beyond the carotid bifurcation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation</intervention_name>
    <description>Implantation of the MicroNet covered stent in the increased risk arterial lesions beyond the carotid bifurcation as per Vascular Team recommendation</description>
    <arm_group_label>MicroNet covered stenting (interventional)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with peripheral artery stenosis evaluated by Vascular Team with endovascular&#xD;
        treatment recommendation and high risk morphology plaque&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        General&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years, eligible for peripheral artery stenting after Vascular&#xD;
             Team evaluation, according to local standards&#xD;
&#xD;
          -  Written, informed consent to participate&#xD;
&#xD;
          -  Agreement to attend protocol required (standard) follow up visits and examinations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy &lt;1 year (e.g. active neoplastic disease).&#xD;
&#xD;
          -  Chronic kidney disease with creatinine &gt; 3.0 mg/dL.&#xD;
&#xD;
          -  Myocardial infarction in 72 hours proceeding the stenting procedure (if possible,&#xD;
             postponing the procedure)&#xD;
&#xD;
          -  Pregnancy (positive pregnancy test)&#xD;
&#xD;
          -  Coagulopathy.&#xD;
&#xD;
          -  History of uncontrolled contrast media intolerance&#xD;
&#xD;
        Angiographic&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  De novo lesion in major arteries or grafts connecting arteries&#xD;
&#xD;
          -  Stenosis eligible for endovascular treatment per Vascular Team evaluation (according&#xD;
             to current standards and guidelines)&#xD;
&#xD;
          -  High risk morphology stenosis (per 2 independent, experienced operators)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic total occlusion not amenable to re-canalization&#xD;
&#xD;
          -  Stent in the target vessel/lesion&#xD;
&#xD;
          -  Anatomic variants precluding stent implantation&#xD;
&#xD;
          -  Mobile (free-floating) plaque elements in aorta or arteries proximal to target lesion&#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>Piotr Musialek, MD, DPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>John Paul II Hospital, Krakow</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Piotr Musialek, MD, DPhil</last_name>
    <phone>+48126142287</phone>
    <email>p.musialek@szpitaljp2.krakow.pl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Cardiac and Vascular Diseases, The John Paul II Hospital</name>
      <address>
        <city>Kraków</city>
        <state>Maloplska</state>
        <zip>31-202</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Piotr Musialek, Prof</last_name>
      <phone>+48126142287</phone>
      <email>p.musialek@szpitaljp2.krakow.pl</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</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>Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Arterial Disease</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/NCT04461717
org study id: FLOW-Guard
nct id: NCT04461717
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective observational study of MicroNet covered stent implantation in the elevated risk
      peripheral lesions (high lesion load, thrombus containing, highly calcified).

      Open-label, non randomized, single arm observational study. Jagiellonian University Medical
      College research project.
Peripheral artery stents in routine use (both balloon expandable and self-expendable) do not
      sufficiently prevent distal embolization. They might induce a "cheese-grater" effect - a
      consequence of their single layer design with uncovered space between stent struts.

      Aim of the study is to evaluate short and long term safety and efficacy of MicroNet covered
      stent implantation in the high risk lesions beyond the carotid bifurcation. Treatment
      eligibility will be evaluated by a Vascular Team process (angiologist, vascular surgeon,
      cardiologist). Optimal pharmacotherapy will be administered according to the current
      guidelines.

      Symptomatic and asymptomatic patients with peripheral artery disease requiring endovascular
      treatment for high risk stenosis (soft plaque, highly calcific plaque) per Vascular Team
      assessment.

      A group of 30-50 consecutive patients meeting inclusion and exclusion criteria will be
      enrolled.
observational model: Cohort
time perspective: Prospective
measure: Rate of procedural success
time frame: Up to 48 hours after procedure or until hospital discharge, whichever came first.
description: Procedural success, defined as technical success (successful delivery and implantation of the stent) AND residual stenosis ≤ 30% of vessel lumen diameter AND clinical success (no peri-procedural complications)
measure: Number of In-hospital MACNE (Major Adverse Cardiovascular or Neurological Events)
time frame: Up to 48 hours after procedure or until hospital discharge, whichever came first.
description: In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)
measure: Number of MACNE at 30 days
time frame: At 30 days after procedure
description: MACNE at 30 days (death, stroke, myocardial infarction, acute limb or target organ ischemia)
measure: Number of MACNE at 6 months
time frame: At 6 months after procedure
description: MACNE at 6 months (death, stroke, myocardial infarction, acute limb or target organ ischemia)
measure: Rate of peri-procedural complications
time frame: Up to 48 hours after procedure
description: Any peri-procedural complications until 48 hrs
measure: Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at discharge
time frame: 24 hours after procedure
description: Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible)
measure: Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at 6 months
time frame: At 6 months after procedure
description: Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible)
measure: Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel at 12 months
time frame: At 12 months after procedure
description: Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible)
measure: Vessel patency in CT angiography at 6 months
time frame: At 6 months after procedure
description: Vessel patency in CT angiography (if not contraindicated) at 6 months
arm group label: MicroNet covered stenting (interventional)
description: MicroNet covered stent implantation for increased risk arterial lesions beyond the carotid bifurcation
intervention type: Device
intervention name: MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation
description: Implantation of the MicroNet covered stent in the increased risk arterial lesions beyond the carotid bifurcation as per Vascular Team recommendation
arm group label: MicroNet covered stenting (interventional)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Piotr Musialek, MD, DPhil
role: Principal Investigator
affiliation: John Paul II Hospital, Krakow
last name: Piotr Musialek, MD, DPhil
phone: +48126142287
email: p.musialek@szpitaljp2.krakow.pl
facility: 
status: Recruiting
contact: 
country: Poland
responsible party type: Sponsor
mesh term: Vascular Diseases
mesh term: Peripheral Vascular Diseases
mesh term: Peripheral Arterial Disease