<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/NCT03811925</url>
  </required_header>
  <id_info>
    <org_study_id>STRAtiFy_CR</org_study_id>
    <nct_id>NCT03811925</nct_id>
  </id_info>
  <brief_title>SFA TReatment and vAscular Functions</brief_title>
  <acronym>STRAtiFy</acronym>
  <official_title>Local and Systemic Vascular Function Following Drug Coated Balloon vs. Stenting in the Superficial Femoral Artery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Essen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Essen</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>
      Endovascular treatment of the superficial femoral artery has a high initial success rate, but&#xD;
      restenosis occurs in up to 60% of cases. While restoration of tissue perfusion is achieved,&#xD;
      interventional strategies affect endothelial function. Endothelial dysfunction is the&#xD;
      pathophysiologic principle involved in the initiation and progression of arteriosclerosis.&#xD;
&#xD;
      The aim of this study is to determine the impact of endovascular strategies in the&#xD;
      superficial femoral artery on local and systemic endothelial and vascular function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>local endothelial function</measure>
    <time_frame>6 months Follow Up</time_frame>
    <description>Change of endothelial function, assessed by the change in the vasodilatative reserve of the femoral artery (flow-mediated dilation = FMD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systemic endothelial function</measure>
    <time_frame>6 months Follow Up</time_frame>
    <description>1.Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vessel stiffness</measure>
    <time_frame>6 months Follow Up</time_frame>
    <description>Vascular stiffness determined through pulse wave velocity (PWV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary patency</measure>
    <time_frame>6 months Follow Up</time_frame>
    <description>determined through doppler ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>target lesion revascularization</measure>
    <time_frame>6 months Follow Up</time_frame>
    <description>freedom from Target Lesion Revascularization (FTLR) is defined as the Need for percutaneous or interventional revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ABI (Ankle Brachial Index)</measure>
    <time_frame>6 months Follow Up</time_frame>
    <description>Ankle Brachial Index assessed by Doppler</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Claudication, Intermittent</condition>
  <arm_group>
    <arm_group_label>DCB</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Stenting</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Angioplasty and drug coated balloon of the superficial femoral artery (SFA)</intervention_name>
    <description>In case of drug coated balloon (DCB) there should be always a predilation of the lesion with a predefined ballon (180 sec, Passeo-18). Thus, no direct DCB will be conducted. All DCB lengths (40mm to 200 mm) and Diameters (3mm to 7mm) are eligible for the Trial as long as used in the superficial femoral artery (SFA)</description>
    <arm_group_label>DCB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Angioplasty and stenting of the superficial femoral artery (SFA)</intervention_name>
    <description>In case of stent application there should be always a predilation of the lesion with a predefined ballon (180 sec, Passeo-18). In case of stenting there should be a strong effect on vasomotion of the treated vessel area. All Stent lengths (40mm to 200 mm) and Diameters (5mm to 7mm) are eligible for the trial as long as used in the superficial femoral artery (SFA)</description>
    <arm_group_label>Stenting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by&#xD;
             Rutherford 2, 3, 4, or 5&#xD;
&#xD;
          -  Planed peripheral intervention TASC A-C&#xD;
&#xD;
          -  Subject must be between 40 and 85 years old&#xD;
&#xD;
          -  Female of childbearing potential must have a negative pregnancy test within 10 days&#xD;
             prior to index procedure and utilize reliable birth control until completion of the&#xD;
             12-month angiographic evaluation&#xD;
&#xD;
          -  Guidewire must cross lesion(s) within the true lumen, without a relevant sub-intimal&#xD;
             course&#xD;
&#xD;
          -  Vessel diameter ≥3.0 mm and ≤6.0 mm&#xD;
&#xD;
          -  Willing to comply with the specified follow-up evaluation&#xD;
&#xD;
          -  Written informed consent prior to any study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lesions TASC D&#xD;
&#xD;
          -  Angiographic evidence of thrombus within target vessel&#xD;
&#xD;
          -  Thrombolysis within 72 hours prior to the index procedure&#xD;
&#xD;
          -  Aneurysm in the femoral artery or popliteal artery&#xD;
&#xD;
          -  Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or&#xD;
             receiving immunosuppressant therapy&#xD;
&#xD;
          -  Unstable angina pectoris at the time of the enrollment&#xD;
&#xD;
          -  Recent myocardial infarction or stroke &lt; 30 days prior to the index procedure&#xD;
&#xD;
          -  Life expectancy less than 12 months&#xD;
&#xD;
          -  Septicemia at the time of enrollment&#xD;
&#xD;
          -  Known or suspected active infection at the time of the index procedure, excluding an&#xD;
             infection of a lower extremity wound of the target limb&#xD;
&#xD;
          -  Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin&#xD;
&#xD;
          -  Presence of other hemodynamically significant outflow lesions in the target limb&#xD;
             requiring a planned surgical intervention or endovascular procedure within 30 days&#xD;
             after the index procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Christos Rammos, MD</last_name>
    <phone>020172384808</phone>
    <email>Christos.Rammos@uk-essen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christos Rammos</last_name>
    <phone>020172384808</phone>
    <email>Christos.Rammos@uk-essen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Essen</name>
      <address>
        <city>Essen</city>
        <state>NRW</state>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fadi Al-Rashid, Dr.med.</last_name>
      <phone>00492017230</phone>
      <email>fadi.al-rashid@uk-essen.de</email>
    </contact>
    <investigator>
      <last_name>Christos Rammos, MD, PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Essen</investigator_affiliation>
    <investigator_full_name>Fadi Al-Rashid</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>
    <mesh_term>Intermittent Claudication</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/NCT03811925
org study id: STRAtiFy_CR
nct id: NCT03811925
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endovascular treatment of the superficial femoral artery has a high initial success rate, but
      restenosis occurs in up to 60% of cases. While restoration of tissue perfusion is achieved,
      interventional strategies affect endothelial function. Endothelial dysfunction is the
      pathophysiologic principle involved in the initiation and progression of arteriosclerosis.

      The aim of this study is to determine the impact of endovascular strategies in the
      superficial femoral artery on local and systemic endothelial and vascular function.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: local endothelial function
time frame: 6 months Follow Up
description: Change of endothelial function, assessed by the change in the vasodilatative reserve of the femoral artery (flow-mediated dilation = FMD)
measure: Systemic endothelial function
time frame: 6 months Follow Up
description: 1.Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)
measure: Vessel stiffness
time frame: 6 months Follow Up
description: Vascular stiffness determined through pulse wave velocity (PWV)
measure: Primary patency
time frame: 6 months Follow Up
description: determined through doppler ultrasound
measure: target lesion revascularization
time frame: 6 months Follow Up
description: freedom from Target Lesion Revascularization (FTLR) is defined as the Need for percutaneous or interventional revascularization
measure: ABI (Ankle Brachial Index)
time frame: 6 months Follow Up
description: Ankle Brachial Index assessed by Doppler
arm group label: DCB
arm group type: Other
arm group label: Stenting
arm group type: Other
intervention type: Procedure
intervention name: Angioplasty and drug coated balloon of the superficial femoral artery (SFA)
description: In case of drug coated balloon (DCB) there should be always a predilation of the lesion with a predefined ballon (180 sec, Passeo-18). Thus, no direct DCB will be conducted. All DCB lengths (40mm to 200 mm) and Diameters (3mm to 7mm) are eligible for the Trial as long as used in the superficial femoral artery (SFA)
arm group label: DCB
intervention type: Procedure
intervention name: Angioplasty and stenting of the superficial femoral artery (SFA)
description: In case of stent application there should be always a predilation of the lesion with a predefined ballon (180 sec, Passeo-18). In case of stenting there should be a strong effect on vasomotion of the treated vessel area. All Stent lengths (40mm to 200 mm) and Diameters (5mm to 7mm) are eligible for the trial as long as used in the superficial femoral artery (SFA)
arm group label: Stenting
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Christos Rammos, MD
phone: 020172384808
email: Christos.Rammos@uk-essen.de
last name: Christos Rammos
phone: 020172384808
email: Christos.Rammos@uk-essen.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Essen
investigator full name: Fadi Al-Rashid
investigator title: Principal Investigator
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Intermittent Claudication
sharing ipd: No