<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/NCT03248323</url>
  </required_header>
  <id_info>
    <org_study_id>A03968</org_study_id>
    <nct_id>NCT03248323</nct_id>
  </id_info>
  <brief_title>A Prospective Study: the Value of Using iFlow and PBV in the Endovascular Treatment of Infrapopliteal Arterial Occlusive Diseases</brief_title>
  <official_title>A Prospective Study: the Value of Using Parametric Color Coding of Digital Subtraction Angiography and Flat-panel Detector Computed Tomography Parenchymal Blood Volume Imaging in the Endovascular Treatment of Infrapopliteal Arterial Occlusive Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <brief_summary>
    <textblock>
      Color coded blood flow and blood perfusion techniques are applied to the endovascular&#xD;
      treatment of infrapopliteal arterial occlusion,to establish a method of quantitative&#xD;
      evaluation of blood flow and tissue perfusion,to improve the level of calculation of&#xD;
      condition and curative effect. So as to establish a new complete evaluation system of&#xD;
      infrapopliteal arterial occlusive disease, to guide clinical further. At the same time&#xD;
      establish a digital information platform for clinical, lay the foundation for the large&#xD;
      research.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>patency rate</measure>
    <time_frame>1 year</time_frame>
    <description>We compare the change of blood flow velocity and blood perfusion volume before and after the recanalization of infrapopliteal arteries to assess the initial patency rate. While we test the ankle brachial index and toe brachial index at 3 , 6, 12 months, lower extremity arterial ultrasound at 6 mouths and computed tomographic angiography in 1 year to evaluate the patency of one year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>wound healing rate</measure>
    <time_frame>1 year</time_frame>
    <description>This is to evaluate the prognosis of patients who with the foot ulcer.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Arterial Occlusive Diseases</condition>
  <arm_group>
    <arm_group_label>pre-con</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>dyna-pbv</intervention_name>
    <arm_group_label>pre-con</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        These new technologies are performed in the treatment of patients older than 40 years. They&#xD;
        present with rest pain, intermittent claudication, ulceration or gangrenous. Some of them&#xD;
        have the risk factors of CLI, as hypertension, diabetes, hyperlipidemia or smoking. They&#xD;
        are referred to our vascular service for CLI-infrapopliteal artery occlusion. Computed&#xD;
        tomographic angiography discloses the occlusive lesion in anteriortibial, posterior tibial&#xD;
        or peroneal arteries.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients are diagnosed as lower limb atherosclerosis occlusion from June 2016 to June&#xD;
             2018 in our centre;&#xD;
&#xD;
          2. All participating patients provided written informed consent and willing to&#xD;
             participate;&#xD;
&#xD;
          3. aged 40 years and more;&#xD;
&#xD;
          4. the class of lower ischemia is upon 4;&#xD;
&#xD;
          5. below-the-knee arteries stenosis or occlusion is indicated by duplex or computed&#xD;
             tomographic angiography;&#xD;
&#xD;
          6. there is no heavy stenosis in superficial femoral artery (stenosis&lt;30%), or short&#xD;
             length lesion(length≤5cm, stenosis≥30%);&#xD;
&#xD;
          7. infection or ulceration don't happen in the area of surgery;&#xD;
&#xD;
          8. below the inguinal ligament arteries don't have the history of bypass or&#xD;
             interventional surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. disagree and refuse to the free therapy;&#xD;
&#xD;
          2. lesion length of superior artery is more than 5cm;&#xD;
&#xD;
          3. history of heart dysfunction: congestive heart failure,, myocardial infarction, severe&#xD;
             arrhythmia;&#xD;
&#xD;
          4. With severe metabolic disease, renal impairment(serum creatinine&gt;1.4mg/dL, glomerular&#xD;
             filtration rate&lt;60) affect the excretion of contrast agents;&#xD;
&#xD;
          5. have the diseases or agents which will reduce the viable of data;&#xD;
&#xD;
          6. allergy to iodinated contrast medium.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bao Liu, Ph.D</last_name>
    <phone>+86-010-69152502</phone>
    <email>liubao72@aliyun.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yupei Zhao, Ph.D</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>May 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>August 11, 2017</last_update_submitted>
  <last_update_submitted_qc>August 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2017</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>Arterial Occlusive Diseases</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/NCT03248323
org study id: A03968
nct id: NCT03248323
lead sponsor: 
Color coded blood flow and blood perfusion techniques are applied to the endovascular
      treatment of infrapopliteal arterial occlusion,to establish a method of quantitative
      evaluation of blood flow and tissue perfusion,to improve the level of calculation of
      condition and curative effect. So as to establish a new complete evaluation system of
      infrapopliteal arterial occlusive disease, to guide clinical further. At the same time
      establish a digital information platform for clinical, lay the foundation for the large
      research.
observational model: Case-Only
time perspective: Prospective
measure: patency rate
time frame: 1 year
description: We compare the change of blood flow velocity and blood perfusion volume before and after the recanalization of infrapopliteal arteries to assess the initial patency rate. While we test the ankle brachial index and toe brachial index at 3 , 6, 12 months, lower extremity arterial ultrasound at 6 mouths and computed tomographic angiography in 1 year to evaluate the patency of one year.
measure: wound healing rate
time frame: 1 year
description: This is to evaluate the prognosis of patients who with the foot ulcer.
arm group label: pre-con
intervention type: Radiation
intervention name: dyna-pbv
arm group label: pre-con
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Bao Liu, Ph.D
phone: +86-010-69152502
email: liubao72@aliyun.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Arterial Occlusive Diseases