<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/NCT03267056</url>
  </required_header>
  <id_info>
    <org_study_id>Acotec-04</org_study_id>
    <nct_id>NCT03267056</nct_id>
  </id_info>
  <brief_title>AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China</brief_title>
  <official_title>Real-World Registry Assessing the Clinical Use of the Orchid Drug Coated Balloon Catheter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acotec Scientific Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acotec Scientific Co., Ltd</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>
      The registry is a prospective, multicenter, single arm post-market real-world registry in&#xD;
      China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the&#xD;
      Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PTA is an established alternative to open surgical bypass for the treatment of infrainginual&#xD;
      disease of critical limb ischemia.&#xD;
&#xD;
      DEBs are designed to promote arterial patency by reducing neointimal proliferation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2018</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Primary patency of target lesion.</measure>
    <time_frame>12 months</time_frame>
    <description>The primary efficacy end point was primary patency at 12 months following the index procedure, defined as freedom from clinically driven target lesion revascularization and restenosis as determined by a duplex ultrasonography-derived peak systolic velocity ratio of&#xD;
≤2.4</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion</measure>
    <time_frame>6 months, 12 months</time_frame>
    <description>target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>improvment in Rutherford stage</measure>
    <time_frame>6 months, 12 months</time_frame>
    <description>improvementin Rutherford stage is defined as an upward shift of at least 1 category on Rutherford classification as compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in ankle brachial index(ABI)</measure>
    <time_frame>12 months</time_frame>
    <description>change in ankle brachial index(ABI) compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success during the operation</measure>
    <time_frame>during the operation</time_frame>
    <description>Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <arm_group>
    <arm_group_label>DCB arm</arm_group_label>
    <description>drug eluting balloon catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>drug eluting balloon catheter (trade name: Orchid)</intervention_name>
    <description>use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery</description>
    <arm_group_label>DCB arm</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with a more than 70% stenosis at femoral and/or popliteal artery meet all the&#xD;
        inclusion and excluison criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 80 years&#xD;
&#xD;
          -  Patients with peripheral artery disease (PAD), with Rutherford classification between&#xD;
             2 and 5&#xD;
&#xD;
          -  an occlusion or a minimum grade of stenosisPrimary over 70% in the superficial femoral&#xD;
             artery an /or the popliteal artery&#xD;
&#xD;
          -  Total length of treat lesion(s)is less or equal to 20cm&#xD;
&#xD;
          -  signed Patient informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  plasma Cr level greater than 150 umol/L in patients&#xD;
&#xD;
          -  patients with acute thrombosis requiring lysis or thrombectomy&#xD;
&#xD;
          -  2 or more than 2 stenosis lesions in traget vessel&#xD;
&#xD;
          -  patient with a lysis or an lower limb intervention as a therapy within the last 6&#xD;
             weeks&#xD;
&#xD;
          -  patient requiring intervention in both lower limbs at the same time&#xD;
&#xD;
          -  have &gt;30% residual stenosis or blood-limited dissection after predilation&#xD;
&#xD;
          -  distal outflow through less than one lower leg vessel&#xD;
&#xD;
          -  known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium,&#xD;
             etc.&#xD;
&#xD;
          -  patients participating in another clinical trials with interfere with this trial in&#xD;
             the past 3 months&#xD;
&#xD;
          -  pregnancy and lactating woman&#xD;
&#xD;
          -  untreatable bleeding diatheses&#xD;
&#xD;
          -  other diseases, such as cancer, liver disease, or cardiac insufficiency, which may&#xD;
             lead to protocol violations or markedly shorten a patients's life expectancy(less than&#xD;
             1 years)&#xD;
&#xD;
          -  patients unable or unwilling to participate this trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Guo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yinghua Zou</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The second hospital of hebei medical university</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The second affiliated hospital of Harbin medical university</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuhan central hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin First Center Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhejiang University</name>
      <address>
        <city>Nanjing</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 18, 2020</last_update_submitted>
  <last_update_submitted_qc>August 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>drug-coated balloon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03267056
org study id: Acotec-04
nct id: NCT03267056
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The registry is a prospective, multicenter, single arm post-market real-world registry in
      China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the
      Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
PTA is an established alternative to open surgical bypass for the treatment of infrainginual
      disease of critical limb ischemia.

      DEBs are designed to promote arterial patency by reducing neointimal proliferation.
observational model: Cohort
time perspective: Prospective
measure: Primary patency of target lesion.
time frame: 12 months
description: The primary efficacy end point was primary patency at 12 months following the index procedure, defined as freedom from clinically driven target lesion revascularization and restenosis as determined by a duplex ultrasonography-derived peak systolic velocity ratio of
≤2.4
measure: target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
time frame: 6 months, 12 months
description: target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
measure: improvment in Rutherford stage
time frame: 6 months, 12 months
description: improvementin Rutherford stage is defined as an upward shift of at least 1 category on Rutherford classification as compared to baseline
measure: change in ankle brachial index(ABI)
time frame: 12 months
description: change in ankle brachial index(ABI) compared to baseline
measure: Device success during the operation
time frame: during the operation
description: Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).
arm group label: DCB arm
description: drug eluting balloon catheter
intervention type: Device
intervention name: drug eluting balloon catheter (trade name: Orchid)
description: use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
arm group label: DCB arm
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wei Guo
role: Principal Investigator
affiliation: Chinese PLA General Hospital
last name: Yinghua Zou
role: Principal Investigator
affiliation: Peking University First Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease