<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/NCT04420715</url>
  </required_header>
  <id_info>
    <org_study_id>2018YFB1107102</org_study_id>
    <nct_id>NCT04420715</nct_id>
  </id_info>
  <brief_title>3D Printed Silicone Coronary Artery Simulator for Percutaneous Coronary Interventional Training</brief_title>
  <acronym>3DforPCI</acronym>
  <official_title>3D Printed Silicone Coronary Artery Simulator for Percutaneous Coronary Interventional Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China National Center for Cardiovascular Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China National Center for Cardiovascular Diseases</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>
      This study is aim to evaluate the feasibility and effectiveness of 3D printed silicone&#xD;
      coronary artery simulator for percutaneous coronary interventional training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the aging of the population, the incidence of cardiovascular diseases has exceeded that&#xD;
      of respiratory diseases and cancer, corresponding to the rapid increase in the number of&#xD;
      coronary stent implantation. Therefore, the standardized training of interventional&#xD;
      cardiologists is particularly important. Nowadays percutaneous coronary intervention (PCI)&#xD;
      training mode is mainly for the trainees to operate on the patients under the experienced&#xD;
      operator. Although this kind of training method can truly show the operation process, it has&#xD;
      obvious limitations. For beginners, it takes repeated training and revision to achieve&#xD;
      proficiency and accuracy.Learning only through real surgery may result in longer operative&#xD;
      times, increased radiation exposure, and increased complications.This study is aim to&#xD;
      evaluate the feasibility and effectiveness of 3D printed silicone coronary artery simulator&#xD;
      for percutaneous coronary interventional training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 7, 2020</start_date>
  <completion_date type="Anticipated">June 10, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 7, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the time taken in operation</measure>
    <time_frame>Through study completion, an average of 4 hours</time_frame>
    <description>The change of time taken to complete the coronary angiography assessment before and after training</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of the amount of contrast agent used</measure>
    <time_frame>Through study completion, an average of 4 hours</time_frame>
    <description>The change of the amount of contrast agent used in the coronary angiography assessment before and after training</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in assessment scores</measure>
    <time_frame>Through study completion, an average of 4 hours</time_frame>
    <description>The change of scores of &quot;Rating scale of coronary angiography operation assessment&quot; before and after training. The assessment includes operation integrity, standardization, proficiency, accuracy,etc. Every point contain 5 different levels from the worst(1) to the best(5).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Percutaneous Coronary Intervention</condition>
  <arm_group>
    <arm_group_label>Less-experienced group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participant who has completed the number of PCI less than 200 before recruiting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experienced group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participant who has completed the number of PCI more than 200 before recruiting</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training on coronary angiography using 3D coronary artery simulator</intervention_name>
    <description>Participants will have a test of coronary arteriography before and after training, compare the scores to analysis if the simulator training is effective.</description>
    <arm_group_label>Experienced group</arm_group_label>
    <arm_group_label>Less-experienced group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previous experience in coronary intervention&#xD;
&#xD;
          -  Understand the process of trail and be willing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No previous experience with coronary intervention&#xD;
&#xD;
          -  Unwilling to participate the trail&#xD;
&#xD;
          -  Unable to complete the trail due to other problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shubin Qiao, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fuwai Hospital, Beijing, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shubin Qiao, MD,PhD</last_name>
    <phone>+8613701237893</phone>
    <email>qsbfw@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhuoxuan Yang, MD,PhD</last_name>
    <phone>+8618811756722</phone>
    <email>525599492@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fuwai Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fu Wai Hospital, Beijing, China</investigator_affiliation>
    <investigator_full_name>Shubin_Qiao</investigator_full_name>
    <investigator_title>Director,Head of cardiology department</investigator_title>
  </responsible_party>
  <keyword>percutaneous coronary intervention</keyword>
  <keyword>3D printing</keyword>
  <keyword>silicone</keyword>
  <keyword>coronary artery simulator</keyword>
  <keyword>training</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>including the simulator details; the basic information of all participants; the scores of all participants before and after training; the training process</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>6 months after the trail completed</ipd_time_frame>
  </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/NCT04420715
org study id: 2018YFB1107102
nct id: NCT04420715
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is aim to evaluate the feasibility and effectiveness of 3D printed silicone
      coronary artery simulator for percutaneous coronary interventional training.
With the aging of the population, the incidence of cardiovascular diseases has exceeded that
      of respiratory diseases and cancer, corresponding to the rapid increase in the number of
      coronary stent implantation. Therefore, the standardized training of interventional
      cardiologists is particularly important. Nowadays percutaneous coronary intervention (PCI)
      training mode is mainly for the trainees to operate on the patients under the experienced
      operator. Although this kind of training method can truly show the operation process, it has
      obvious limitations. For beginners, it takes repeated training and revision to achieve
      proficiency and accuracy.Learning only through real surgery may result in longer operative
      times, increased radiation exposure, and increased complications.This study is aim to
      evaluate the feasibility and effectiveness of 3D printed silicone coronary artery simulator
      for percutaneous coronary interventional training.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change of the time taken in operation
time frame: Through study completion, an average of 4 hours
description: The change of time taken to complete the coronary angiography assessment before and after training
measure: Change of the amount of contrast agent used
time frame: Through study completion, an average of 4 hours
description: The change of the amount of contrast agent used in the coronary angiography assessment before and after training
measure: Change in assessment scores
time frame: Through study completion, an average of 4 hours
description: The change of scores of "Rating scale of coronary angiography operation assessment" before and after training. The assessment includes operation integrity, standardization, proficiency, accuracy,etc. Every point contain 5 different levels from the worst(1) to the best(5).
arm group label: Less-experienced group
arm group type: Experimental
description: The participant who has completed the number of PCI less than 200 before recruiting
arm group label: Experienced group
arm group type: Experimental
description: The participant who has completed the number of PCI more than 200 before recruiting
intervention type: Other
intervention name: Training on coronary angiography using 3D coronary artery simulator
description: Participants will have a test of coronary arteriography before and after training, compare the scores to analysis if the simulator training is effective.
arm group label: Experienced group
arm group label: Less-experienced group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shubin Qiao, MD,PhD
role: Principal Investigator
affiliation: Fuwai Hospital, Beijing, China
last name: Shubin Qiao, MD,PhD
phone: +8613701237893
email: qsbfw@sina.com
last name: Zhuoxuan Yang, MD,PhD
phone: +8618811756722
email: 525599492@qq.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fu Wai Hospital, Beijing, China
investigator full name: Shubin_Qiao
investigator title: Director,Head of cardiology department
sharing ipd: Yes
ipd description: including the simulator details; the basic information of all participants; the scores of all participants before and after training; the training process
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 6 months after the trail completed