<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/NCT03023475</url>
  </required_header>
  <id_info>
    <org_study_id>VesselHarvestingLigaSure</org_study_id>
    <nct_id>NCT03023475</nct_id>
  </id_info>
  <brief_title>Comparison of Two Different Endoscopic Radial Artery Harvesting Devices</brief_title>
  <official_title>Prospective Randomized Comparison of Two Different Endoscopic Radial Artery Harvesting Devices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kerckhoff Klinik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kerckhoff Klinik</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>
      Endoscopic radial artery harvesting in coronary bypass surgery is routinely performed by the&#xD;
      investigators. In this study, the investigators want to compare the MiFusion TLS2 (Endotrust&#xD;
      GmbH, Germany) device to the LigaSure Maryland Jaw (Medtronic, USA). The vessel harvesting is&#xD;
      performed in the standard fashion according to the institutional routine. The patients are&#xD;
      randomized preoperatively to one of the devices. The proximal end of the radial artery will&#xD;
      be preserved and deep-frozen for histological assessment. Endothelial integrity will be&#xD;
      investigated using Hematoxylin-Eosin, CD31 and endothelial nitrogen monoxide synthase.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endothelial integrity of the radial artery using histological examination.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Harvesting time</measure>
    <time_frame>The harvesting time will be measured during the vessel harvesting surgery.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemostasis in the arm indicated by bleeding from radial artery side branches or veins in the arm.</measure>
    <time_frame>Intraoperatively and directly after vessel harvesting the arm is controlled using the endoscope and bleeding can be detected during this control. End of surgery is end of this outcome parameter.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of vessel sealing, if side branches of the radial artery are bleeding after blood insufflation, additional clips have to placed at the side branch.</measure>
    <time_frame>The blood insufflation is performed immediately after vessel harvesting and leaks can be detected.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>CABG Graft Integrity</condition>
  <arm_group>
    <arm_group_label>LigaSure endoscopic radial harvesting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The endoscopic vessel harvesting will be performed using the LigaSure device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TLS2 endoscopic radial harvesting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The endoscopic vessel harvesting will be performed using the TLS2 device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LigaSure endoscopic vessel harvesting</intervention_name>
    <description>The radial artery will be harvested endoscopically using the LigaSure system.</description>
    <arm_group_label>LigaSure endoscopic radial harvesting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TLS2 endoscopic vessel harvesting</intervention_name>
    <description>The radial artery will be harvested endoscopically using the TLS2 system.</description>
    <arm_group_label>TLS2 endoscopic radial harvesting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all adult patients undergoing CABG using the radial artery&#xD;
&#xD;
          -  capability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no specific exclusion criteria&#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>Arnaud Van Linden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kerckhoff Klinik</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kerckhoff Klinik</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>February 22, 2020</last_update_submitted>
  <last_update_submitted_qc>February 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03023475
org study id: VesselHarvestingLigaSure
nct id: NCT03023475
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endoscopic radial artery harvesting in coronary bypass surgery is routinely performed by the
      investigators. In this study, the investigators want to compare the MiFusion TLS2 (Endotrust
      GmbH, Germany) device to the LigaSure Maryland Jaw (Medtronic, USA). The vessel harvesting is
      performed in the standard fashion according to the institutional routine. The patients are
      randomized preoperatively to one of the devices. The proximal end of the radial artery will
      be preserved and deep-frozen for histological assessment. Endothelial integrity will be
      investigated using Hematoxylin-Eosin, CD31 and endothelial nitrogen monoxide synthase.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Endothelial integrity of the radial artery using histological examination.
time frame: Through study completion, an average of 1 year.
measure: Harvesting time
time frame: The harvesting time will be measured during the vessel harvesting surgery.
measure: Hemostasis in the arm indicated by bleeding from radial artery side branches or veins in the arm.
time frame: Intraoperatively and directly after vessel harvesting the arm is controlled using the endoscope and bleeding can be detected during this control. End of surgery is end of this outcome parameter.
measure: Accuracy of vessel sealing, if side branches of the radial artery are bleeding after blood insufflation, additional clips have to placed at the side branch.
time frame: The blood insufflation is performed immediately after vessel harvesting and leaks can be detected.
arm group label: LigaSure endoscopic radial harvesting
arm group type: Active Comparator
description: The endoscopic vessel harvesting will be performed using the LigaSure device.
arm group label: TLS2 endoscopic radial harvesting
arm group type: Active Comparator
description: The endoscopic vessel harvesting will be performed using the TLS2 device.
intervention type: Device
intervention name: LigaSure endoscopic vessel harvesting
description: The radial artery will be harvested endoscopically using the LigaSure system.
arm group label: LigaSure endoscopic radial harvesting
intervention type: Device
intervention name: TLS2 endoscopic vessel harvesting
description: The radial artery will be harvested endoscopically using the TLS2 system.
arm group label: TLS2 endoscopic radial harvesting
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arnaud Van Linden, MD
role: Principal Investigator
affiliation: Kerckhoff Klinik
facility: 
country: Germany
responsible party type: Sponsor
sharing ipd: No