<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/NCT04402372</url>
  </required_header>
  <id_info>
    <org_study_id>2020-1994</org_study_id>
    <nct_id>NCT04402372</nct_id>
  </id_info>
  <brief_title>Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery</brief_title>
  <official_title>Comparative Clinical Efficacy of Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara City Hospital Bilkent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara City Hospital Bilkent</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 aim of this study is to evaluate the safety and efficacy of the novel bidirectional&#xD;
      cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion&#xD;
      compared to conventional cannula with downstream line in patients undergoing femoral arterial&#xD;
      cannulation for cardiopulmonary bypass during minimally invasive surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The femoral artery is a common site for peripheral cannulation in patients requiring&#xD;
      cardiopulmonary bypass (CPB) for minimally invasive cardiac surgical procedures (MICS), redo&#xD;
      cardiac surgical procedures, and procedures involving the thoracic aorta Limb ischemia is the&#xD;
      most common acute and late vascular complication and has been reported in 10% to 70% of&#xD;
      patients Traditional methods to maintain distal perfusion include the use of a downstream&#xD;
      cannula or sewing on a side graft, but these techniques are cumbersome, time-consuming, and&#xD;
      require additional equipment As a result, current practice is relying on the very small&#xD;
      volume of blood that will flow around the cannula and collateral circulation to keep the leg&#xD;
      viable, but by the time ischemia is clinically evident, irreversible cell damage may have&#xD;
      already occurred The aim of this study is to evaluate the safety and efficacy of the novel&#xD;
      bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable&#xD;
      distal perfusion compared to conventional cannula with downstream line in patients undergoing&#xD;
      femoral arterial cannulation for CPB during MICS&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">June 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2020</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Vascular complications</measure>
    <time_frame>one moth</time_frame>
    <description>infection, emboli, hematoma, bleeding</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Efficacy and Safety of Novel Bidirectional Cannula</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>30 patients undergoing aortic valve replacement with minimally invasive technique prospectively randomized to receive 19 F bidirectional (BiflowTM, LivaNova, Italy) for femoral artery cannulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>30 patients undergoing aortic valve replacement with minimally invasive technique prospectively randomized to receive 19 F conventional (HLS, Maquet, Germany cannula with downstream line (6F) for femoral artery cannulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Novel bidirectional cannula (BiflowTM, LivaNova, Italy)</intervention_name>
    <description>We are going to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for CPB during minimally invasive surgery</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing elective minimally invasive aortic valve replacement&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient undergoing minimally invasvie aortic valve replacement 50-90 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous vascular surgery of the femoral artery, emergency cardiac surgery including&#xD;
             type A aortic dissections, internal diameter of the common femoral artery less than&#xD;
             7.5 mm and where the clinician felt adequate flow rates and line pressures would not&#xD;
             be achievable with a 19F cannula, because of the patient's weight and body surface&#xD;
             area&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Serdar Gunaydin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ankara City Hospital Bilkent</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Serdar Gunaydin, MD</last_name>
    <phone>905363896521</phone>
    <email>serdarkvc@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ankara City Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kanat Ozisik, MD</last_name>
      <phone>90-5052901885</phone>
      <email>sozisik2002@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Marasco SF, Tutungi E, Vallance SA, Udy AA, Negri JC, Zimmet AD, McGiffin DC, Pellegrino VA, Moshinsky RA. A Phase 1 Study of a Novel Bidirectional Perfusion Cannula in Patients Undergoing Femoral Cannulation for Cardiac Surgery. Innovations (Phila). 2018 Mar/Apr;13(2):97-103. doi: 10.1097/IMI.0000000000000489.</citation>
    <PMID>29697598</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara City Hospital Bilkent</investigator_affiliation>
    <investigator_full_name>Serdar Günaydın</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>cannula</keyword>
  <keyword>cardiopulmonary bypass</keyword>
  <keyword>bidirectional</keyword>
  <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/NCT04402372
org study id: 2020-1994
nct id: NCT04402372
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the safety and efficacy of the novel bidirectional
      cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion
      compared to conventional cannula with downstream line in patients undergoing femoral arterial
      cannulation for cardiopulmonary bypass during minimally invasive surgery
The femoral artery is a common site for peripheral cannulation in patients requiring
      cardiopulmonary bypass (CPB) for minimally invasive cardiac surgical procedures (MICS), redo
      cardiac surgical procedures, and procedures involving the thoracic aorta Limb ischemia is the
      most common acute and late vascular complication and has been reported in 10% to 70% of
      patients Traditional methods to maintain distal perfusion include the use of a downstream
      cannula or sewing on a side graft, but these techniques are cumbersome, time-consuming, and
      require additional equipment As a result, current practice is relying on the very small
      volume of blood that will flow around the cannula and collateral circulation to keep the leg
      viable, but by the time ischemia is clinically evident, irreversible cell damage may have
      already occurred The aim of this study is to evaluate the safety and efficacy of the novel
      bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable
      distal perfusion compared to conventional cannula with downstream line in patients undergoing
      femoral arterial cannulation for CPB during MICS
observational model: Cohort
time perspective: Prospective
measure: Vascular complications
time frame: one moth
description: infection, emboli, hematoma, bleeding
arm group label: Group 1
description: 30 patients undergoing aortic valve replacement with minimally invasive technique prospectively randomized to receive 19 F bidirectional (BiflowTM, LivaNova, Italy) for femoral artery cannulation
arm group label: Group 2
description: 30 patients undergoing aortic valve replacement with minimally invasive technique prospectively randomized to receive 19 F conventional (HLS, Maquet, Germany cannula with downstream line (6F) for femoral artery cannulation
intervention type: Device
intervention name: Novel bidirectional cannula (BiflowTM, LivaNova, Italy)
description: We are going to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for CPB during minimally invasive surgery
arm group label: Group 1
arm group label: Group 2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
last name: Serdar Gunaydin, MD
role: Principal Investigator
affiliation: Ankara City Hospital Bilkent
last name: Serdar Gunaydin, MD
phone: 905363896521
email: serdarkvc@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
citation: Marasco SF, Tutungi E, Vallance SA, Udy AA, Negri JC, Zimmet AD, McGiffin DC, Pellegrino VA, Moshinsky RA. A Phase 1 Study of a Novel Bidirectional Perfusion Cannula in Patients Undergoing Femoral Cannulation for Cardiac Surgery. Innovations (Phila). 2018 Mar/Apr;13(2):97-103. doi: 10.1097/IMI.0000000000000489.
PMID: 29697598
responsible party type: Principal Investigator
investigator affiliation: Ankara City Hospital Bilkent
investigator full name: Serdar Günaydın
investigator title: Professor
sharing ipd: No