<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/NCT04459208</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0191</org_study_id>
    <nct_id>NCT04459208</nct_id>
  </id_info>
  <brief_title>Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation</brief_title>
  <acronym>CHOICE-CLOSURE</acronym>
  <official_title>Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helios Health Institute GmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helios Health Institute GmbH</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 the study is to evaluate the clinical efficacy of 2 different vascular closure&#xD;
      device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI).&#xD;
      The study hypothesizes that the choice of one over the other VCD in patients undergoing&#xD;
      transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural&#xD;
      complications and effectiveness of vascular closure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a&#xD;
      suture-based VCD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2020</start_date>
  <completion_date type="Actual">August 4, 2021</completion_date>
  <primary_completion_date type="Actual">July 7, 2021</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>
    <intervention_model_description>Investigator-initiated, single-center, prospective, open-label randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of access-site or access-related vascular injury</measure>
    <time_frame>30 days</time_frame>
    <description>Rate of access-site or access-related vascular injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of major access-site or access-related vascular injury</measure>
    <time_frame>up to 7 days and at 30 days</time_frame>
    <description>Rate of major access-site or access-related vascular injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of minor access site or access-related vascular injury</measure>
    <time_frame>up to 7 days and at 30 days</time_frame>
    <description>Rate of minor access site or access-related vascular injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria</measure>
    <time_frame>up to 7 days and at 30 days)</time_frame>
    <description>Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>all-cause death</measure>
    <time_frame>up to 7 days and 30-day</time_frame>
    <description>all-cause death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>death attributed to access-site or access-related complications</measure>
    <time_frame>up to 7 days and 30-day</time_frame>
    <description>death attributed to access-site or access-related complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>access-site or access-related disabling/life- threatening bleeding according to BARC</measure>
    <time_frame>up to 7 days and 30-day</time_frame>
    <description>access-site or access-related disabling/life- threatening bleeding according to BARC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>access-site or access-related major bleeding according to BARC</measure>
    <time_frame>up to 7 days and 30-day</time_frame>
    <description>access-site or access-related major bleeding according to BARC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>access-site or access-related minor bleeding according to BARC</measure>
    <time_frame>up to 7 days and 30-day</time_frame>
    <description>access-site or access-related minor bleeding according to BARC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for blood transfusion for access-site or access-related bleeding or vascular complications</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Need for blood transfusion for access-site or access-related bleeding or vascular complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of blood transfusions because of access-site or access-related bleeding</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Total number of blood transfusions because of access-site or access-related bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis</measure>
    <time_frame>24 hours</time_frame>
    <description>Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment</measure>
    <time_frame>24 hours</time_frame>
    <description>Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of postprocedural hospital stay</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Length of postprocedural hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to hemostasis, defined as the time from VCD application to complete hemostasis</measure>
    <time_frame>24 hours</time_frame>
    <description>Time to hemostasis, defined as the time from VCD application to complete hemostasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need and number of additional unplanned VCDs</measure>
    <time_frame>24 hours</time_frame>
    <description>Need and number of additional unplanned VCDs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent diameter stenosis of vascular access vessel on post-procedural angiography</measure>
    <time_frame>24 hours</time_frame>
    <description>Percent diameter stenosis of vascular access vessel on post-procedural angiography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">516</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>Manta</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>plug-based vascular closure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ProGlide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>suture-based vascular closure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Manta</intervention_name>
    <description>plug-based vascular closure</description>
    <arm_group_label>Manta</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ProGlide</intervention_name>
    <description>suture-based vascular closure</description>
    <arm_group_label>ProGlide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with an indication for transfemoral TAVI as judged by the local heart team.&#xD;
&#xD;
          2. Transfemoral access route and a commercially-available transcatheter aortic valve is&#xD;
             selected by the local heart team.&#xD;
&#xD;
          3. The patient is willing to provide written informed consent and comply with protocol-&#xD;
             specified follow-up evaluations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Vascular access site anatomy not suitable for percutaneous vascular closure.&#xD;
&#xD;
          2. Vascular access site complications prior to the TAVI procedure.&#xD;
&#xD;
          3. Known allergy or hypersensitivity to any VCD component.&#xD;
&#xD;
          4. Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia.&#xD;
&#xD;
          5. Absence of computed tomographic data of the access site before the procedure.&#xD;
&#xD;
          6. Systemic infection or a local infection at or near the access site.&#xD;
&#xD;
          7. Life expectancy of less than 6 months due to non-cardiac conditions.&#xD;
&#xD;
          8. Patient cannot adhere to or complete the investigational protocol for any reason.&#xD;
&#xD;
          9. Pregnant or nursing subjects.&#xD;
&#xD;
         10. Participation in any other interventional trial.&#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>Mohamed Abdel-Wahab, PD Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Herzzentrum Leipzig GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Herzzentrum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vascular access site closure</keyword>
  <keyword>Transcatheter aortic valve implantation</keyword>
  <keyword>Vascular closure device</keyword>
  <keyword>Vascular access-site injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</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/NCT04459208
org study id: 2020-0191
nct id: NCT04459208
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure
      device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI).
      The study hypothesizes that the choice of one over the other VCD in patients undergoing
      transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural
      complications and effectiveness of vascular closure.
Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a
      suture-based VCD.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Investigator-initiated, single-center, prospective, open-label randomized controlled trial
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
time frame: up to 7 days
description: Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
measure: Rate of access-site or access-related vascular injury
time frame: 30 days
description: Rate of access-site or access-related vascular injury
measure: Rate of major access-site or access-related vascular injury
time frame: up to 7 days and at 30 days
description: Rate of major access-site or access-related vascular injury
measure: Rate of minor access site or access-related vascular injury
time frame: up to 7 days and at 30 days
description: Rate of minor access site or access-related vascular injury
measure: Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
time frame: up to 7 days and at 30 days)
description: Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
measure: all-cause death
time frame: up to 7 days and 30-day
description: all-cause death
measure: death attributed to access-site or access-related complications
time frame: up to 7 days and 30-day
description: death attributed to access-site or access-related complications
measure: Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site
time frame: up to 7 days
description: Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other
measure: access-site or access-related disabling/life- threatening bleeding according to BARC
time frame: up to 7 days and 30-day
description: access-site or access-related disabling/life- threatening bleeding according to BARC
measure: access-site or access-related major bleeding according to BARC
time frame: up to 7 days and 30-day
description: access-site or access-related major bleeding according to BARC
measure: access-site or access-related minor bleeding according to BARC
time frame: up to 7 days and 30-day
description: access-site or access-related minor bleeding according to BARC
measure: Need for blood transfusion for access-site or access-related bleeding or vascular complications
time frame: up to 7 days
description: Need for blood transfusion for access-site or access-related bleeding or vascular complications
measure: Total number of blood transfusions because of access-site or access-related bleeding
time frame: up to 7 days
description: Total number of blood transfusions because of access-site or access-related bleeding
measure: Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
time frame: 24 hours
description: Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
measure: Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
time frame: 24 hours
description: Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
measure: Length of postprocedural hospital stay
time frame: up to 7 days
description: Length of postprocedural hospital stay
measure: Time to hemostasis, defined as the time from VCD application to complete hemostasis
time frame: 24 hours
description: Time to hemostasis, defined as the time from VCD application to complete hemostasis
measure: Need and number of additional unplanned VCDs
time frame: 24 hours
description: Need and number of additional unplanned VCDs
measure: Percent diameter stenosis of vascular access vessel on post-procedural angiography
time frame: 24 hours
description: Percent diameter stenosis of vascular access vessel on post-procedural angiography
arm group label: Manta
arm group type: Active Comparator
description: plug-based vascular closure
arm group label: ProGlide
arm group type: Active Comparator
description: suture-based vascular closure
intervention type: Device
intervention name: Manta
description: plug-based vascular closure
arm group label: Manta
intervention type: Device
intervention name: ProGlide
description: suture-based vascular closure
arm group label: ProGlide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohamed Abdel-Wahab, PD Dr.
role: Principal Investigator
affiliation: Herzzentrum Leipzig GmbH
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis