<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/NCT03044002</url>
  </required_header>
  <id_info>
    <org_study_id>C1602</org_study_id>
    <nct_id>NCT03044002</nct_id>
  </id_info>
  <brief_title>BIOTRONIK 4French for AMBulatory Peripheral Intervention</brief_title>
  <acronym>BIO4AMB</acronym>
  <official_title>BIOTRONIK 4French for AMBulatory Peripheral Intervention. A Multicenter, Controlled Trial Comparing 4French Versus 6French Femoral Access for Endovascular Treatment of Lower-extremity Peripheral Artery Disease in an Ambulatory Setting: BIO4AMB</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biotronik AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biotronik AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      BIOTRONIK 4French for AMBulatory peripheral intervention. A multicenter, controlled trial&#xD;
      comparing 4French versus 6French femoral access for endovascular treatment of lower-extremity&#xD;
      peripheral artery disease in an ambulatory setting: BIO4AMB&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Controlled, multicenter, non-inferiority trial to compare the rate of access site&#xD;
      complications (ASC) in 4French (4F) vs. 6French (6F) femoral access endovascular&#xD;
      interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 17, 2017</start_date>
  <completion_date type="Actual">October 20, 2020</completion_date>
  <primary_completion_date type="Actual">October 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Peri- and post-procedural access site complications (including homeostasis strategy failure; post-procedural defined as within 30 days post-intervention)</measure>
    <time_frame>up to 30 days post procedure</time_frame>
    <description>Access site complications are defined as a composite of:&#xD;
Groin hematoma (larger than 5 cm in diameter, visible by sonography, and hemoglobin decrease &lt;3 g/dL)&#xD;
Pseudoaneurysm&#xD;
Groin as well as retroperitoneal bleeding (defined as requiring acute intervention for haemostasis, need for blood transfusions, or haemoglobin decrease &gt;3 g/dL)&#xD;
AV fistula (visible by shunting in colour coded sonography between the common femoral artery and vein)&#xD;
Arterial dissections at access site (visible with fluoroscopy or sonography as a membrane causing stenosis in the vessel lumen)&#xD;
Thrombosis&#xD;
VCD related ASCs</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">821</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <condition>Access Site Complication</condition>
  <condition>Outpatient Treatment</condition>
  <arm_group>
    <arm_group_label>4French Intervention</arm_group_label>
    <description>Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6French Intervention</arm_group_label>
    <description>Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biotronik 4 French Portfolio</intervention_name>
    <description>Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease</description>
    <arm_group_label>4French Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>6 French Portfolio</intervention_name>
    <description>Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease</description>
    <arm_group_label>6French Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular&#xD;
        treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years or minimum age as required by local regulations&#xD;
&#xD;
          -  Ability to walk&#xD;
&#xD;
          -  Subject must be willing to sign patient Informed Consent (PIC)&#xD;
&#xD;
          -  Patient with infrainguinal arteries lesion(s) suitable to be treated during an&#xD;
             ambulatory endovascular intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No possibility of an ambulatory management&#xD;
&#xD;
          -  Physical fitness classified as ASA ≥ 4 (American Society of Anaesthesiologists)&#xD;
&#xD;
          -  Coagulation disorders&#xD;
&#xD;
          -  Acute ischemia&#xD;
&#xD;
          -  Less than 1month live expectancy&#xD;
&#xD;
          -  Pregnant or breast feeding females or females who intend to become pregnant during the&#xD;
             time of the study (pregnancy test required for all women with child bearing potential)&#xD;
&#xD;
          -  Subject currently enrolled in other medical or drug study and has not reached the&#xD;
             primary outcome measures&#xD;
&#xD;
          -  Patient contraindicated for antiplatelet therapy, anticoagulants and antithrombotics&#xD;
&#xD;
          -  Other access than common femoral&#xD;
&#xD;
          -  Home alone the first night&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>PD Dott. med. Jos van den Berg</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ospedale Regionale di Lugano - Sezione Civico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>a.o. Univ. Prof. Dr. Marianne Brodmann</last_name>
    <role>Principal Investigator</role>
    <affiliation>Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medizinische Universitaet Graz</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.Z.Sint-Blasius</name>
      <address>
        <city>Dendermonde</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU du Bocage</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint Joseph</name>
      <address>
        <city>Trélazé</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osepedale Regionale di Lugano</name>
      <address>
        <city>Lugano</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>March 31, 2021</last_update_submitted>
  <last_update_submitted_qc>March 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03044002
org study id: C1602
nct id: NCT03044002
lead sponsor: 
has dmc: No
is fda regulated drug: No
BIOTRONIK 4French for AMBulatory peripheral intervention. A multicenter, controlled trial
      comparing 4French versus 6French femoral access for endovascular treatment of lower-extremity
      peripheral artery disease in an ambulatory setting: BIO4AMB
Controlled, multicenter, non-inferiority trial to compare the rate of access site
      complications (ASC) in 4French (4F) vs. 6French (6F) femoral access endovascular
      interventions.
observational model: Case-Control
time perspective: Prospective
measure: Peri- and post-procedural access site complications (including homeostasis strategy failure; post-procedural defined as within 30 days post-intervention)
time frame: up to 30 days post procedure
description: Access site complications are defined as a composite of:
Groin hematoma (larger than 5 cm in diameter, visible by sonography, and hemoglobin decrease <3 g/dL)
Pseudoaneurysm
Groin as well as retroperitoneal bleeding (defined as requiring acute intervention for haemostasis, need for blood transfusions, or haemoglobin decrease >3 g/dL)
AV fistula (visible by shunting in colour coded sonography between the common femoral artery and vein)
Arterial dissections at access site (visible with fluoroscopy or sonography as a membrane causing stenosis in the vessel lumen)
Thrombosis
VCD related ASCs
arm group label: 4French Intervention
description: Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment
arm group label: 6French Intervention
description: Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment
intervention type: Device
intervention name: Biotronik 4 French Portfolio
description: Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease
arm group label: 4French Intervention
intervention type: Device
intervention name: 6 French Portfolio
description: Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease
arm group label: 6French Intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: PD Dott. med. Jos van den Berg
role: Principal Investigator
affiliation: Ospedale Regionale di Lugano - Sezione Civico
last name: a.o. Univ. Prof. Dr. Marianne Brodmann
role: Principal Investigator
affiliation: Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Belgium
country: France
country: Switzerland
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease