<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/NCT03287024</url>
  </required_header>
  <id_info>
    <org_study_id>BNT002BeGrow</org_study_id>
    <nct_id>NCT03287024</nct_id>
  </id_info>
  <brief_title>BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants</brief_title>
  <official_title>Prospective, Multicenter, Single-arm Study to Assess the Safety and Performance of the BeGrow Stent System in Newborns and Infants to Treat Pulmonary Artery Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bentley InnoMed GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LS medcap GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bentley InnoMed GmbH</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Objective of the study is to assess safety and performance of the BeGrow Stent System for&#xD;
      newborns and infants in pulmonary artery stenosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Bentley InnoMed &quot;BeGrow Stent System for Newborns and Infants&quot; is a stent delivery system&#xD;
      indicated for intraluminal placement in the pulmonary arteries of newborns and infants for&#xD;
      the treatment of Pulmonary Artery Stenosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">May 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective, multi-centre, explorative single-arm study This open-label, non-randomized multi-centre study uses an &quot;umbrella protocol&quot; (Part A and Part B) designed to collect data for performance and safety as well as long-term safety data from pulmonary artery stenosis patients who are treated with the BeGrow stent system to treat the stenosis&#xD;
Part A: Safety and Performance (Implantation and Re-dilatation) Part B: Safety on Long-Term Follow-up</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vessel enlargement in mm</measure>
    <time_frame>after procedure and during follow ups up to 12 Months</time_frame>
    <description>Vessel enlargement will be measured in mm, directly before and after stent implantation by angiography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of serious adverse events device and procedure related</measure>
    <time_frame>12 Months</time_frame>
    <description>Incidence of SAE</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Pulmonary Artery Stenosis</condition>
  <arm_group>
    <arm_group_label>BeGrow Stent System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All enrolled subjects will receive the BeGrow Stent System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BeGrow Stent System</intervention_name>
    <description>All enrolled subjects will undergo primary stenting of the target lesion by placement of the BeGrow Stent System</description>
    <arm_group_label>BeGrow Stent System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Single lesion(s) which can be treated with a 6 mm BeGrow stent (only one stent per&#xD;
             lesion allowed).&#xD;
&#xD;
          -  Pulmonary artery stenosis - patient must at least have one of the following diseases:&#xD;
&#xD;
               -  Haemodynamically relevant proximal or distal branch pulmonary artery stenosis&#xD;
                  with a reduction of the vessel diameter when the vessel/patient is large enough&#xD;
                  to accommodate a stent,&#xD;
&#xD;
               -  Haemodynamically relevant stenosis of the main pulmonary artery segment that&#xD;
                  results in elevation of the Right Ventricle (RV) pressure, provided that the&#xD;
                  stent definitely will not compromise a functioning pulmonary valve and will not&#xD;
                  impinge on the pulmonary artery bifurcation,&#xD;
&#xD;
               -  Any degree of stenosis in patients with single ventricle circulation&#xD;
&#xD;
               -  Critically ill postoperative cardiac patients when it has been determined that&#xD;
                  branch pulmonary artery stenosis is resulting in a definite haemodynamic&#xD;
                  compromise in a patient/vessel of any size, particularly if balloon dilatation is&#xD;
                  unsuccessful&#xD;
&#xD;
          -  Signed written informed consent (by parents/legal guardians)&#xD;
&#xD;
          -  Lesion can be accessed with a guide wire or balloon catheter&#xD;
&#xD;
          -  Age ≤ 24 months and weight ≥ 2 kg&#xD;
&#xD;
          -  Adequate stent length available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The following lesions are excluded from treatment with BeGrow stent:&#xD;
&#xD;
               -  Shunt stenosis&#xD;
&#xD;
               -  Valvular and subvalvular pulmonary stenosis&#xD;
&#xD;
          -  Patients with known hypersensitivity to the stent material (L605 cobalt-chromium).&#xD;
&#xD;
          -  Patients with clinical or biological signs of infection.&#xD;
&#xD;
          -  Patients with active endocarditis.&#xD;
&#xD;
          -  Patients with known allergy to acetylsalicylic acid, other antiplatelet agents or&#xD;
             heparin.&#xD;
&#xD;
          -  Presence of other previously implanted stents in the same lesion or in close proximity&#xD;
             to stent (direct stent-stent contact).&#xD;
&#xD;
          -  Patients with known coagulation disorder.&#xD;
&#xD;
          -  Patients where direct stent-stent contact or overlapping cannot be avoided.&#xD;
&#xD;
          -  Patients where contact to the vessel wall over the entire stent length cannot be&#xD;
             ensured after dilatation (especially in short and thick lesions).&#xD;
&#xD;
          -  Patients where the BeGrow stent could protrude freely into adjacent vessels after&#xD;
             expansion/dilatation, including the pulmonary arterial bifurcation.&#xD;
&#xD;
          -  Implantation of the BeGrow stent in the pulmonary arterial bifurcation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oliver Kretschmar, Prof.Dr.med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kinderspital Zürich, Pädiatrische Kardiologie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medizinische Universität Wien, AKH Wien, Abteilung für Pädiatrische Kardiologie</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Children's Hospital, Center for Pediatrics - Department of Cardiology</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäts-Kinderspital Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Serbia</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</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>Stenosis, Pulmonary Artery</mesh_term>
    <mesh_term>Constriction, Pathologic</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/NCT03287024
org study id: BNT002BeGrow
nct id: NCT03287024
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective of the study is to assess safety and performance of the BeGrow Stent System for
      newborns and infants in pulmonary artery stenosis.
The Bentley InnoMed "BeGrow Stent System for Newborns and Infants" is a stent delivery system
      indicated for intraluminal placement in the pulmonary arteries of newborns and infants for
      the treatment of Pulmonary Artery Stenosis.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, multi-centre, explorative single-arm study This open-label, non-randomized multi-centre study uses an "umbrella protocol" (Part A and Part B) designed to collect data for performance and safety as well as long-term safety data from pulmonary artery stenosis patients who are treated with the BeGrow stent system to treat the stenosis
Part A: Safety and Performance (Implantation and Re-dilatation) Part B: Safety on Long-Term Follow-up
primary purpose: Treatment
masking: None (Open Label)
measure: Vessel enlargement in mm
time frame: after procedure and during follow ups up to 12 Months
description: Vessel enlargement will be measured in mm, directly before and after stent implantation by angiography
measure: Incidence of serious adverse events device and procedure related
time frame: 12 Months
description: Incidence of SAE
arm group label: BeGrow Stent System
arm group type: Experimental
description: All enrolled subjects will receive the BeGrow Stent System
intervention type: Device
intervention name: BeGrow Stent System
description: All enrolled subjects will undergo primary stenting of the target lesion by placement of the BeGrow Stent System
arm group label: BeGrow Stent System
criteria: 
gender: All
minimum age: N/A
maximum age: 24 Months
healthy volunteers: No
last name: Oliver Kretschmar, Prof.Dr.med
role: Principal Investigator
affiliation: Kinderspital Zürich, Pädiatrische Kardiologie
facility: 
facility: 
facility: 
country: Austria
country: Serbia
country: Switzerland
responsible party type: Sponsor
mesh term: Stenosis, Pulmonary Artery
mesh term: Constriction, Pathologic