<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/NCT03833323</url>
  </required_header>
  <id_info>
    <org_study_id>ISR PAS</org_study_id>
    <nct_id>NCT03833323</nct_id>
  </id_info>
  <brief_title>Implantable System for Remodulin Post-Approval Study</brief_title>
  <acronym>ISR PAS</acronym>
  <official_title>Implantable System for Remodulin Post-Approval Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Cardiac Rhythm and Heart Failure</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Medtronic Cardiac Rhythm and Heart Failure</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the Implantable System for Remodulin (ISR) Post Approval Study (PAS) is to&#xD;
      provide evaluation and periodic reporting of the safety and effectiveness of Medtronic&#xD;
      market-released ISR, including the catheter and the pump.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ISR PAS is an observational, prospective, non-randomized, multi-center study. It will&#xD;
      enroll a minimum of 50 newly implanted patients at up to 10 US sites, observing and reporting&#xD;
      catheter-related complications and pump failures through 5 years post implant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Implantable System for Remodulin not commercially approved.&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>Catheter-related complications</measure>
    <time_frame>Implant to 5 years post-implant</time_frame>
    <description>Number of adverse events requiring invasive intervention that are related to the ISR catheter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pump failures</measure>
    <time_frame>Implant to 5 years post-implant</time_frame>
    <description>Number of adverse events requiring invasive intervention that are related to the ISR pump.</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Pulmonary Arterial Hypertension</condition>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Implantable System for Remodulin (treprostinil)</intervention_name>
    <description>All patients will be implanted with the Implantable System for Remodulin (treprostinil).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Newly implanted patients that are intended to receive an ISR.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject or legally authorized representative provides written authorization and/or&#xD;
             consent per institution and geographical requirements.&#xD;
&#xD;
          -  Subject is intended to receive an eligible ISR product.&#xD;
&#xD;
          -  Subject is at least 22 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is pregnant.&#xD;
&#xD;
          -  Subject who is expected to be inaccessible for follow-up.&#xD;
&#xD;
          -  Subject with exclusion criteria required by local law.&#xD;
&#xD;
          -  Subject is currently enrolled in or plans to enroll in any concurrent drug and/or&#xD;
             device study that may confound results (i.e. no required intervention that could&#xD;
             affect interpretation of all-around product safety and or effectiveness).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Bourge, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>June 30, 2021</last_update_submitted>
  <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PAH</keyword>
  <keyword>Pulmonary Arterial Hypertension</keyword>
  <keyword>Pulmonary Hypertension</keyword>
  <keyword>Remodulin</keyword>
  <keyword>treprostinil</keyword>
  <keyword>DelIVery for PAH</keyword>
  <keyword>Implantable Pump</keyword>
  <keyword>Drug Pump</keyword>
  <keyword>Intrathecal Catheter</keyword>
  <keyword>Targeted Drug Delivery</keyword>
  <keyword>Programmable Pump</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Treprostinil</mesh_term>
  </intervention_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/NCT03833323
org study id: ISR PAS
nct id: NCT03833323
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: No
The purpose of the Implantable System for Remodulin (ISR) Post Approval Study (PAS) is to
      provide evaluation and periodic reporting of the safety and effectiveness of Medtronic
      market-released ISR, including the catheter and the pump.
The ISR PAS is an observational, prospective, non-randomized, multi-center study. It will
      enroll a minimum of 50 newly implanted patients at up to 10 US sites, observing and reporting
      catheter-related complications and pump failures through 5 years post implant.
observational model: Cohort
time perspective: Prospective
measure: Catheter-related complications
time frame: Implant to 5 years post-implant
description: Number of adverse events requiring invasive intervention that are related to the ISR catheter.
measure: Pump failures
time frame: Implant to 5 years post-implant
description: Number of adverse events requiring invasive intervention that are related to the ISR pump.
intervention type: Combination Product
intervention name: Implantable System for Remodulin (treprostinil)
description: All patients will be implanted with the Implantable System for Remodulin (treprostinil).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Bourge, MD
role: Study Chair
affiliation: University of Alabama at Birmingham
responsible party type: Sponsor
mesh term: Pulmonary Arterial Hypertension
mesh term: Hypertension
mesh term: Treprostinil