<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/NCT01682057</url>
  </required_header>
  <id_info>
    <org_study_id>RH-01</org_study_id>
    <nct_id>NCT01682057</nct_id>
  </id_info>
  <brief_title>A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension</brief_title>
  <official_title>A Prospective, Non-Randomized, Open Label, Multi-Center Study to Evaluate the ROX Anastomotic Coupler System (ACS) in Patients With Severe Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ROX Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ROX Medical, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic&#xD;
      Coupler System (ACS) in patients with severe hypertension.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in mean office SBP</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Change in mean office SBP at six months as compared to Baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mean office DBP</measure>
    <time_frame>Change in mean office DBP six months as compared to Baseline</time_frame>
    <description>Change in mean office DBP at six months as compared to Baseline</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ROX Anastomic Coupler System (ACS) + continuing standard antihypertensive medications</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ROX ANASTOMOTIC COUPLER SYSTEM (ACS)</intervention_name>
    <description>The ROX Anastomic Coupler (ACS) will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ROX Anastomotic Coupler System (ACS)</intervention_name>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of severe hypertension must be made on the basis of current findings,&#xD;
             medical history, and physical examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any serious medical condition that may adversely affect the patient's safety, limit&#xD;
             the subject's ability to participate in the study, comply with follow-up requirements&#xD;
             or impact the scientific integrity of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>January 27, 2015</last_update_submitted>
  <last_update_submitted_qc>January 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>High Blood Pressure</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Resistant Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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/NCT01682057
org study id: RH-01
nct id: NCT01682057
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic
      Coupler System (ACS) in patients with severe hypertension.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in mean office SBP
time frame: Baseline, 6 months
description: Change in mean office SBP at six months as compared to Baseline
measure: Change in mean office DBP
time frame: Change in mean office DBP six months as compared to Baseline
description: Change in mean office DBP at six months as compared to Baseline
arm group label: Group A
arm group type: Experimental
description: ROX Anastomic Coupler System (ACS) + continuing standard antihypertensive medications
intervention type: Device
intervention name: ROX ANASTOMOTIC COUPLER SYSTEM (ACS)
description: The ROX Anastomic Coupler (ACS) will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
arm group label: Group A
intervention type: Device
intervention name: ROX Anastomotic Coupler System (ACS)
arm group label: Group A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Hypertension