<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/NCT03825094</url>
  </required_header>
  <id_info>
    <org_study_id>TP-6647</org_study_id>
    <nct_id>NCT03825094</nct_id>
  </id_info>
  <brief_title>DyeVert™ System for Contrast Monitoring in At-Risk Patients Undergoing Angiography: A Real-World Registry</brief_title>
  <acronym>DyeMINISH</acronym>
  <official_title>DyeVert™ System Use for Contrast Monitoring and Minimization in At-Risk Patients Undergoing Angiography Procedures: A Real-World Registry (DyeMINISH Registry)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Osprey Medical, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Osprey Medical, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this registry-based study is to evaluate the ongoing, real-world clinical&#xD;
      performance and safety of commercially available DyeVert Systems during typical clinical use&#xD;
      for patients undergoing coronary or peripheral angiography for diagnostic and/or&#xD;
      interventional procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Contrast-induced acute kidney injury (CI-AKI) occurs in 3-19% of patients undergoing coronary&#xD;
      angiography and is associated with increased morbidity, mortality, and healthcare costs.&#xD;
      Patients with chronic kidney disease have greater odds of developing CI-AKI. Guidelines for&#xD;
      CI-AKI prevention include screening for risk, volume expansion, and minimizing contrast media&#xD;
      volume (CMV) to the patient during angiography; however, hospitals face barriers to&#xD;
      implementation in the real-world setting and therefore consistent care delivery for at-risk&#xD;
      patients remains a modern clinical challenge. DyeVert Systems provide real-time CMV&#xD;
      monitoring and minimization during angiography procedures thereby reducing total CMV to the&#xD;
      patient and total CMV relative to baseline renal function, two known risk factors for CI-AKI.&#xD;
      The DyeMINISH Registry is designed to evaluate ongoing real-world clinical performance and&#xD;
      safety of commercially available DyeVert Systems among a large, real-world population of&#xD;
      patients undergoing coronary and peripheral angiography.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">May 7, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate contrast media volume (CMV) threshold setting practices and contrast media (CM) usage during index cath lab procedures in which the DyeVert System was used</measure>
    <time_frame>Index procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate incidence of adverse events associated with index cath lab procedures in which the DyeVert System was used</measure>
    <time_frame>Index procedure through 120 days post index procedure</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Patients at Risk for Developing Contrast-induced Nephropathy</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DyeVert™ Contrast Reduction Systems</intervention_name>
    <description>Osprey Medical DyeVert™ Contrast Reduction Systems (DyeVert Systems) provide fluid pathway resistance modulation such that excess contrast media (CM) (i.e. CM that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast media volume (CMV) reduction occurs, while maintaining adequate image quality.</description>
    <other_name>DyeVert Systems</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        DyeVert Systems are indicated for patients undergoing angiographic procedures requiring&#xD;
        injection of contrast media. Patients at risk for developing contrast-induced nephropathy&#xD;
        (CIN) represent the target population for these devices.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DyeVert Group Patients: Patient underwent a diagnostic and/or interventional&#xD;
             angiography procedure in which the DyeVert System was used in a majority of the case&#xD;
&#xD;
          -  Patient is willing and able to provide appropriate informed consent (if required)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Required data was not collected or is not available&#xD;
&#xD;
          -  In the Investigator or Sponsor's opinion, the patient is not considered to be suitable&#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>Anand Prasad, MD, FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Health Science Center San Antonio: Prof of Medicine &amp; Director Cardiac Catheterization Laboratory</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hartford Healthcare</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Steward Palmetto General Hospital</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Healthcare</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta VA Medical Center</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Heart &amp; Vascular Specialists</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Elizabeth Healthcare</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Mississippi Medical Center</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <zip>38801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRISTUS Health-Westover Hills</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Medical Center</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>April 14, 2022</last_update_submitted>
  <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2022</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>Kidney Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03825094
org study id: TP-6647
nct id: NCT03825094
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this registry-based study is to evaluate the ongoing, real-world clinical
      performance and safety of commercially available DyeVert Systems during typical clinical use
      for patients undergoing coronary or peripheral angiography for diagnostic and/or
      interventional procedures.
Contrast-induced acute kidney injury (CI-AKI) occurs in 3-19% of patients undergoing coronary
      angiography and is associated with increased morbidity, mortality, and healthcare costs.
      Patients with chronic kidney disease have greater odds of developing CI-AKI. Guidelines for
      CI-AKI prevention include screening for risk, volume expansion, and minimizing contrast media
      volume (CMV) to the patient during angiography; however, hospitals face barriers to
      implementation in the real-world setting and therefore consistent care delivery for at-risk
      patients remains a modern clinical challenge. DyeVert Systems provide real-time CMV
      monitoring and minimization during angiography procedures thereby reducing total CMV to the
      patient and total CMV relative to baseline renal function, two known risk factors for CI-AKI.
      The DyeMINISH Registry is designed to evaluate ongoing real-world clinical performance and
      safety of commercially available DyeVert Systems among a large, real-world population of
      patients undergoing coronary and peripheral angiography.
observational model: Cohort
time perspective: Retrospective
measure: Evaluate contrast media volume (CMV) threshold setting practices and contrast media (CM) usage during index cath lab procedures in which the DyeVert System was used
time frame: Index procedure
measure: Evaluate incidence of adverse events associated with index cath lab procedures in which the DyeVert System was used
time frame: Index procedure through 120 days post index procedure
intervention type: Device
intervention name: DyeVert™ Contrast Reduction Systems
description: Osprey Medical DyeVert™ Contrast Reduction Systems (DyeVert Systems) provide fluid pathway resistance modulation such that excess contrast media (CM) (i.e. CM that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast media volume (CMV) reduction occurs, while maintaining adequate image quality.
other name: DyeVert Systems
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anand Prasad, MD, FACC
role: Principal Investigator
affiliation: UT Health Science Center San Antonio: Prof of Medicine & Director Cardiac Catheterization Laboratory
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
sharing ipd: No