<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/NCT01694368</url>
  </required_header>
  <id_info>
    <org_study_id>2011-285</org_study_id>
    <nct_id>NCT01694368</nct_id>
  </id_info>
  <brief_title>Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques</brief_title>
  <acronym>NIRS-IVUS</acronym>
  <official_title>Multimodality Advanced Intracoronary Imaging With Near-infrared Spectroscopy and Intravascular Ultrasound to Characterize Coronary Artery Plaques Before and After Percutaneous Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spectrum Health Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spectrum Health Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To characterize atherosclerotic coronary artery plaques using advanced intra-coronary imaging&#xD;
      with a combined near-infrared spectroscopy and intravascular ultrasound catheter before and&#xD;
      after percutaneous intervention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is being performed to characterize the composition and morphologic characteristics&#xD;
      of atherosclerotic coronary artery plaques with intra-coronary near-infrared spectroscopy and&#xD;
      intravascular ultrasound in patients undergoing percutaneous coronary intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MACCE</measure>
    <time_frame>5 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Coronary Artery Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Coronary Artery Disease Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is at &gt; 18 years of age&#xD;
&#xD;
          2. Subject presents to the catheterization laboratory to undergo clinically-indicated,&#xD;
             invasive coronary angiography&#xD;
&#xD;
          3. Subject is willing and able to provide informed written consent&#xD;
&#xD;
          4. Subject is found to have ≥ 1 severe coronary artery stenosis by invasive angiography&#xD;
             and percutaneous coronary intervention is planned for definitive treatment or found to&#xD;
             have ≥ 1 intermediate coronary artery stenosis and IVUS planned for lesion assessment&#xD;
&#xD;
          5. Coronary anatomy is deemed suitable for combined NIRS-IVUS by the interventional&#xD;
             cardiologist performing invasive angiography and intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is pregnant or suspected to be pregnant&#xD;
&#xD;
          2. Subject is unable to provide informed consent&#xD;
&#xD;
          3. Subject has coronary artery anatomy deemed by interventionalist as unsuitable for&#xD;
             NIRS-IVUS&#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>Ryan D Madder, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spectrum Health Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spectrum Health; Frederik Meijer Heart &amp;Vascular Institute</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>July 6, 2023</last_update_submitted>
  <last_update_submitted_qc>July 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spectrum Health Hospitals</investigator_affiliation>
    <investigator_full_name>Ryan Madder, MD</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <keyword>Near infrared spectroscopy; lipid core; vulnerable plaque</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT01694368
org study id: 2011-285
nct id: NCT01694368
lead sponsor: 
has dmc: No
To characterize atherosclerotic coronary artery plaques using advanced intra-coronary imaging
      with a combined near-infrared spectroscopy and intravascular ultrasound catheter before and
      after percutaneous intervention
This study is being performed to characterize the composition and morphologic characteristics
      of atherosclerotic coronary artery plaques with intra-coronary near-infrared spectroscopy and
      intravascular ultrasound in patients undergoing percutaneous coronary intervention.
observational model: Other
time perspective: Prospective
measure: MACCE
time frame: 5 year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ryan D Madder, MD
role: Principal Investigator
affiliation: Spectrum Health Hospitals
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Spectrum Health Hospitals
investigator full name: Ryan Madder, MD
investigator title: Physician
mesh term: Coronary Artery Disease
sharing ipd: No