<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/NCT03016624</url>
  </required_header>
  <id_info>
    <org_study_id>S-20150133</org_study_id>
    <nct_id>NCT03016624</nct_id>
  </id_info>
  <brief_title>Coronary Artery Healing and Bioresorbable Scaffold</brief_title>
  <acronym>HONEST</acronym>
  <official_title>Coronary Artery Healing Process After BiOresorbable Scaffold iN PatiEnts With Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</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>
      To compare coronary healing after optical coherence tomography guided versus conventionally&#xD;
      angiography guided percutaneous coronary intervention with the Magmaris bioresorbable&#xD;
      scaffold.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND:&#xD;
&#xD;
      Bioresorbable scaffolds (BRS) represent a novel approach during percutaneous coronary&#xD;
      intervention (PCI), which provides transient vessel support with drug-delivery capability&#xD;
      without the long-term limitations (very late stent thrombosis) of the metallic drug-eluting&#xD;
      stents. Patients with Non-ST-segment elevation myocardial infarction (NSTEMI) often feature&#xD;
      thrombus-rich lesions with large necrotic core, which may be associated with delayed arterial&#xD;
      healing and impaired stent-related outcomes. Besides clinical indication and underlying&#xD;
      plaque morphology, sufficient and potent strut coverage depends on several additional factors&#xD;
      (patient characteristics, stent type and procedural factors). Particularly, acute incomplete&#xD;
      stent apposition is a strong procedural risk factor for later deficient neointimal coverage.&#xD;
      Optical coherence tomography (OCT) is a high-resolution intravascular imaging modality, that&#xD;
      enables in-vivo evaluation of the immediate stenting result, and the vascular healing pattern&#xD;
      including strut coverage at follow-up.&#xD;
&#xD;
      AIM:&#xD;
&#xD;
      The objective of this study is to investigate if OCT-guided Magmaris BRS implantation in&#xD;
      patients with NSTEMI can improve the coronary arterial healing at 6 months compared to&#xD;
      routine angiographic guidance only. Further to investigate if the plaque composition/lipid&#xD;
      content will influence on the vascular healing.&#xD;
&#xD;
      METHOD:&#xD;
&#xD;
      The study is designed as a prospective, randomized trial. After pre-dilation, patients will&#xD;
      be randomly assigned to either: (1) OCT-guided PCI, or (2) angio-guided PCI with Magmaris BRS&#xD;
      implantation. In the OCT-guided group, OCT will be used for vessel and BRS sizing. After&#xD;
      Magmaris BRS implantation the result will be controlled with OCT and: 1) BRS under expansion&#xD;
      and/or, 2) strut malapposition and/or, 3) edge dissection- and/or 4) residual stenosis at the&#xD;
      distal and/or proximal reference segment(s) that may require further intervention. A final&#xD;
      OCT will be performed in case of re-intervention.&#xD;
&#xD;
      In the angio-guided group an OCT will be performed only after angiography final and&#xD;
      acceptable result.&#xD;
&#xD;
      A follow-up OCT will be performed after 6 months in all patients to assess the vascular&#xD;
      healing and a vasomotor test will be performed in half of the patients. After 12 months the&#xD;
      dynamic changes in vascular healing will be assessed in the first enrolled half of the&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Actual">August 29, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Coronary artery healing score</measure>
    <time_frame>6 months</time_frame>
    <description>The primary endpoint is coronary artery healing score assessed by OCT Healing score is a weighted index that combines the following components: Uncovered scaffold struts, Uncovered &quot;jailed&quot; and acquired or persistent malapposed struts, Persistent mal apposition, Acquired mal apposition, Maximum neointimal growth and Accumulated extra stent lumen</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Coronary artery healing</measure>
    <time_frame>6 and 12 months.</time_frame>
    <description>Secondary endpoints are all individual components of coronary artery healing score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coronary artery healing</measure>
    <time_frame>6 months</time_frame>
    <description>Vasomotion at 6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>OCT guided Magmaris implantation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Percutaneous coronary intervention with Magmaris</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Angiography guided Magmaris implantation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Percutaneous coronary intervention with Magmaris</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OCT guided PCI</intervention_name>
    <description>oct guided</description>
    <arm_group_label>OCT guided Magmaris implantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Angiography guided PCI</intervention_name>
    <description>angio guided</description>
    <arm_group_label>Angiography guided Magmaris implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with NSTEMI undergoing subacute PCI in native vessels and to be treated with&#xD;
             one or more drug eluting stents in coronary arteries due to a visually assessed&#xD;
             significant culprit lesion with &gt; 50% of coronary stenosis at the catheterization&#xD;
             laboratory in Odense.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients participating in other randomized stent studies.&#xD;
&#xD;
          -  Expected survival &lt; 1 year.&#xD;
&#xD;
          -  Allergy to aspirin, ticagrelor, clopidogrel and prasugrel.&#xD;
&#xD;
          -  Allergy to Sirolimus.&#xD;
&#xD;
          -  Aorta-ostial lesions (cannot be cleared with flush by OCT).&#xD;
&#xD;
          -  Serum creatinine &gt; 150 ug/L due to the required amount of X-ray contrast by OCT.&#xD;
&#xD;
          -  Twisted coronary vessels where the PCI-operator estimates that the introduction of an&#xD;
             OCT and / or NIRS catheter will not be possible or will be associated with increased&#xD;
             risk.&#xD;
&#xD;
          -  Lesion length &gt; 28 mm.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisette O Jensen, MD, DMSci, PhD, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <state>Region Of Southern Denmark</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>February 28, 2021</last_update_submitted>
  <last_update_submitted_qc>February 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Christian Oliver Fallesen</investigator_full_name>
    <investigator_title>MD, PhD student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT03016624
org study id: S-20150133
nct id: NCT03016624
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To compare coronary healing after optical coherence tomography guided versus conventionally
      angiography guided percutaneous coronary intervention with the Magmaris bioresorbable
      scaffold.
BACKGROUND:

      Bioresorbable scaffolds (BRS) represent a novel approach during percutaneous coronary
      intervention (PCI), which provides transient vessel support with drug-delivery capability
      without the long-term limitations (very late stent thrombosis) of the metallic drug-eluting
      stents. Patients with Non-ST-segment elevation myocardial infarction (NSTEMI) often feature
      thrombus-rich lesions with large necrotic core, which may be associated with delayed arterial
      healing and impaired stent-related outcomes. Besides clinical indication and underlying
      plaque morphology, sufficient and potent strut coverage depends on several additional factors
      (patient characteristics, stent type and procedural factors). Particularly, acute incomplete
      stent apposition is a strong procedural risk factor for later deficient neointimal coverage.
      Optical coherence tomography (OCT) is a high-resolution intravascular imaging modality, that
      enables in-vivo evaluation of the immediate stenting result, and the vascular healing pattern
      including strut coverage at follow-up.

      AIM:

      The objective of this study is to investigate if OCT-guided Magmaris BRS implantation in
      patients with NSTEMI can improve the coronary arterial healing at 6 months compared to
      routine angiographic guidance only. Further to investigate if the plaque composition/lipid
      content will influence on the vascular healing.

      METHOD:

      The study is designed as a prospective, randomized trial. After pre-dilation, patients will
      be randomly assigned to either: (1) OCT-guided PCI, or (2) angio-guided PCI with Magmaris BRS
      implantation. In the OCT-guided group, OCT will be used for vessel and BRS sizing. After
      Magmaris BRS implantation the result will be controlled with OCT and: 1) BRS under expansion
      and/or, 2) strut malapposition and/or, 3) edge dissection- and/or 4) residual stenosis at the
      distal and/or proximal reference segment(s) that may require further intervention. A final
      OCT will be performed in case of re-intervention.

      In the angio-guided group an OCT will be performed only after angiography final and
      acceptable result.

      A follow-up OCT will be performed after 6 months in all patients to assess the vascular
      healing and a vasomotor test will be performed in half of the patients. After 12 months the
      dynamic changes in vascular healing will be assessed in the first enrolled half of the
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Coronary artery healing score
time frame: 6 months
description: The primary endpoint is coronary artery healing score assessed by OCT Healing score is a weighted index that combines the following components: Uncovered scaffold struts, Uncovered "jailed" and acquired or persistent malapposed struts, Persistent mal apposition, Acquired mal apposition, Maximum neointimal growth and Accumulated extra stent lumen
measure: Coronary artery healing
time frame: 6 and 12 months.
description: Secondary endpoints are all individual components of coronary artery healing score
measure: Coronary artery healing
time frame: 6 months
description: Vasomotion at 6 months
arm group label: OCT guided Magmaris implantation
arm group type: Active Comparator
description: Percutaneous coronary intervention with Magmaris
arm group label: Angiography guided Magmaris implantation
arm group type: Active Comparator
description: Percutaneous coronary intervention with Magmaris
intervention type: Device
intervention name: OCT guided PCI
description: oct guided
arm group label: OCT guided Magmaris implantation
intervention type: Device
intervention name: Angiography guided PCI
description: angio guided
arm group label: Angiography guided Magmaris implantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lisette O Jensen, MD, DMSci, PhD, Professor
role: Study Chair
affiliation: Odense University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Christian Oliver Fallesen
investigator title: MD, PhD student
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: Infarction