xml: <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/NCT06035783</url>
    </required_header>
    <id_info>
      <org_study_id>NL81318.078.22</org_study_id>
      <nct_id>NCT06035783</nct_id>
    </id_info>
    <brief_title>Calcium Reduction by Orbital Atherectomy in Western Europe</brief_title>
    <acronym>CROWN</acronym>
    <official_title>Calcium Reduction by Orbital Atherectomy in Western Europe</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erasmus Medical Center</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>
        In calcified lesions, optimal stent placement and expansion may prove to be challenging.&#xD;
        Lesion preparation is necessary to facilitate optimal stenting in calcified lesions, for&#xD;
        which orbital atherectomy can used. Therefore the aim of this study is to:&#xD;
  &#xD;
          1. Show that orbital atherectomy effectuates optimal stent expansion&#xD;
  &#xD;
          2. Investigate the mechanics of lesion preparation when using orbital atherectomy&#xD;
  &#xD;
        Patients presenting with a significant and severely calcified lesion in need of orbital&#xD;
        atherectomy will undergo optical coherence tomography guided orbital atherectomy and stent&#xD;
        placement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems Inc.,&#xD;
        St. Paul,MN,USA) is a percutaneous device indicated to modify calcified lesion in order to&#xD;
        facilitate stent delivery in patients with severely calcified coronary artery disease (CAD).&#xD;
        As of to date, detailed sequential intravascular imaging data unraveling the exact calcium&#xD;
        modifying effect of orbital atherectomy (OA) prior to stent placement in vivo, are lacking.&#xD;
  &#xD;
        The aim of this, international, multicenter, prospective and observational single arm study&#xD;
        is to understand the mechanism of action of OA for the treatment of de novo, severely&#xD;
        calcified coronary lesions priot to stent placement using optical coherence tomography (OCT)&#xD;
        and to assess stent expansion, based on OCT derived minimal stent area. The study population&#xD;
        consists of patients undergoing percutaneous coronary intervention of a severely calcified&#xD;
        coronary lesion in need of OA to enable proper stent placement and expansion.&#xD;
  &#xD;
        A total of 100 patients will be enrolled. All patients will undergo peri-procedural imaging&#xD;
        using OCT and the aim is to obtain data for at least 50 patients with OCT before and after OA&#xD;
        and after stenting.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">April 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2025</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>Primary imaging endpoint</measure>
      <time_frame>Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours</time_frame>
      <description>Proportion of patients that reach stent expansion ≥ 5.5mm² as assessed by OCT derived MSA</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Procedural success</measure>
      <time_frame>Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours</time_frame>
      <description>Procedural success is defined as successful stent delivery with:&#xD;
  Final core lab defined TIMI III flow&#xD;
  Angiographic in-stent DS ≤20%&#xD;
  absence of in-hospital major adverse cardiac and cerebrovascular events (consisting of all-cause death, spontaneous myocardial infarction, target vessel revascularization or stroke)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Target vessel failure (TVF)</measure>
      <time_frame>Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months</time_frame>
      <description>TVF is defined as a composite of cardiac death, target vessel spontaneous myocardial infarction and target vessel revascularization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Major adverse cardiac events (MACE)</measure>
      <time_frame>Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months</time_frame>
      <description>MACE is defined is a composite of all-cause death, spontaneous myocardial infarction and repeat revascularization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Individual components of MACE and TVF</measure>
      <time_frame>Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months</time_frame>
      <description>The components of MACE and TVF will be measured individually, namely:&#xD;
  All-cause death&#xD;
  Cardiac death&#xD;
  Spontaneous myocardial infarction&#xD;
  Target vessel spontaneous myocardial infarction&#xD;
  Target vessel revascularization&#xD;
  Repeat revascularization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Periprocedural myocardial infarction</measure>
      <time_frame>Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours</time_frame>
      <description>The incidence of periprocedural myocardial infarction, namely type 4a (4th universal definition of myocardial infarction)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Major intraprocedural complications</measure>
      <time_frame>Periprocedure</time_frame>
      <description>Major intraprocedural complications include type C-F dissections, perforations, slow flow or no reflow, thrombus and major side branch occlusion (&gt; 2mm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Probable and definite stent thrombosis</measure>
      <time_frame>Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MSA on OCT</measure>
      <time_frame>Periprocedure</time_frame>
      <description>Final MSA</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stent expansion on OCT</measure>
      <time_frame>Periprocedure</time_frame>
      <description>Percentage of stent expansion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intracoronary imaging endpoints on OCT</measure>
      <time_frame>Periprocedure</time_frame>
      <description>Minimal lumen area post orbital atherectomy and post stenting</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Calcium and fractures on OCT</measure>
      <time_frame>Periprocedure</time_frame>
      <description>Number of calcium fractures&#xD;
  Number of calcium factures based on calcium thickness post orbital atherectomy&#xD;
  Number of calcified nodules modified post orbital atherectomy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hematoma on OCT</measure>
      <time_frame>Periprocedure</time_frame>
      <description>Incidence of OCT defined hematomas post orbital atherectomy&#xD;
  Incidence and quantifications of dissections post orbital atherectomy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diameter stenosis on angiography</measure>
      <time_frame>Periprocedure</time_frame>
      <description>- In-stent and in-segment DS</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>minimal luminal diameter Diameter on angiography</measure>
      <time_frame>Periprocedure</time_frame>
      <description>- In-stent and in-segment MLD</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute gain Diameter on angiography</measure>
      <time_frame>Periprocedure</time_frame>
      <description>- In-stent and in-segment acute gain</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Vascular Calcification* / Diagnostic Imaging</condition>
    <condition>Atherectomies, Coronary</condition>
    <condition>Tomography, Optical Coherence</condition>
    <condition>Coronary Intervention, Percutaneous</condition>
    <condition>Coronary Angiography</condition>
    <condition>Humans</condition>
    <condition>Treatment Outcome</condition>
    <condition>Vascular Calcification* / Therapy</condition>
    <condition>Vascular Calcification</condition>
    <arm_group>
      <arm_group_label>Observational cohort</arm_group_label>
      <description>Patients undergoing PCI of a severely calcified coronary lesion in need of OA to enable proper stent placement</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Orbital Atherectomy</intervention_name>
      <description>The Diamondback 360° Coronary orbital atherectomy system (OAS) is a device dedicated to debulk severely calcified coronary lesions to facilitate stent delivery and enable stent expansion with optimal results. The OAS's main mechanism is the synergistic rotation of the crown around its axis and simultaneously its endoluminal orbital motion. This effect allows blood to flow continuously and it facilitates heat dispersion which results in reduced heat damage to the arterial walls and subsequently to less myocardial damage, at the same time it softens the plaques tissue. It also appears that the microparticles created from sanding the artery plaques do not create any agglomeration to the branching arteries</description>
      <arm_group_label>Observational cohort</arm_group_label>
      <other_name>DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing PCI of severely calcified coronary lesion in need of orbital&#xD;
          atherectomy to enable proper stent placement and expansion&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  De novo significant native coronary artery lesion&#xD;
  &#xD;
            -  The target lesion must have evidence of severe calcification: 1) presence of&#xD;
               radiopacities noted without cardiac motion prior to contrast injection involving both&#xD;
               sides of the arterial wall with calcification length of at least 15 mm and extend&#xD;
               partially into the target lesion. 2) OR presence of ≥ 270° of calcium or lumen&#xD;
               protruding calcified nodules at &gt;1 cross section by intravascular imaging (OCT)&#xD;
  &#xD;
            -  The target vessel reference diameter ≥ 2.5 mm and ≤ 4.0 mm and lesion must not exceed&#xD;
               40 mm in length&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Left main disease&#xD;
  &#xD;
            -  Prior stenting of the target vessel&#xD;
  &#xD;
            -  Target lesion has thrombus or dissection&#xD;
  &#xD;
            -  Known left ventricular ejection fraction LVEF ≤ 25%&#xD;
  &#xD;
            -  Diagnosed with chronic renal failure (GFR &lt; 30 ml/min)&#xD;
  &#xD;
            -  Confirmed pregnancy&#xD;
  &#xD;
            -  Life expectancy &lt; 12 months&#xD;
  &#xD;
            -  Coronary anatomy that prevents delivery of OCT catheter&#xD;
  &#xD;
            -  Known allergy to soybean oil, egg yolk phospholipids, glycerin or sodium hydroxide&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>Wijnand den Dekker</investigator_full_name>
      <investigator_title>Interventional Cardiologist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Calcinosis</mesh_term>
      <mesh_term>Vascular Calcification</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035783
  org study id: NL81318.078.22
  nct id: NCT06035783
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  In calcified lesions, optimal stent placement and expansion may prove to be challenging.
        Lesion preparation is necessary to facilitate optimal stenting in calcified lesions, for
        which orbital atherectomy can used. Therefore the aim of this study is to:
  
          1. Show that orbital atherectomy effectuates optimal stent expansion
  
          2. Investigate the mechanics of lesion preparation when using orbital atherectomy
  
        Patients presenting with a significant and severely calcified lesion in need of orbital
        atherectomy will undergo optical coherence tomography guided orbital atherectomy and stent
        placement.
  The Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems Inc.,
        St. Paul,MN,USA) is a percutaneous device indicated to modify calcified lesion in order to
        facilitate stent delivery in patients with severely calcified coronary artery disease (CAD).
        As of to date, detailed sequential intravascular imaging data unraveling the exact calcium
        modifying effect of orbital atherectomy (OA) prior to stent placement in vivo, are lacking.
  
        The aim of this, international, multicenter, prospective and observational single arm study
        is to understand the mechanism of action of OA for the treatment of de novo, severely
        calcified coronary lesions priot to stent placement using optical coherence tomography (OCT)
        and to assess stent expansion, based on OCT derived minimal stent area. The study population
        consists of patients undergoing percutaneous coronary intervention of a severely calcified
        coronary lesion in need of OA to enable proper stent placement and expansion.
  
        A total of 100 patients will be enrolled. All patients will undergo peri-procedural imaging
        using OCT and the aim is to obtain data for at least 50 patients with OCT before and after OA
        and after stenting.
  observational model: Cohort
  time perspective: Prospective
  measure: Primary imaging endpoint
  time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
  description: Proportion of patients that reach stent expansion ≥ 5.5mm² as assessed by OCT derived MSA
  measure: Procedural success
  time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
  description: Procedural success is defined as successful stent delivery with:
  Final core lab defined TIMI III flow
  Angiographic in-stent DS ≤20%
  absence of in-hospital major adverse cardiac and cerebrovascular events (consisting of all-cause death, spontaneous myocardial infarction, target vessel revascularization or stroke)
  measure: Target vessel failure (TVF)
  time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months
  description: TVF is defined as a composite of cardiac death, target vessel spontaneous myocardial infarction and target vessel revascularization.
  measure: Major adverse cardiac events (MACE)
  time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months
  description: MACE is defined is a composite of all-cause death, spontaneous myocardial infarction and repeat revascularization
  measure: Individual components of MACE and TVF
  time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months
  description: The components of MACE and TVF will be measured individually, namely:
  All-cause death
  Cardiac death
  Spontaneous myocardial infarction
  Target vessel spontaneous myocardial infarction
  Target vessel revascularization
  Repeat revascularization
  measure: Periprocedural myocardial infarction
  time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
  description: The incidence of periprocedural myocardial infarction, namely type 4a (4th universal definition of myocardial infarction)
  measure: Major intraprocedural complications
  time frame: Periprocedure
  description: Major intraprocedural complications include type C-F dissections, perforations, slow flow or no reflow, thrombus and major side branch occlusion (> 2mm)
  measure: Probable and definite stent thrombosis
  time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours, 30 days, 12 months
  measure: MSA on OCT
  time frame: Periprocedure
  description: Final MSA
  measure: Stent expansion on OCT
  time frame: Periprocedure
  description: Percentage of stent expansion
  measure: Intracoronary imaging endpoints on OCT
  time frame: Periprocedure
  description: Minimal lumen area post orbital atherectomy and post stenting
  measure: Calcium and fractures on OCT
  time frame: Periprocedure
  description: Number of calcium fractures
  Number of calcium factures based on calcium thickness post orbital atherectomy
  Number of calcified nodules modified post orbital atherectomy
  measure: Hematoma on OCT
  time frame: Periprocedure
  description: Incidence of OCT defined hematomas post orbital atherectomy
  Incidence and quantifications of dissections post orbital atherectomy
  measure: Diameter stenosis on angiography
  time frame: Periprocedure
  description: - In-stent and in-segment DS
  measure: minimal luminal diameter Diameter on angiography
  time frame: Periprocedure
  description: - In-stent and in-segment MLD
  measure: Acute gain Diameter on angiography
  time frame: Periprocedure
  description: - In-stent and in-segment acute gain
  arm group label: Observational cohort
  description: Patients undergoing PCI of a severely calcified coronary lesion in need of OA to enable proper stent placement
  intervention type: Device
  intervention name: Orbital Atherectomy
  description: The Diamondback 360° Coronary orbital atherectomy system (OAS) is a device dedicated to debulk severely calcified coronary lesions to facilitate stent delivery and enable stent expansion with optimal results. The OAS's main mechanism is the synergistic rotation of the crown around its axis and simultaneously its endoluminal orbital motion. This effect allows blood to flow continuously and it facilitates heat dispersion which results in reduced heat damage to the arterial walls and subsequently to less myocardial damage, at the same time it softens the plaques tissue. It also appears that the microparticles created from sanding the artery plaques do not create any agglomeration to the branching arteries
  arm group label: Observational cohort
  other name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: Wijnand den Dekker
  investigator title: Interventional Cardiologist
  mesh term: Calcinosis
  mesh term: Vascular Calcification