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/NCT05973994</url>
    </required_header>
    <id_info>
      <org_study_id>75/21</org_study_id>
      <nct_id>NCT05973994</nct_id>
    </id_info>
    <brief_title>Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT</brief_title>
    <acronym>SCALPO</acronym>
    <official_title>Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Rome Tor Vergata</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Rome Tor Vergata</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational, prospective, multicenter study is to explore local action of&#xD;
        coronary calcium fragmentation exerted by endovascular lithotripsy by images acquired with&#xD;
        OCT, in patients with coronary artery calcifications responsible for significant stenosis,&#xD;
        candidate to PCI. The main question it aims to answer, is the ability of Shockwave System to&#xD;
        reduce calcium density in the Region of Interest (ROI) of the vessel wall.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Coronary arteries with calcific lesions will undergo intravasculary lithotripsy (IVL)&#xD;
        treatment; OCT acquisition will be performed before IVL treatment, after IVL treatment and&#xD;
        after stent-implantation. All OCT frames will be uploaded on the image processing and&#xD;
        analysis program ImageJ (US National Institutes of Health). ROI will be selected as part of&#xD;
        image where calcium is located. Image analysis will be performed using frequency histogram of&#xD;
        pixel density in the ROI pre- and post-IVL, as a measure of calcium density. Mean pixel&#xD;
        density of the ROI before IVL will be compared with mean pixel density of the ROI after IVL,&#xD;
        measuring delta pixel density.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 21, 2022</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>Reduction of calcium density in the Region of Interest (ROI) of the vessel after lithotripsy treatment</measure>
      <time_frame>five-ten minutes</time_frame>
      <description>Calcium density is measured as delta pixel-density between calcific lesions images before and after lithotripsy at OCT acquisition</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reduction of stent malapposition after intracoronary lithotripsy application</measure>
      <time_frame>five minutes after stent impantation</time_frame>
      <description>Sten malapposition is measured as the distance between the abluminal surface of the strut and the luminal surface of the artery wall in the frames of lesion acquired by OCT after stent implantation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of acute vessel dissection and acute stent thrombosis or subacute vessel thrombosis after index procedure</measure>
      <time_frame>one, six months</time_frame>
      <description>Safety endpoint</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Coronary Artery Calcification</condition>
    <arm_group>
      <arm_group_label>Patients with significant calcific coronary artery stenosis candidate to PCI</arm_group_label>
      <description>Patients with coronary artery calcifications responsible for significant stenosis will undergo basal OCT acquistion. After intravascular lithotripsy (IVL) application, a second OCT acquisition will be made. The mean calcium density of the vessel's ROI before IVL and after IVL will be compared. Stent implantation will be performed after the second OCT acquisition.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>intravascular lithotripsy with Shockwave coronary system</intervention_name>
      <description>OCT acquistion is performed at baseline. Then the IVL catheter will be passed across the lesion over the guidewire. Atherectomy or cutting/scoring balloons is not permitted per protocol. The IVL procedure is considered successful when a residual stenosis &lt;50% by visual estimate after IVL alone is achieved. After IVL procedure, one OCT imaging acquisition must be performed. If the residual stenosis is ≥50% following IVL, noncompliant balloon dilatation will be performed prior to stenting and OCT images repeated accordingly. Subsequent stent implantation will be performed per local standard of care at the discretion of the operator. Following stent implantation, high pressure post-dilatation is recommended and OCT imaging acquisition must be performed to assess stent apposition for secondary end point.</description>
      <arm_group_label>Patients with significant calcific coronary artery stenosis candidate to PCI</arm_group_label>
      <other_name>OCT acquisition with FD-OCT imaging catheter</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients in the Catheterization Laboratory that undergo coronary angiography, are&#xD;
          potentially selected.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects with native coronary artery disease (including stable or unstable angina and&#xD;
               silent ischemia) suitable for PCI&#xD;
  &#xD;
            -  Left ventricular ejection fraction (LVEF) ≥35% as measured prior to enrollment&#xD;
  &#xD;
            -  eGFR ≥45 ml/min (Cockroft-Gault, MDRD)&#xD;
  &#xD;
            -  Troponin must be less than or equal to the upper limit of lab normal value within 24&#xD;
               hours prior to the procedure or if troponin is elevated, concomitant CK must be normal&#xD;
  &#xD;
            -  Ability to tolerate dual antiplatelet therapy (i.e. aspirin and clopidogrel,&#xD;
               prasugrel, or ticagrelor) for at least 6 months (for patient not on oral&#xD;
               anticoagulation) and single antiplatelet therapy for life&#xD;
  &#xD;
            -  The target lesion must be a de novo coronary lesion that has not been previously&#xD;
               treated with any interventional procedure&#xD;
  &#xD;
            -  Single de novo target lesion stenosis of LAD, RCA or LCX (or of their branches) with&#xD;
               stenosis of ≥70% and &lt;100% or stenosis ≥50% and &lt;70% (visually assessed) with evidence&#xD;
               of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR&#xD;
               &lt;0.89 or IVUS or OCT minimum lumen area ≤4.0 mm²&#xD;
  &#xD;
            -  Reference vessel must have 2.5 mm - 4.0 mm diameter and ≤ 30 mm length&#xD;
  &#xD;
            -  Evidence of calcification at the lesion site assessed by angiography, with&#xD;
               fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection&#xD;
               involving both sides of the arterial wall in at least one location and total length of&#xD;
               calcium of at least 15 mm and extending partially into the target lesion, or by IVUS&#xD;
               or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section&#xD;
  &#xD;
            -  Planned treatment of single lesion for every target vessel&#xD;
  &#xD;
            -  Ability to pass a 0.014&quot; guide wire across the lesion&#xD;
  &#xD;
            -  The target vessel must have a TIMI flow 3 at baseline&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Left ventricular ejection fraction (LVEF) &lt;35%&#xD;
  &#xD;
            -  Subject is pregnant or nursing&#xD;
  &#xD;
            -  eGFR &lt;45 ml/min (Cockroft-Gault, MDRD) or chronic dialysis&#xD;
  &#xD;
            -  Untreated pre-procedural haemoglobin &lt;9 g/dL or intention to refuse blood transfusions&#xD;
               if one should become necessary&#xD;
  &#xD;
            -  Patient has a platelet count &lt;100,000 cells/mm3 or &gt;750,000 cells/mm3&#xD;
  &#xD;
            -  Patient has a known allergy to protocol required medications (clopidogrel,&#xD;
               thienopyridines, aspirin, contrast media) that cannot be adequately premedicated&#xD;
  &#xD;
            -  Uncontrolled diabetes defined as a fasting hyperglycaemia &gt;200 mg/dL or HbA1c greater&#xD;
               than or equal to 10%&#xD;
  &#xD;
            -  Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA)&#xD;
               within the past 6 months, or has any permanent neurologic defect that may cause&#xD;
               non-compliance with the protocol&#xD;
  &#xD;
            -  Patient has an active peptic ulcer or active gastrointestinal (GI) bleeding&#xD;
  &#xD;
            -  Patient has a history of coagulopathy&#xD;
  &#xD;
            -  Subject is participating in another research study involving an investigational agent&#xD;
               (pharmaceutical, biologic, or medical device) that has not reached the primary&#xD;
               endpoint&#xD;
  &#xD;
            -  Subjects with a life expectancy of less than 1 year&#xD;
  &#xD;
            -  Subject refusing or not a candidate for emergency coronary artery bypass grafting&#xD;
               (CABG) surgery&#xD;
  &#xD;
            -  Planned use of atherectomy, scoring or cutting balloon, or any investigational device&#xD;
               other than lithotripsy&#xD;
  &#xD;
            -  Stent implantation in the target vessel within the last year or a stent within 10 mm&#xD;
               of the target lesion&#xD;
  &#xD;
            -  Definite or possible thrombus (by angiography or intravascular imaging) in the target&#xD;
               vessel&#xD;
  &#xD;
            -  Angiographic evidence of a dissection in the target vessel at baseline or after&#xD;
               guidewire passage&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Giuseppe M Sangiorgi, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Rome Tor Vergata</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Giuseppe M Sangiorgi, Professor</last_name>
      <phone>0620904009</phone>
      <email>gsangiorgi@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Rome Tor Vergata - Policlinico</name>
        <address>
          <city>Roma</city>
          <state>Rome</state>
          <zip>00133</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Giuseppe M Sangiorgi, Professor</last_name>
        <phone>0620904009</phone>
        <email>gsangiorgi@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Gianluca Massaro, Cardiologist</last_name>
        <email>gianluca88massaro@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
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    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Rome Tor Vergata</investigator_affiliation>
      <investigator_full_name>Prof. Giuseppe Sangiorgi</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Coronary artery calcification</keyword>
    <keyword>Intravascular Lithotripsy</keyword>
    <keyword>Optical Coherence Tomography</keyword>
    <keyword>Calcium density</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Calcinosis</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/NCT05973994
  org study id: 75/21
  nct id: NCT05973994
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  The goal of this observational, prospective, multicenter study is to explore local action of
        coronary calcium fragmentation exerted by endovascular lithotripsy by images acquired with
        OCT, in patients with coronary artery calcifications responsible for significant stenosis,
        candidate to PCI. The main question it aims to answer, is the ability of Shockwave System to
        reduce calcium density in the Region of Interest (ROI) of the vessel wall.
  Coronary arteries with calcific lesions will undergo intravasculary lithotripsy (IVL)
        treatment; OCT acquisition will be performed before IVL treatment, after IVL treatment and
        after stent-implantation. All OCT frames will be uploaded on the image processing and
        analysis program ImageJ (US National Institutes of Health). ROI will be selected as part of
        image where calcium is located. Image analysis will be performed using frequency histogram of
        pixel density in the ROI pre- and post-IVL, as a measure of calcium density. Mean pixel
        density of the ROI before IVL will be compared with mean pixel density of the ROI after IVL,
        measuring delta pixel density.
  observational model: Cohort
  time perspective: Prospective
  measure: Reduction of calcium density in the Region of Interest (ROI) of the vessel after lithotripsy treatment
  time frame: five-ten minutes
  description: Calcium density is measured as delta pixel-density between calcific lesions images before and after lithotripsy at OCT acquisition
  measure: Reduction of stent malapposition after intracoronary lithotripsy application
  time frame: five minutes after stent impantation
  description: Sten malapposition is measured as the distance between the abluminal surface of the strut and the luminal surface of the artery wall in the frames of lesion acquired by OCT after stent implantation.
  measure: Incidence of acute vessel dissection and acute stent thrombosis or subacute vessel thrombosis after index procedure
  time frame: one, six months
  description: Safety endpoint
  arm group label: Patients with significant calcific coronary artery stenosis candidate to PCI
  description: Patients with coronary artery calcifications responsible for significant stenosis will undergo basal OCT acquistion. After intravascular lithotripsy (IVL) application, a second OCT acquisition will be made. The mean calcium density of the vessel's ROI before IVL and after IVL will be compared. Stent implantation will be performed after the second OCT acquisition.
  intervention type: Device
  intervention name: intravascular lithotripsy with Shockwave coronary system
  description: OCT acquistion is performed at baseline. Then the IVL catheter will be passed across the lesion over the guidewire. Atherectomy or cutting/scoring balloons is not permitted per protocol. The IVL procedure is considered successful when a residual stenosis <50% by visual estimate after IVL alone is achieved. After IVL procedure, one OCT imaging acquisition must be performed. If the residual stenosis is ≥50% following IVL, noncompliant balloon dilatation will be performed prior to stenting and OCT images repeated accordingly. Subsequent stent implantation will be performed per local standard of care at the discretion of the operator. Following stent implantation, high pressure post-dilatation is recommended and OCT imaging acquisition must be performed to assess stent apposition for secondary end point.
  arm group label: Patients with significant calcific coronary artery stenosis candidate to PCI
  other name: OCT acquisition with FD-OCT imaging catheter
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Giuseppe M Sangiorgi, Professor
  role: Principal Investigator
  affiliation: University of Rome Tor Vergata
  last name: Giuseppe M Sangiorgi, Professor
  phone: 0620904009
  email: gsangiorgi@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Italy
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  PMID: 23266232
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  PMID: 23230101
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  responsible party type: Principal Investigator
  investigator affiliation: University of Rome Tor Vergata
  investigator full name: Prof. Giuseppe Sangiorgi
  investigator title: Professor
  mesh term: Calcinosis