<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/NCT04428177</url>
  </required_header>
  <id_info>
    <org_study_id>06/RVO-FNOs/2020</org_study_id>
    <nct_id>NCT04428177</nct_id>
  </id_info>
  <brief_title>Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions</brief_title>
  <acronym>CCS</acronym>
  <official_title>Intravascular Lithotripsy in the Treatment of Calcified Coronary Lesions - Coronary Calcification Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Ostrava</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Ostrava</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>
      The aim of this prospective randomised study is to compare the safety and efficacy of novel&#xD;
      intravascular lithotripsy (IVL) to the standard therapy of calcified coronary lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include a total of 40 patients with calcified coronary lesions who will be&#xD;
      randomised 1:1 to the treatment with IVL (Shockwave; Shockwave Medical, Inc, Santa Clara,&#xD;
      USA) or the standard therapy (non-compliat high-pressure or Scoreflex predilatation,&#xD;
      rotational atherectomy, etc). Appropriate preparation of the lesions will be followed by DES&#xD;
      implantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>Minimal lumen diamether (MLD)</measure>
    <time_frame>1 year</time_frame>
    <description>minimal diamether of treated lesion measured by quantitative coronary angiography</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Late luemn loss (LLL)</measure>
    <time_frame>1 year</time_frame>
    <description>difference between post-procedure MLD and 12-month MLD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Binary in-stent restenosis</measure>
    <time_frame>1 year</time_frame>
    <description>diamether stenosis ≥ 50% of reference vessel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac events (MACE)</measure>
    <time_frame>1 year</time_frame>
    <description>Cardiac death, myocardial infarction or tagret lesion revascularisation (TVR)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Angiographic success</measure>
    <time_frame>up to end of the procedure, an average of 2 hours</time_frame>
    <description>success in facilitating stent delivery with &lt;50% residual stenosis and without serious angiographic complications</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical success</measure>
    <time_frame>up to discharge, an average of 3 days</time_frame>
    <description>angiographic success with no evidence of in-hospital MACE</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Coronary Artery Calcification</condition>
  <arm_group>
    <arm_group_label>Intrvascular Lithotripsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Calcified coronary lesions will be treated with intrvascular lithotripsy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard treatment of calcified coronary lesions: cutting, scoring or non-compliant balloon predilatation or rotational atherectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intravascular lithotripsy</intervention_name>
    <description>Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel</description>
    <arm_group_label>Intrvascular Lithotripsy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standart therapy</intervention_name>
    <description>conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy</description>
    <arm_group_label>Standard therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Informed, written consent by the patient&#xD;
&#xD;
          -  Ability to comply fully with the study protocol&#xD;
&#xD;
          -  Negative pregnancy test (and effective contraception) in women with childbearing&#xD;
             potential&#xD;
&#xD;
        Angiographic inclusion criteria:&#xD;
&#xD;
          -  Native coronary artery lesion with diameter stenosis ≥50% suitable for PCI&#xD;
&#xD;
          -  Heavy calcification, defined as calcification within the lesion on both sides of the&#xD;
             vessel assessed during angiography&#xD;
&#xD;
          -  Reference vessel diameter (RVD) ≥2.5 mm with lesion length &lt;32 mm&#xD;
&#xD;
          -  TIMI flow 3 of the target vessel at baseline&#xD;
&#xD;
          -  No visible thrombus at target lesion site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiogenic shock or haemodynamic instability requiring mechanical circulatory support&#xD;
&#xD;
          -  Active malignancy or other comorbidities with a life expectancy of 12 months&#xD;
&#xD;
          -  Limited the possibility of control coronaro angiography (e.g., advanced renal failure)&#xD;
&#xD;
          -  Known allergy to contrast agents (that cannot be adequately premedicated) or required&#xD;
             concomitant dual antiplatelet therapy&#xD;
&#xD;
          -  Current problems with substance abuse (e.g., alcohol or drugs)&#xD;
&#xD;
          -  Subject is participating in another investigational drug or device clinical study&#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_contact>
    <last_name>Leos Pleva, MD,PhD.</last_name>
    <phone>+420733414740</phone>
    <email>leos.pleva@volny.cz</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Cardiovascular Diseases, University Hospital</name>
      <address>
        <city>Ostrava</city>
        <state>Česká Republika</state>
        <zip>70852</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leos Pleva, MD, PhD</last_name>
      <phone>733414740</phone>
      <email>leos.pleva@volny.cz</email>
    </contact>
    <investigator>
      <last_name>Leos Pleva, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pavel Kukla, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Artery Calcification</keyword>
  <keyword>Intravascular Lithotripsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcinosis</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/NCT04428177
org study id: 06/RVO-FNOs/2020
nct id: NCT04428177
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this prospective randomised study is to compare the safety and efficacy of novel
      intravascular lithotripsy (IVL) to the standard therapy of calcified coronary lesions.
The study will include a total of 40 patients with calcified coronary lesions who will be
      randomised 1:1 to the treatment with IVL (Shockwave; Shockwave Medical, Inc, Santa Clara,
      USA) or the standard therapy (non-compliat high-pressure or Scoreflex predilatation,
      rotational atherectomy, etc). Appropriate preparation of the lesions will be followed by DES
      implantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Minimal lumen diamether (MLD)
time frame: 1 year
description: minimal diamether of treated lesion measured by quantitative coronary angiography
measure: Late luemn loss (LLL)
time frame: 1 year
description: difference between post-procedure MLD and 12-month MLD
measure: Binary in-stent restenosis
time frame: 1 year
description: diamether stenosis ≥ 50% of reference vessel
measure: Major adverse cardiac events (MACE)
time frame: 1 year
description: Cardiac death, myocardial infarction or tagret lesion revascularisation (TVR)
measure: Angiographic success
time frame: up to end of the procedure, an average of 2 hours
description: success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications
measure: Clinical success
time frame: up to discharge, an average of 3 days
description: angiographic success with no evidence of in-hospital MACE
arm group label: Intrvascular Lithotripsy
arm group type: Experimental
description: Calcified coronary lesions will be treated with intrvascular lithotripsy
arm group label: Standard therapy
arm group type: Active Comparator
description: Standard treatment of calcified coronary lesions: cutting, scoring or non-compliant balloon predilatation or rotational atherectomy
intervention type: Device
intervention name: Intravascular lithotripsy
description: Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel
arm group label: Intrvascular Lithotripsy
intervention type: Device
intervention name: Standart therapy
description: conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy
arm group label: Standard therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Leos Pleva, MD,PhD.
phone: +420733414740
email: leos.pleva@volny.cz
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Czechia
responsible party type: Sponsor
mesh term: Calcinosis
sharing ipd: No