<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/NCT04434456</url>
  </required_header>
  <id_info>
    <org_study_id>C-HEAL</org_study_id>
    <nct_id>NCT04434456</nct_id>
  </id_info>
  <brief_title>Carotid Artery Aneurysm Treatment Using CGuard Divert-And-Heal Strategy</brief_title>
  <acronym>C-HEAL</acronym>
  <official_title>Prospective Observational Study of CGuard MicroNet Covered Stent System Use as a Flow Diverter in the Endovascular Exclusion of Carotid Artery Aneurysms. (CGuard Divert-and-HEAL C-HEAL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>John Paul II Hospital, Krakow</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>John Paul II Hospital, Krakow</source>
  <oversight_info>
    <has_dmc>No</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>
      Non-randomized, single arm, open label, academic observational study of CGuard MicroNet&#xD;
      covered stent system use to achieve endovascular lumen reconstruction in carotid artery&#xD;
      aneurysms with indications for treatment (enlarging and/or dissecting / symptomatic).&#xD;
&#xD;
      Jagiellonian University Medical College research project.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Carotid artery aneurysm (CAA) is a relatively infrequent, but significant clinical condition&#xD;
      with numerous diagnostic and therapeutic implications. CAA affects laminal flow in the&#xD;
      carotid artery implicating the risk of thrombus formation in the aneurysm cavity, and&#xD;
      subsequent ischemic stroke from distal embolization. Another important clinical problem&#xD;
      related to the CAA is a possible aneurysm dissection and rupture. Symptomatic CAA and&#xD;
      increasing dimensions of CAA institute unquestioned indications for the CAA treatment.&#xD;
&#xD;
      Surgical carotid aneurysm repair bears a significant risk (periprocedural stroke, cranial&#xD;
      nerve damage, carotid artery ligation). Therefore endovascular techniques of CAA exclusion&#xD;
      were developed. Covered stents, stent-grafts, and combined stenting and aneurysm embolization&#xD;
      with coils were applied. However, covered stents were demonstrated to increase the restenosis&#xD;
      risk, and other complications such as CAA neck endo-leak.&#xD;
&#xD;
      Newer technique involves the flow diversion by implantation of stent in dense-structured&#xD;
      stent (such as Wallstent) or stent-in-stent implantation. In this case a luminary flow&#xD;
      dominates over aneurysm filling, which is limited by stent structure. Gradual thrombosis and&#xD;
      occlusion of aneurysm cavity and healing of aneurysm follows.This method disadvantage was&#xD;
      related to necessity of double stent load and increased restenosis risk (double metal layer).&#xD;
&#xD;
      These issues were addressed only recently by the double layer mesh stents that demonstrate&#xD;
      natural flow diverting capabilities. CGuard Stent system is a self-expandable stent covered&#xD;
      with PET mesh (MicroNet) that prevents plaque protrusion into the vessel lumen. In addition,&#xD;
      in low flow conditions MicroNet can act as the flow diverter. These stents are routinely&#xD;
      implanted in elevated risk plaques in high reference centers in Europe.&#xD;
&#xD;
      Several published observations indicate the CGuard stent also demonstrates flow-diverting&#xD;
      capabilities, but the systematic observation of such application was not performed.&#xD;
&#xD;
      C-HEAL is a non-randomized, single arm, open label academic observational study of CGuard&#xD;
      stent implantation in carotid arteries in patients with symptomatic, dissecting or enlarging&#xD;
      carotid artery aneurysm. Procedures are performed according to the center routine, with&#xD;
      application of proximal or distal embolic protection device (if feasible), and standard&#xD;
      pharmacotherapy according to the current guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 27, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2022</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>Rate of successful aneurysm exclusion</measure>
    <time_frame>6 months</time_frame>
    <description>Successful aneurysm cavity exclusion and endovascular lumen reconstruction on routine, non-invasive CT angiography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of procedural success</measure>
    <time_frame>Peri-procedural</time_frame>
    <description>Procedural success defined as: Technical success (successful MicroNet covered stent delivery and implantation with complete aneurysm necks coverage) and Clinical success (no complications)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of In-hospital MACNE (major adverse cardiac and neurological events)</measure>
    <time_frame>48 hrs or until discharge</time_frame>
    <description>In-hospital MACNE (death, stroke, myocardial infarction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACNE at 30 days</measure>
    <time_frame>30 days</time_frame>
    <description>MACNE at 30 days (death, stroke, myocardial infarction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of peri-procedural complications</measure>
    <time_frame>48 hrs or until discharge</time_frame>
    <description>Any complications occurring up to 48 hours post procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of clinical efficacy at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Clinical efficacy defined as successful aneurysm exclusion and no procedure related complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of clinical efficacy at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Clinical efficacy defined as successful aneurysm exclusion and no procedure related complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the target vessel segment</measure>
    <time_frame>6 months</time_frame>
    <description>Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in ultrasound evaluation of target vessel segment (if amenable to duplex Doppler examination)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel segment</measure>
    <time_frame>12 months</time_frame>
    <description>Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in ultrasound evaluation of target vessel segment (if amenable to duplex Doppler examination)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel segment</measure>
    <time_frame>24 months</time_frame>
    <description>Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in ultrasound evaluation of target vessel segment (if amenable to duplex Doppler examination)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Carotid Artery Aneurysm</condition>
  <arm_group>
    <arm_group_label>CGuard stenting (interventional)</arm_group_label>
    <description>CGuard implantation in the carotid artery with aneurysm requiring intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CGuard stent implantation</intervention_name>
    <description>CGuard stent implantation in the carotid artery with symptomatic, dissecting or enlarging aneurysm</description>
    <arm_group_label>CGuard stenting (interventional)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        10 to 25 patients meeting inclusion and exclusion criteria and evaluated by Vascular Team&#xD;
        to receive an endovascular treatment for carotid artery aneurysm&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        General&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years, eligible for endovascular carotid artery aneurysm&#xD;
             treatment with Micronet covered stent per Vascular Team evaluation, according to local&#xD;
             standards&#xD;
&#xD;
          -  Written, informed consent to participate&#xD;
&#xD;
          -  Agreement to attend protocol required (standard) follow up visits and examinations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preferred treatment other than stenting (surgery or conservative treatment /&#xD;
             observation) per Vascular Team evaluation&#xD;
&#xD;
          -  Life expectancy &lt;1 year (e.g. active neoplastic disease).&#xD;
&#xD;
          -  Chronic kidney disease with creatinine &gt; 3.0 mg/dL.&#xD;
&#xD;
          -  Myocardial infarction in 72 hours proceeding the stenting procedure (if possible,&#xD;
             postponing the procedure)&#xD;
&#xD;
          -  Pregnancy (positive pregnancy test)&#xD;
&#xD;
          -  Coagulopathy.&#xD;
&#xD;
          -  History of uncontrolled contrast media intolerance&#xD;
&#xD;
        Angiographic&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Carotid artery aneurysm confirmed on angiography - symptomatic, dissected or enlarging&#xD;
&#xD;
          -  Aneurysm eligible for endovascular treatment per Vascular Team evaluation (according&#xD;
             to current standards, guidelines and study center practice)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unsuccessful true lumen engagement&#xD;
&#xD;
          -  Aneurysm neck anatomy precluding healthy-to-healthy coverage with stent&#xD;
&#xD;
          -  Anatomic variants precluding stent implantation&#xD;
&#xD;
          -  Mobile (free-floating) plaque elements in aorta or arteries proximal to target lesion&#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>Piotr Musialek, MD, DPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>The John Paul II Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Piotr Musialek, MD, DPhil</last_name>
    <phone>+48126142287</phone>
    <email>p.musialek@szpitaljp2.krakow.pl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Cardiac and Vascular Diseases, The John Paul II Hospital</name>
      <address>
        <city>Kraków</city>
        <state>Maloplska</state>
        <zip>31-202</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Piotr Musialek, Prof</last_name>
      <phone>+48126142287</phone>
      <email>p.musialek@szpitaljp2.krakow.pl</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</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/NCT04434456
org study id: C-HEAL
nct id: NCT04434456
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Non-randomized, single arm, open label, academic observational study of CGuard MicroNet
      covered stent system use to achieve endovascular lumen reconstruction in carotid artery
      aneurysms with indications for treatment (enlarging and/or dissecting / symptomatic).

      Jagiellonian University Medical College research project.
Carotid artery aneurysm (CAA) is a relatively infrequent, but significant clinical condition
      with numerous diagnostic and therapeutic implications. CAA affects laminal flow in the
      carotid artery implicating the risk of thrombus formation in the aneurysm cavity, and
      subsequent ischemic stroke from distal embolization. Another important clinical problem
      related to the CAA is a possible aneurysm dissection and rupture. Symptomatic CAA and
      increasing dimensions of CAA institute unquestioned indications for the CAA treatment.

      Surgical carotid aneurysm repair bears a significant risk (periprocedural stroke, cranial
      nerve damage, carotid artery ligation). Therefore endovascular techniques of CAA exclusion
      were developed. Covered stents, stent-grafts, and combined stenting and aneurysm embolization
      with coils were applied. However, covered stents were demonstrated to increase the restenosis
      risk, and other complications such as CAA neck endo-leak.

      Newer technique involves the flow diversion by implantation of stent in dense-structured
      stent (such as Wallstent) or stent-in-stent implantation. In this case a luminary flow
      dominates over aneurysm filling, which is limited by stent structure. Gradual thrombosis and
      occlusion of aneurysm cavity and healing of aneurysm follows.This method disadvantage was
      related to necessity of double stent load and increased restenosis risk (double metal layer).

      These issues were addressed only recently by the double layer mesh stents that demonstrate
      natural flow diverting capabilities. CGuard Stent system is a self-expandable stent covered
      with PET mesh (MicroNet) that prevents plaque protrusion into the vessel lumen. In addition,
      in low flow conditions MicroNet can act as the flow diverter. These stents are routinely
      implanted in elevated risk plaques in high reference centers in Europe.

      Several published observations indicate the CGuard stent also demonstrates flow-diverting
      capabilities, but the systematic observation of such application was not performed.

      C-HEAL is a non-randomized, single arm, open label academic observational study of CGuard
      stent implantation in carotid arteries in patients with symptomatic, dissecting or enlarging
      carotid artery aneurysm. Procedures are performed according to the center routine, with
      application of proximal or distal embolic protection device (if feasible), and standard
      pharmacotherapy according to the current guidelines.
observational model: Cohort
time perspective: Prospective
measure: Rate of successful aneurysm exclusion
time frame: 6 months
description: Successful aneurysm cavity exclusion and endovascular lumen reconstruction on routine, non-invasive CT angiography
measure: Rate of procedural success
time frame: Peri-procedural
description: Procedural success defined as: Technical success (successful MicroNet covered stent delivery and implantation with complete aneurysm necks coverage) and Clinical success (no complications)
measure: Rate of In-hospital MACNE (major adverse cardiac and neurological events)
time frame: 48 hrs or until discharge
description: In-hospital MACNE (death, stroke, myocardial infarction)
measure: MACNE at 30 days
time frame: 30 days
description: MACNE at 30 days (death, stroke, myocardial infarction)
measure: Number of peri-procedural complications
time frame: 48 hrs or until discharge
description: Any complications occurring up to 48 hours post procedure
measure: Rate of clinical efficacy at 6 months
time frame: 6 months
description: Clinical efficacy defined as successful aneurysm exclusion and no procedure related complications
measure: Rate of clinical efficacy at 12 months
time frame: 12 months
description: Clinical efficacy defined as successful aneurysm exclusion and no procedure related complications
measure: Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the target vessel segment
time frame: 6 months
description: Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in ultrasound evaluation of target vessel segment (if amenable to duplex Doppler examination)
measure: Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel segment
time frame: 12 months
description: Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in ultrasound evaluation of target vessel segment (if amenable to duplex Doppler examination)
measure: Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel segment
time frame: 24 months
description: Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in ultrasound evaluation of target vessel segment (if amenable to duplex Doppler examination)
arm group label: CGuard stenting (interventional)
description: CGuard implantation in the carotid artery with aneurysm requiring intervention
intervention type: Device
intervention name: CGuard stent implantation
description: CGuard stent implantation in the carotid artery with symptomatic, dissecting or enlarging aneurysm
arm group label: CGuard stenting (interventional)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Piotr Musialek, MD, DPhil
role: Principal Investigator
affiliation: The John Paul II Hospital
last name: Piotr Musialek, MD, DPhil
phone: +48126142287
email: p.musialek@szpitaljp2.krakow.pl
facility: 
status: Recruiting
contact: 
country: Poland
responsible party type: Sponsor
mesh term: Aneurysm
sharing ipd: No