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/NCT05983510</url>
    </required_header>
    <id_info>
      <org_study_id>Long term Coral Reef</org_study_id>
      <nct_id>NCT05983510</nct_id>
    </id_info>
    <brief_title>Outcomes After Visceral Aortic Coral Reef Surgery</brief_title>
    <official_title>Long Term Outcomes After Visceral Aortic Endarteriectomy for Coral Reef Lesion</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Paul Sabatier of Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Paul Sabatier of Toulouse</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>
        Coral reef aorta is defined by a calcified stenosis of the visceral aorta which can cause leg&#xD;
        claudication, renal failure and visceral ischemia depending the type and localisation of the&#xD;
        stenosis.&#xD;
  &#xD;
        This pathology is rare and is usually treated by open surgery with aortic endarteriectomy.&#xD;
        Little is know about the outcomes after such aggressive surgery with short series and short&#xD;
        follow up.&#xD;
  &#xD;
        The authors propose a retrospective study from their institution to explore the post&#xD;
        operative and long term outcomes after this surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Coral reef aorta is defined by a calcified stenosis of the visceral aorta which can cause leg&#xD;
        claudication, renal failure and visceral ischemia depending the type and localisation of the&#xD;
        stenosis.&#xD;
  &#xD;
        This pathology is rare and is usually treated by open surgery with aortic endarteriectomy.&#xD;
  &#xD;
        Little is known in the literature regarding the outcomes of this aggressive surgery.&#xD;
  &#xD;
        The authors propose a retrospective study from their institution describing the type of&#xD;
        surgery realised. They describe the post operative outcomes of this surgery in term of&#xD;
        cardiologic, respiratory, renal complication a,d surgical complication.&#xD;
  &#xD;
        Moreover they follow the patients to present long term outcomes of this pathology with a&#xD;
        description of the post operative recurrence of a coral reef, the permeability of the&#xD;
        different target vessel and the cardiologic, respiratory and renal evolution of the different&#xD;
        patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2018</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">January 1, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Major adverse cardiac event (MACE)</measure>
      <time_frame>1 month after surgery</time_frame>
      <description>Post operative cardiologic complication</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reintervention</measure>
      <time_frame>1 month after surgery</time_frame>
      <description>Need of reintervention before discharge</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Long term follow up</measure>
      <time_frame>1 month, 1 year, yearly up to 5 years</time_frame>
      <description>Cumulative survival rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Target vessel patency</measure>
      <time_frame>1 month, 1 year, yearly up to 5 years</time_frame>
      <description>Permeability of the different vessel (renal and visceral arteries) on CT scan or Duplex ultrasound</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Kidney function evolution</measure>
      <time_frame>1 month, 1 year, yearly up to 5 years</time_frame>
      <description>glomerular filtration rate evolution,</description>
    </secondary_outcome>
    <enrollment type="Actual">40</enrollment>
    <condition>Aortic Coral Reef</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Aortic endarteriectomy</intervention_name>
      <description>Thoraco-phreno-lumbotomy with thoracic aortic cross clamping Longitudinal aortotomy Endarteriectomy of the aorta Direct closure more or less bypass to the visceral arteries and downstream aorta reconstruction.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients who needed a coral reef surgery were included&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Coral reef surgery&#xD;
  &#xD;
            -  Urgent intervention&#xD;
  &#xD;
            -  Claudication, renal, visceral involvement&#xD;
  &#xD;
            -  Thoracic aortic cross clamping (above coeliac trunk)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &quot;simple&quot; visceral aorto thrombectomy without opening laterally the aorta&#xD;
  &#xD;
            -  Pregnant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hostalrich Aurélien</name>
        <address>
          <city>Toulouse</city>
          <zip>31059</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Paul Sabatier of Toulouse</investigator_affiliation>
      <investigator_full_name>Aurélien Hostalrich</investigator_full_name>
      <investigator_title>MD,PhD Principal investigator</investigator_title>
    </responsible_party>
    <!-- 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/NCT05983510
  org study id: Long term Coral Reef
  nct id: NCT05983510
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Coral reef aorta is defined by a calcified stenosis of the visceral aorta which can cause leg
        claudication, renal failure and visceral ischemia depending the type and localisation of the
        stenosis.
  
        This pathology is rare and is usually treated by open surgery with aortic endarteriectomy.
        Little is know about the outcomes after such aggressive surgery with short series and short
        follow up.
  
        The authors propose a retrospective study from their institution to explore the post
        operative and long term outcomes after this surgery.
  Coral reef aorta is defined by a calcified stenosis of the visceral aorta which can cause leg
        claudication, renal failure and visceral ischemia depending the type and localisation of the
        stenosis.
  
        This pathology is rare and is usually treated by open surgery with aortic endarteriectomy.
  
        Little is known in the literature regarding the outcomes of this aggressive surgery.
  
        The authors propose a retrospective study from their institution describing the type of
        surgery realised. They describe the post operative outcomes of this surgery in term of
        cardiologic, respiratory, renal complication a,d surgical complication.
  
        Moreover they follow the patients to present long term outcomes of this pathology with a
        description of the post operative recurrence of a coral reef, the permeability of the
        different target vessel and the cardiologic, respiratory and renal evolution of the different
        patients.
  observational model: Cohort
  time perspective: Retrospective
  measure: Major adverse cardiac event (MACE)
  time frame: 1 month after surgery
  description: Post operative cardiologic complication
  measure: Reintervention
  time frame: 1 month after surgery
  description: Need of reintervention before discharge
  measure: Long term follow up
  time frame: 1 month, 1 year, yearly up to 5 years
  description: Cumulative survival rate
  measure: Target vessel patency
  time frame: 1 month, 1 year, yearly up to 5 years
  description: Permeability of the different vessel (renal and visceral arteries) on CT scan or Duplex ultrasound
  measure: Kidney function evolution
  time frame: 1 month, 1 year, yearly up to 5 years
  description: glomerular filtration rate evolution,
  intervention type: Procedure
  intervention name: Aortic endarteriectomy
  description: Thoraco-phreno-lumbotomy with thoracic aortic cross clamping Longitudinal aortotomy Endarteriectomy of the aorta Direct closure more or less bypass to the visceral arteries and downstream aorta reconstruction.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: France
  responsible party type: Principal Investigator
  investigator affiliation: University Paul Sabatier of Toulouse
  investigator full name: Aurélien Hostalrich
  investigator title: MD,PhD Principal investigator