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/NCT06012123</url>
    </required_header>
    <id_info>
      <org_study_id>PI23-0005</org_study_id>
      <nct_id>NCT06012123</nct_id>
    </id_info>
    <brief_title>BS-CERAB TECHNIQUE</brief_title>
    <acronym>BS-CERAB</acronym>
    <official_title>COMBINATION OF BEGRAFT AND SOLARIS STENTGRAFTS FOR THE COVERED ENDOVASCULAR RECONSTRUCTION OF AORTIC BIFURCATION (BS-CERAB) TECHNIQUE</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery</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>
        The covered endovascular reconstruction of aortic bifurcation (CERAB) technique was described&#xD;
        l in 2013 to reconstruct the aortic bifurcation in a more anatomical and physiological way.&#xD;
        With the use of this technique, a covered stent is expanded 15 to 20 mm above the aortic&#xD;
        bifurcation and this stent is proximally adapted to the aortic wall with a larger balloon,&#xD;
        thereby creating a cone-shaped stent. Two iliac covered stents are then placed in the distal&#xD;
        conic segment and simultaneously inflated, making a tight connection with the aortic stent,&#xD;
        as if they were molded together, thus simulating a new bifurcation. This minimal invasive&#xD;
        endovascular technique using covered stents, was developed in order to optimize endovascular&#xD;
        mimicking the anatomical configuration of the aortic bifurcation and in an attempt to&#xD;
        overcome the disadvantages of kissing stents influenced by geometric factors such as radial&#xD;
        mismatch, protrusion mismatch and stent conformation. The use of BeGraft (balloon-expandalbe&#xD;
        covered stent) and Solaris (self-expandable covered stent) fro this technique is revised.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The covered endovascular reconstruction of aortic bifurcation (CERAB) technique was described&#xD;
        l in 2013 to reconstruct the aortic bifurcation in a more anatomical and physiological way.&#xD;
  &#xD;
        With the use of this technique, a covered stent is expanded 15 to 20 mm above the aortic&#xD;
        bifurcation and this stent is proximally adapted to the aortic wall with a larger balloon,&#xD;
        thereby creating a cone-shaped stent. Two iliac covered stents are then placed in the distal&#xD;
        conic segment and simultaneously inflated, making a tight connection with the aortic stent,&#xD;
        as if they were molded together, thus simulating a new bifurcation.&#xD;
  &#xD;
        This minimal invasive endovascular technique using covered stents, was developed in order to&#xD;
        optimize endovascular mimicking the anatomical configuration of the aortic bifurcation and in&#xD;
        an attempt to overcome the disadvantages of kissing stents influenced by geometric factors&#xD;
        such as radial mismatch, protrusion mismatch and stent conformation.&#xD;
  &#xD;
        The use of BeGraft (balloon-expandalbe covered stent) and Solaris (self-expandable covered&#xD;
        stent) fro this technique is revised.&#xD;
  &#xD;
        A retrospective study included patients that underwent endovascular treatment of&#xD;
        atherosclerotic steno-occlusive aorto-iliac lesions between January 2020 and June 2023. The&#xD;
        study, which received no financial support from industry, was performed in agreement with the&#xD;
        Declaration of Helsinki and was approved by our institutional review boards. In accordance&#xD;
        with institutional and local regulatory policies, this retrospective review of de-identified&#xD;
        procedural and follow-up data was exempt from informed consent.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Actual">August 15, 2023</completion_date>
    <primary_completion_date type="Actual">July 30, 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>12 Months</target_duration>
    <primary_outcome>
      <measure>Primary patency</measure>
      <time_frame>12 months</time_frame>
      <description>Absence of binary restenosis or reocclusion on duplex ultrasound examination without repeat target lesion interventions</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Primary-assisted patency</measure>
      <time_frame>12 months</time_frame>
      <description>Patent aoto-iliac segment that underwent further intervention within the inflow, treated vessel segment, or outflow of the treated vessel segment to improve patency</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary patency</measure>
      <time_frame>12 months</time_frame>
      <description>Requiring a secondary intervention to restore patency after occlusion of the treated segment. Secondary interventions include PTA, drug-eluting balloon PTA (DEB-PTA), additional stent placement or surgical bypass based on clinical deterioration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Amputation rate</measure>
      <time_frame>12 months</time_frame>
      <description>Major and minor amputation rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical status</measure>
      <time_frame>12 months</time_frame>
      <description>Rutherford scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ABI measurements</measure>
      <time_frame>12 months</time_frame>
      <description>Ankle-Brachial index</description>
    </secondary_outcome>
    <enrollment type="Actual">21</enrollment>
    <condition>Aortoiliac Occlusive Disease</condition>
    <condition>Stent Complication</condition>
    <condition>Vascular Device Occlusion</condition>
    <condition>Iliac Artery Stenosis</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Aortoiliac angioplasty and stenting</intervention_name>
      <description>Covered endovascular reconstruction of aortic bifurcation (CERAB) in patient with aorto-iliac occlusive disease</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients that underwent endovascular treatment of atherosclerotic steno-occlusive&#xD;
          aorto-iliac lesions between January 2020 and June 2023.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with lifestyle-limiting intermittent claudication, ischemic rest pain,&#xD;
               ischemic ulcers or gangrene (Rutherford class 3 to 6) who presented steno-occlusive&#xD;
               disease of the aortic bifurcation undergoing endovascular treatment by CERAB and&#xD;
               PTA/covered stenting of iliac arteries&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who could not receive antiplatelet or anticoagulation therapies.&#xD;
  &#xD;
            -  Patients with concomitant aneurysm of the aorta, acute thrombus, unsalvageable limb or&#xD;
               very limited life-expectancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Valladolid Univeristy Hospital</name>
        <address>
          <city>Valladolid</city>
          <zip>47003</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Investigation completion in 6 months, and publication in recognized clinical Journal</ipd_description>
    </patient_data>
    <!-- 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/NCT06012123
  org study id: PI23-0005
  nct id: NCT06012123
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The covered endovascular reconstruction of aortic bifurcation (CERAB) technique was described
        l in 2013 to reconstruct the aortic bifurcation in a more anatomical and physiological way.
        With the use of this technique, a covered stent is expanded 15 to 20 mm above the aortic
        bifurcation and this stent is proximally adapted to the aortic wall with a larger balloon,
        thereby creating a cone-shaped stent. Two iliac covered stents are then placed in the distal
        conic segment and simultaneously inflated, making a tight connection with the aortic stent,
        as if they were molded together, thus simulating a new bifurcation. This minimal invasive
        endovascular technique using covered stents, was developed in order to optimize endovascular
        mimicking the anatomical configuration of the aortic bifurcation and in an attempt to
        overcome the disadvantages of kissing stents influenced by geometric factors such as radial
        mismatch, protrusion mismatch and stent conformation. The use of BeGraft (balloon-expandalbe
        covered stent) and Solaris (self-expandable covered stent) fro this technique is revised.
  The covered endovascular reconstruction of aortic bifurcation (CERAB) technique was described
        l in 2013 to reconstruct the aortic bifurcation in a more anatomical and physiological way.
  
        With the use of this technique, a covered stent is expanded 15 to 20 mm above the aortic
        bifurcation and this stent is proximally adapted to the aortic wall with a larger balloon,
        thereby creating a cone-shaped stent. Two iliac covered stents are then placed in the distal
        conic segment and simultaneously inflated, making a tight connection with the aortic stent,
        as if they were molded together, thus simulating a new bifurcation.
  
        This minimal invasive endovascular technique using covered stents, was developed in order to
        optimize endovascular mimicking the anatomical configuration of the aortic bifurcation and in
        an attempt to overcome the disadvantages of kissing stents influenced by geometric factors
        such as radial mismatch, protrusion mismatch and stent conformation.
  
        The use of BeGraft (balloon-expandalbe covered stent) and Solaris (self-expandable covered
        stent) fro this technique is revised.
  
        A retrospective study included patients that underwent endovascular treatment of
        atherosclerotic steno-occlusive aorto-iliac lesions between January 2020 and June 2023. The
        study, which received no financial support from industry, was performed in agreement with the
        Declaration of Helsinki and was approved by our institutional review boards. In accordance
        with institutional and local regulatory policies, this retrospective review of de-identified
        procedural and follow-up data was exempt from informed consent.
  observational model: Cohort
  time perspective: Prospective
  measure: Primary patency
  time frame: 12 months
  description: Absence of binary restenosis or reocclusion on duplex ultrasound examination without repeat target lesion interventions
  measure: Primary-assisted patency
  time frame: 12 months
  description: Patent aoto-iliac segment that underwent further intervention within the inflow, treated vessel segment, or outflow of the treated vessel segment to improve patency
  measure: Secondary patency
  time frame: 12 months
  description: Requiring a secondary intervention to restore patency after occlusion of the treated segment. Secondary interventions include PTA, drug-eluting balloon PTA (DEB-PTA), additional stent placement or surgical bypass based on clinical deterioration.
  measure: Mortality
  time frame: 12 months
  measure: Amputation rate
  time frame: 12 months
  description: Major and minor amputation rate
  measure: Clinical status
  time frame: 12 months
  description: Rutherford scale
  measure: ABI measurements
  time frame: 12 months
  description: Ankle-Brachial index
  intervention type: Procedure
  intervention name: Aortoiliac angioplasty and stenting
  description: Covered endovascular reconstruction of aortic bifurcation (CERAB) in patient with aorto-iliac occlusive disease
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 100 Years
  healthy volunteers: No
  facility: 
  country: Spain
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: Investigation completion in 6 months, and publication in recognized clinical Journal