<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/NCT03767686</url>
  </required_header>
  <id_info>
    <org_study_id>CERAB trial</org_study_id>
    <nct_id>NCT03767686</nct_id>
  </id_info>
  <brief_title>Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease</brief_title>
  <official_title>Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease A Multicenter, Prospective Investigator Initiated Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rijnstate Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rijnstate Hospital</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>
      Endovascular treatment is rapidly taking over surgery for aorto-iliac occlusive disease&#xD;
      (AOID), also in extensive pathology. This is related to its minimally invasiveness,&#xD;
      decreasing the procedural morbidity rate. When the aortic bifurcation was involved in the&#xD;
      lesion, the patency rates of kissing stents configurations were often inferior to open&#xD;
      repair. In 2013 the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB)&#xD;
      technique was introduced in an attempt to improve endovascular treatment results by a more&#xD;
      anatomical and physiological reconstruction, with a subsequent improved clinical outcome.&#xD;
&#xD;
      This investigator-initiated multicenter trial will prospectively record all data on performed&#xD;
      CERAB procedures using the Bentley balloon expandable covered stents (BeGraft Aortic and&#xD;
      BeGraft Peripheral) in multiple International sites, in order to gain more robust real-world&#xD;
      data on the efficacy of these stent grafts for this indication.&#xD;
&#xD;
      Consecutive patients in whom a CERAB will be performed with these particular covered stents&#xD;
      in the participating centers.&#xD;
&#xD;
      Main study parameters/endpoints: The primary end-point of this study is technical success.&#xD;
      Patency rates, peri-procedural morbidity, clinical improvement, quality of life,&#xD;
      clinically-driven target vessel revascularization and reintervention-rate will be secondary&#xD;
      outcome measures. Overall, patients will be followed for 5 years&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endovascular treatment is rapidly taking over surgery for aorto-iliac occlusive disease&#xD;
      (AOID) also for complex lesions. This is related to the minimally invasiveness of the&#xD;
      procedure decreasing the morbidity rate. Patency results of endovascular treatment were often&#xD;
      inferior compared to open repair when the aortic bifurcation was involved in the lesion. In&#xD;
      2013 Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique was&#xD;
      introduced in an attempt to improve endovascular treatment results by a more anatomical and&#xD;
      physiological reconstruction, with a subsequent better clinical outcome. The early results of&#xD;
      the CERAB configuration are promising with primary, primary-assisted and secondary patency&#xD;
      of, respectively 86.2%/91.1%/97.0% at 1-year, 83.9%/88.7%/97.0% at 2-year and&#xD;
      82.1%/86.8%/97.0% at 3-year FU in a group of 130 patients, including the first in man&#xD;
      results. The vast majority (89.2%) were TASC-II D lesions and the 30-day major complication&#xD;
      rate was 7.7%.&#xD;
&#xD;
      This trial is designed to prospectively collect all data on implanted CERAB configurations,&#xD;
      using the balloon expandable stents from Bentley InnoMed, in a defined group of aorto-iliac&#xD;
      pathology in multiple international sites in order to gain more insight in the outcome of the&#xD;
      technique. Technical success will be the primary endpoint. Other evaluations will include&#xD;
      patency rates, quality of life, the reintervention-rate, 30-day morbidity and target vessel&#xD;
      revascularization up to 5 years after treatment.&#xD;
&#xD;
      A total of 145 patients will be included and followed until 5 years of follow-up. A core lab&#xD;
      will independently analyze the images (CT scan or duplex) which will be made at the following&#xD;
      time points: pre-op, 1 month, 6 months, 1 year and yearly up to 5 years of follow-up.&#xD;
&#xD;
      Additionally, at these time points three questionnaires will be completed by the patients.&#xD;
      These questionnaires are about walking ability (WIQ), and quality of life (EQ-5D and&#xD;
      WHOQoL-BREF).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Finance stop&#xD;
  </why_stopped>
  <start_date type="Actual">March 23, 2019</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2020</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>Technical success</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Technical success is defined as successful implantation of the CERAB device without occlusion during the first 30-days after implantation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary patency</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Primary patency at 12 months measured by duplex ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Technical success</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Technical success is defined as successful implantation of the CERAB device without conversion to open repair</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>Up to 5 years of follow-up</time_frame>
    <description>Patency rates measured by duplex ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>Up to 5 years of follow-up</time_frame>
    <description>Target vessel revascularization measured by duplex ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>Up to 5 years of follow-up</time_frame>
    <description>Conversion to open surgery judged at every clinic visit by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 5 years of follow-up</time_frame>
    <description>Freedom from reinterventions judged at every clinic visit by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 30 days of follow-up</time_frame>
    <description>30 days morbidity judged at every clinic visit by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 3 months of follow-up</time_frame>
    <description>Incidence serious adverse events device related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 6 months of follow-up</time_frame>
    <description>Incidence serious adverse events device related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 12 months of follow-up</time_frame>
    <description>Incidence serious adverse events device related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 3 months of follow-up</time_frame>
    <description>Incidence of serious adverse events procedure related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 6 months of follow-up</time_frame>
    <description>Incidence of serious adverse events procedure related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 12 months of follow-up</time_frame>
    <description>Incidence of serious adverse events procedure related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 5 years of follow-up</time_frame>
    <description>Overall survival investigated with every clinic visit, done by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 5 years of follow-up</time_frame>
    <description>Reintervention-free survival investigated with every clinic visit, done by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 5 years of follow-up</time_frame>
    <description>Clinical improvement as measured by the Rutherford category of which 1 is better dan 6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 5 years of follow-up</time_frame>
    <description>Patient reported outcomes measured by the EQ-5D questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 5 years of follow-up</time_frame>
    <description>Patient reported outcomes measured by the Walking Impairment Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>Up to 5 years of follow-up</time_frame>
    <description>Patient reported outcomes measured by the WHOQoL Bref</description>
  </secondary_outcome>
  <enrollment type="Actual">28</enrollment>
  <condition>Aorto-Iliac Atherosclerosis</condition>
  <condition>Aortoiliac Obstruction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include 145 patients in whom a CERAB will be performed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Provided written informed consent&#xD;
&#xD;
          -  Clinical necessity for treatment&#xD;
&#xD;
          -  Eligible anatomy for CERAB without the need for chimney's&#xD;
&#xD;
          -  TASC-2 classification as assigned in the study protocol (specified type B, C and D&#xD;
             lesions)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is participating in another conflicting clinical study&#xD;
&#xD;
          -  Patient's life expectancy &lt;2 years as judged by the investigator&#xD;
&#xD;
          -  Patient has a psychiatric or other condition that may interfere with the study&#xD;
&#xD;
          -  Patient has a known allergy to any device component&#xD;
&#xD;
          -  Patients with a systemic infection who may be at increased risk of endovascular graft&#xD;
             infection.&#xD;
&#xD;
          -  Patient has a coagulopathy or uncontrolled bleeding disorder&#xD;
&#xD;
          -  Patient had a CVA or an MI within the prior three months&#xD;
&#xD;
          -  Patient is pregnant (Female patients of childbearing potential only)&#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>Michel Reijnen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dandenong Hospital</name>
      <address>
        <city>Victoria Point</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spanish Hospital</name>
      <address>
        <city>Mexico City</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rijnstate Hospital</name>
      <address>
        <city>Arnhem</city>
        <state>Gelderland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dijklander Ziekenhuis</name>
      <address>
        <city>Hoorn</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University Center Maastricht</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waikato Hospital</name>
      <address>
        <city>Hamilton</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>March 30, 2020</last_update_submitted>
  <last_update_submitted_qc>March 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rijnstate Hospital</investigator_affiliation>
    <investigator_full_name>Michel Reijnen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Leriche Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT03767686
org study id: CERAB trial
nct id: NCT03767686
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endovascular treatment is rapidly taking over surgery for aorto-iliac occlusive disease
      (AOID), also in extensive pathology. This is related to its minimally invasiveness,
      decreasing the procedural morbidity rate. When the aortic bifurcation was involved in the
      lesion, the patency rates of kissing stents configurations were often inferior to open
      repair. In 2013 the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB)
      technique was introduced in an attempt to improve endovascular treatment results by a more
      anatomical and physiological reconstruction, with a subsequent improved clinical outcome.

      This investigator-initiated multicenter trial will prospectively record all data on performed
      CERAB procedures using the Bentley balloon expandable covered stents (BeGraft Aortic and
      BeGraft Peripheral) in multiple International sites, in order to gain more robust real-world
      data on the efficacy of these stent grafts for this indication.

      Consecutive patients in whom a CERAB will be performed with these particular covered stents
      in the participating centers.

      Main study parameters/endpoints: The primary end-point of this study is technical success.
      Patency rates, peri-procedural morbidity, clinical improvement, quality of life,
      clinically-driven target vessel revascularization and reintervention-rate will be secondary
      outcome measures. Overall, patients will be followed for 5 years
Endovascular treatment is rapidly taking over surgery for aorto-iliac occlusive disease
      (AOID) also for complex lesions. This is related to the minimally invasiveness of the
      procedure decreasing the morbidity rate. Patency results of endovascular treatment were often
      inferior compared to open repair when the aortic bifurcation was involved in the lesion. In
      2013 Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique was
      introduced in an attempt to improve endovascular treatment results by a more anatomical and
      physiological reconstruction, with a subsequent better clinical outcome. The early results of
      the CERAB configuration are promising with primary, primary-assisted and secondary patency
      of, respectively 86.2%/91.1%/97.0% at 1-year, 83.9%/88.7%/97.0% at 2-year and
      82.1%/86.8%/97.0% at 3-year FU in a group of 130 patients, including the first in man
      results. The vast majority (89.2%) were TASC-II D lesions and the 30-day major complication
      rate was 7.7%.

      This trial is designed to prospectively collect all data on implanted CERAB configurations,
      using the balloon expandable stents from Bentley InnoMed, in a defined group of aorto-iliac
      pathology in multiple international sites in order to gain more insight in the outcome of the
      technique. Technical success will be the primary endpoint. Other evaluations will include
      patency rates, quality of life, the reintervention-rate, 30-day morbidity and target vessel
      revascularization up to 5 years after treatment.

      A total of 145 patients will be included and followed until 5 years of follow-up. A core lab
      will independently analyze the images (CT scan or duplex) which will be made at the following
      time points: pre-op, 1 month, 6 months, 1 year and yearly up to 5 years of follow-up.

      Additionally, at these time points three questionnaires will be completed by the patients.
      These questionnaires are about walking ability (WIQ), and quality of life (EQ-5D and
      WHOQoL-BREF).
observational model: Cohort
time perspective: Prospective
measure: Technical success
time frame: Up to 30 days
description: Technical success is defined as successful implantation of the CERAB device without occlusion during the first 30-days after implantation
measure: Primary patency
time frame: Up to 12 months
description: Primary patency at 12 months measured by duplex ultrasound
measure: Technical success
time frame: Up to 30 days
description: Technical success is defined as successful implantation of the CERAB device without conversion to open repair
measure: Technical success
time frame: Up to 5 years of follow-up
description: Patency rates measured by duplex ultrasound
measure: Technical success
time frame: Up to 5 years of follow-up
description: Target vessel revascularization measured by duplex ultrasound
measure: Technical success
time frame: Up to 5 years of follow-up
description: Conversion to open surgery judged at every clinic visit by the investigator
measure: Clinical success
time frame: Up to 5 years of follow-up
description: Freedom from reinterventions judged at every clinic visit by the investigator
measure: Clinical success
time frame: Up to 30 days of follow-up
description: 30 days morbidity judged at every clinic visit by the investigator
measure: Clinical success
time frame: Up to 3 months of follow-up
description: Incidence serious adverse events device related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator
measure: Clinical success
time frame: Up to 6 months of follow-up
description: Incidence serious adverse events device related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator
measure: Clinical success
time frame: Up to 12 months of follow-up
description: Incidence serious adverse events device related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator
measure: Clinical success
time frame: Up to 3 months of follow-up
description: Incidence of serious adverse events procedure related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator
measure: Clinical success
time frame: Up to 6 months of follow-up
description: Incidence of serious adverse events procedure related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator
measure: Clinical success
time frame: Up to 12 months of follow-up
description: Incidence of serious adverse events procedure related judged at every clinic visit and in between visits if the investigator notes that an AE appeared, done by the investigator
measure: Clinical success
time frame: Up to 5 years of follow-up
description: Overall survival investigated with every clinic visit, done by the investigator
measure: Clinical success
time frame: Up to 5 years of follow-up
description: Reintervention-free survival investigated with every clinic visit, done by the investigator
measure: Clinical success
time frame: Up to 5 years of follow-up
description: Clinical improvement as measured by the Rutherford category of which 1 is better dan 6
measure: Clinical success
time frame: Up to 5 years of follow-up
description: Patient reported outcomes measured by the EQ-5D questionnaire
measure: Clinical success
time frame: Up to 5 years of follow-up
description: Patient reported outcomes measured by the Walking Impairment Questionnaire
measure: Clinical success
time frame: Up to 5 years of follow-up
description: Patient reported outcomes measured by the WHOQoL Bref
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michel Reijnen, MD, PhD
role: Principal Investigator
affiliation: Principal Investigator
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Italy
country: Mexico
country: Netherlands
country: New Zealand
responsible party type: Principal Investigator
investigator affiliation: Rijnstate Hospital
investigator full name: Michel Reijnen
investigator title: Principal Investigator
mesh term: Atherosclerosis
mesh term: Leriche Syndrome