<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/NCT03762525</url>
  </required_header>
  <id_info>
    <org_study_id>IBD-dynamics</org_study_id>
    <nct_id>NCT03762525</nct_id>
  </id_info>
  <brief_title>Iliac Branch Device Movement During Cardiac Cycle (IBD-dynamics)</brief_title>
  <official_title>Anatomic Dynamics of the Internal Iliac Artery After Placement of Iliac Branched Devices Using ECG-gated Computer Tomography Angiography Imaging (IBD-dynamics)</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>
      The incidence of isolated common iliac artery (CIA) aneurysms is low, but in combination with&#xD;
      an abdominal aortic aneurysm (AAA) they are found in approximately 20-40% of cases.&#xD;
      Basically, two different endovascular strategies can be applied to treat a CIA aneurysm with,&#xD;
      including 1. the coverage and 2. the preservation of blood flow to the internal iliac artery&#xD;
      (IIA). Coil and coverage of the IIA is related to ischemic complications, including buttock&#xD;
      claudication, erectile dysfunction and the more severe spinal and colonic ischemia. Iliac&#xD;
      branched devices (IBD) have been developed to exclude CIA aneurysms preserving the IIA and&#xD;
      currently three alternatives are on the market. Clinical results of these devices are&#xD;
      promising but loss of patency is not uncommon. The major difference between the two devices&#xD;
      is the IIA component. The Cook IBD uses a -non-dedicated IIA component, while in the GORE®&#xD;
      EXCLUDER® Iliac Branch Endoprosthesis (Gore IBE device) a dedicated self expanding stent is&#xD;
      used. Stresses and forces exerted onto the endograft by aortic pulsatility may have an effect&#xD;
      on the durability and functioning of the endograft. Intermittent hinchpoints could also have&#xD;
      an effect on stent integrity and stenosis. By evaluating endograft movement during the&#xD;
      cardiac cycle (ECG-gated CTA) it is possible to assess the stress and force exerted onto the&#xD;
      endograft. This might help gain insight into mechanisms underlying potential endograft&#xD;
      failure, and aid procedural planning and the development of future devices with long-term&#xD;
      durability.&#xD;
&#xD;
      The choice for device is not part of this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:To compare the mobility of the hypogastic artery during the cardiac cycle before&#xD;
      and six weeks after implantation of the Gore IBE device in conjunction with its dedicated&#xD;
      self expandable Internal Iliac component (Sub-study A);and to quantitatively characterize the&#xD;
      displacement of stents with regard to the main body and native IIA during the cardiac cycle&#xD;
      on an implanted iliac branched endograft in conjunction with a non-dedicated IIA component&#xD;
      (Cook IBD with Advanta V12 or Fluency) with those in conjunction with a dedicated self&#xD;
      expandable Internal Iliac component (Gore IBE device). (Sub-study B) Study design: Sub-study&#xD;
      A &amp; B: Multicenter observational case studies Study population: Sub-study A: 15 prospectively&#xD;
      included patients and sub-study B: 15 patients in each group that have been treated in the&#xD;
      period October 2006 - July 2016.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2016</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This study is designed as a multicenter prospective case series.&#xD;
To prospectively enroll 15 patients that are scheduled for endovascular aneurysm repair using the Gore IBE device in conjunction with its dedicated self expanding Internal Iliac component.&#xD;
Tocompare 15 patients that have been treated in the period October 2006- July 2016 with the Cook IBD with a non-dedicated IIA component (Advanta-V12 or Fluency) and 15 matched patients treated with Gore IBE device.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The choice for the device is not part of this study and will be made by the doctor in consultation with the patient and the patients anatomy.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mobility of hypogastric artery during cardiac cycle (sub study A)</measure>
    <time_frame>Up to 1 year follow-up</time_frame>
    <description>The mobility of the hypogastic artery during the cardiac cycle before and after implantation of the Gore IBE device (Sub-study A). This will be measured at 15 patients by making an ECG gated CTA per and postoperative.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characterize displacement during cardiac cycle (Sub Study B)</measure>
    <time_frame>Up to 1 year follow-up</time_frame>
    <description>To quantitatively characterize the displacement during the cardiac cycle on an implanted iliac branched endograft in conjunction with a non-dedicated n balloon expandable IIA component (Cook IBD with Advanta V12 or Fluency) with those in conjunction with a dedicated self expandable Internal Iliac cComponent (Gore IBE device). (Sub-study B). This will be measured by 30 patients (15 pt Cook IBD and 15 pt Gore IBE) an ECG gated CTA postoperative.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Iliac Aneurysm</condition>
  <condition>Angiography</condition>
  <condition>AAA</condition>
  <arm_group>
    <arm_group_label>ECG gated CTA pre and post operative at Gore IBE</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>To prospectively enroll 15 patients that are scheduled for endovascular aneurysm repair using the Gore IBE device in conjunction with its dedicated self expanding Internal Iliac component. Each patient will have an ECG gated CTA scan before the operation and 6-8 weeks after operation, in stead of a regular CT scan.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ECG gated CTA post operative at Gore IBE and Cook IBD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>To compare 15 patients that have been treated in the period October 2006- July 2016 with the Cook IBD with a non-dedicated IIA component (Advanta-V12 or Fluency) and 15 matched patients treated with Gore IBE device. Each patient will have an ECG gated CTA after the operation, at the first doctor's appointment, in stead of a regular CT scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>ECG gated CTA</intervention_name>
    <description>Routine care consists of a preoperative and several postoperative CTA scans. In A. The preoperative and first postoperative CTA will be replaced by ECG-gated CTA imaging and in B. the scheduled imaging will be replaced by an ECG-gated CTA.&#xD;
General information: The protocol is based on the ECG gated cardiac protocol using abdominal parameter settings.</description>
    <arm_group_label>ECG gated CTA post operative at Gore IBE and Cook IBD</arm_group_label>
    <arm_group_label>ECG gated CTA pre and post operative at Gore IBE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sub-study A. scheduled endovascular aneurysm repair using the Gore IBE device.&#xD;
&#xD;
          -  Sub-study B. Patients that have been treated with an iliac branched device in the past&#xD;
             in conjunction with either a dedicated IIA component (Gore IBE device) or&#xD;
             non-dedicated IIA component (Cook IBD) and who are scheduled for follow-up imaging&#xD;
             within the period July 2016-January 2017.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No specific exclusion criteria. Patients will be treated according to the hospital's&#xD;
             standard practice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</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>Rijnstate Hospital</name>
      <address>
        <city>Arnhem</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elisabeth Tweesteden ziekenhuis</name>
      <address>
        <city>Tilburg</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>October 5, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</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>Prof. Dr., Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Iliac 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/NCT03762525
org study id: IBD-dynamics
nct id: NCT03762525
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The incidence of isolated common iliac artery (CIA) aneurysms is low, but in combination with
      an abdominal aortic aneurysm (AAA) they are found in approximately 20-40% of cases.
      Basically, two different endovascular strategies can be applied to treat a CIA aneurysm with,
      including 1. the coverage and 2. the preservation of blood flow to the internal iliac artery
      (IIA). Coil and coverage of the IIA is related to ischemic complications, including buttock
      claudication, erectile dysfunction and the more severe spinal and colonic ischemia. Iliac
      branched devices (IBD) have been developed to exclude CIA aneurysms preserving the IIA and
      currently three alternatives are on the market. Clinical results of these devices are
      promising but loss of patency is not uncommon. The major difference between the two devices
      is the IIA component. The Cook IBD uses a -non-dedicated IIA component, while in the GORE®
      EXCLUDER® Iliac Branch Endoprosthesis (Gore IBE device) a dedicated self expanding stent is
      used. Stresses and forces exerted onto the endograft by aortic pulsatility may have an effect
      on the durability and functioning of the endograft. Intermittent hinchpoints could also have
      an effect on stent integrity and stenosis. By evaluating endograft movement during the
      cardiac cycle (ECG-gated CTA) it is possible to assess the stress and force exerted onto the
      endograft. This might help gain insight into mechanisms underlying potential endograft
      failure, and aid procedural planning and the development of future devices with long-term
      durability.

      The choice for device is not part of this study.
Objectives:To compare the mobility of the hypogastic artery during the cardiac cycle before
      and six weeks after implantation of the Gore IBE device in conjunction with its dedicated
      self expandable Internal Iliac component (Sub-study A);and to quantitatively characterize the
      displacement of stents with regard to the main body and native IIA during the cardiac cycle
      on an implanted iliac branched endograft in conjunction with a non-dedicated IIA component
      (Cook IBD with Advanta V12 or Fluency) with those in conjunction with a dedicated self
      expandable Internal Iliac component (Gore IBE device). (Sub-study B) Study design: Sub-study
      A & B: Multicenter observational case studies Study population: Sub-study A: 15 prospectively
      included patients and sub-study B: 15 patients in each group that have been treated in the
      period October 2006 - July 2016.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: This study is designed as a multicenter prospective case series.
To prospectively enroll 15 patients that are scheduled for endovascular aneurysm repair using the Gore IBE device in conjunction with its dedicated self expanding Internal Iliac component.
Tocompare 15 patients that have been treated in the period October 2006- July 2016 with the Cook IBD with a non-dedicated IIA component (Advanta-V12 or Fluency) and 15 matched patients treated with Gore IBE device.
primary purpose: Other
masking: None (Open Label)
masking description: The choice for the device is not part of this study and will be made by the doctor in consultation with the patient and the patients anatomy.
measure: Mobility of hypogastric artery during cardiac cycle (sub study A)
time frame: Up to 1 year follow-up
description: The mobility of the hypogastic artery during the cardiac cycle before and after implantation of the Gore IBE device (Sub-study A). This will be measured at 15 patients by making an ECG gated CTA per and postoperative.
measure: Characterize displacement during cardiac cycle (Sub Study B)
time frame: Up to 1 year follow-up
description: To quantitatively characterize the displacement during the cardiac cycle on an implanted iliac branched endograft in conjunction with a non-dedicated n balloon expandable IIA component (Cook IBD with Advanta V12 or Fluency) with those in conjunction with a dedicated self expandable Internal Iliac cComponent (Gore IBE device). (Sub-study B). This will be measured by 30 patients (15 pt Cook IBD and 15 pt Gore IBE) an ECG gated CTA postoperative.
arm group label: ECG gated CTA pre and post operative at Gore IBE
arm group type: Other
description: To prospectively enroll 15 patients that are scheduled for endovascular aneurysm repair using the Gore IBE device in conjunction with its dedicated self expanding Internal Iliac component. Each patient will have an ECG gated CTA scan before the operation and 6-8 weeks after operation, in stead of a regular CT scan.
arm group label: ECG gated CTA post operative at Gore IBE and Cook IBD
arm group type: Other
description: To compare 15 patients that have been treated in the period October 2006- July 2016 with the Cook IBD with a non-dedicated IIA component (Advanta-V12 or Fluency) and 15 matched patients treated with Gore IBE device. Each patient will have an ECG gated CTA after the operation, at the first doctor's appointment, in stead of a regular CT scan.
intervention type: Radiation
intervention name: ECG gated CTA
description: Routine care consists of a preoperative and several postoperative CTA scans. In A. The preoperative and first postoperative CTA will be replaced by ECG-gated CTA imaging and in B. the scheduled imaging will be replaced by an ECG-gated CTA.
General information: The protocol is based on the ECG gated cardiac protocol using abdominal parameter settings.
arm group label: ECG gated CTA post operative at Gore IBE and Cook IBD
arm group label: ECG gated CTA pre and post operative at Gore IBE
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Michel Reijnen, MD, PhD
role: Principal Investigator
affiliation: Principal Investigator
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Rijnstate Hospital
investigator full name: Michel Reijnen
investigator title: Prof. Dr., Principal Investigator
mesh term: Aneurysm
mesh term: Iliac Aneurysm
sharing ipd: No