<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/NCT03024554</url>
  </required_header>
  <id_info>
    <org_study_id>12-2013</org_study_id>
    <nct_id>NCT03024554</nct_id>
  </id_info>
  <brief_title>Evaluation of Safety and Efficacy of the Bifurcated Multilayer Flow Modulator (BMFM®).</brief_title>
  <acronym>STREAMLINER</acronym>
  <official_title>Evaluation of Safety and Efficacy of the Bifurcated Multilayer Flow Modulator (BMFM®).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiatis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiatis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the safety and efficacy of the BMFM® kit in the use for the endovascular&#xD;
      treatment of aortic aneurysms involving iliac arteries. The BMFM® kit is an adaptation of the&#xD;
      aortic MFM® to the aortoiliac bifurcation morphology. It should be noted that the aortic MFM®&#xD;
      has CE mark approval for the aortic aneurysm treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endovascular approaches to TAAAs have evolved during the past decade. The initial experiences&#xD;
      with fenestrated and branched endografts have shown that total endovascular repair is&#xD;
      effective and may reduce morbidity rates in patients with arch, thoracoabdominal and&#xD;
      pararenal aneurysms.&#xD;
&#xD;
      The Cleveland Clinic group has recently reported on their updated clinical experience with&#xD;
      the first 633 patients treated by fenestrated and branched endografts. Operative mortality&#xD;
      was 1.8% for pararenal, 5.2% for types I to III, and 2.3% for type IV TAAAs .&#xD;
&#xD;
      However, 30-40% of TAAA patients remain unsuitable for EVAR due to unfavorable proximal neck&#xD;
      anatomy. There is also an increased incidence of type I proximal endoleak when established&#xD;
      f-EVAR guidelines are disregarded, often leading to endovascular re-intervention or surgical&#xD;
      conversion.&#xD;
&#xD;
      Currently, the use of the bifurcated stent-graft for the infrarenal aneurysm involving iliac&#xD;
      arteries treatment has received wide distribution. The application of endovascular technology&#xD;
      to treat infrarenal aneurysm is now commonplace because the implantation of an infrarenal&#xD;
      endoprosthesis is a relatively simple procedure requiring adequately long proximal seal zone,&#xD;
      diameter measurements and accurate longitudinal device placement. However, designing and&#xD;
      implanting a device, which will accommodate the visceral branches, is more complex.&#xD;
&#xD;
      The infrarenal with unfavorable or insufficient proximal neck as well as juxtarenal&#xD;
      aneurysms, which involve iliac arteries, could be treated by combination of the Fenestrated&#xD;
      Stent Graft with the Bifurcated Stent Graft.&#xD;
&#xD;
      The principal limitation of this technology is the customized nature of fenestrated&#xD;
      stent-graft design. From planning to delivery, the process may take in excess of 6 weeks,&#xD;
      which restricts the application of f-EVAR to stable elective patients. This procedure is&#xD;
      complex, costly and the implantation time is quite long. It must be conducted in expert&#xD;
      centers with sophisticated infrastructure (hybrid room). Preservation of visceral aortic&#xD;
      branches requires precise graft construction and deployment.&#xD;
&#xD;
      There are reports in the literature of emergent f-EVAR, but the success of these procedures&#xD;
      relies on on-site modification of commercially available endografts.&#xD;
&#xD;
      Until an &quot;off-the-shelf'' device is designed to be compatible with the majority of patients,&#xD;
      ''off-label'' surgeon-modified devices remain the only option in emergencies when open repair&#xD;
      is prohibited. The &quot;off-the-shelf&quot; devices are likely to allow treatment of more than 60% to&#xD;
      80% of patients with complex aneurysms but these standardized designs have not yet been&#xD;
      tested clinically in large number of patients with long follow-up In the absence of widely&#xD;
      available endografts designs, a number of centers have reported creative techniques to&#xD;
      incorporate the visceral arteries, such as &quot;chimney&quot;, &quot;sandwich&quot; , &quot;octopus&quot; , &quot;periscope&quot;&#xD;
      and physician-modified endografts. However, these approaches are limited by off-label&#xD;
      indications, lack of quality control, violation of basic engineering concepts and&#xD;
      questionable durability.&#xD;
&#xD;
      One of the drawbacks linked to the use of parallel endografts (mainly for the &quot;chimney&#xD;
      technique&quot;) remains the imperfect seal inherent to this technique. This side by side&#xD;
      configuration leads to gutter along the parallel endografts, which can result in type I&#xD;
      endoleaks between the main body of the graft and branched grafts; &quot;Gutter endoleaks&quot;&#xD;
      continuously pressurize the aneurysm. The gutters between the main aortic graft, the chimney&#xD;
      graft (GC), and the aortic wall should be as narrow as possible to avoid endoleaks, which can&#xD;
      be harmful and -almost always- require re-intervention.&#xD;
&#xD;
      Thoraco Abdominal Aneurysms involving iliac arteries remain a challenge for EVAR. Dilatation&#xD;
      of the common iliac artery (CIA) often leaves no distal landing zone for commercially&#xD;
      available stent grafts, which have a maximum diameter of 28 mm. Furthermore, aneurysms&#xD;
      extended to the internal iliac artery (IIA) make endovascular repair even more difficult.&#xD;
&#xD;
      A common method allowing endovascular treatment of these aneurysms is occlusion of the IIA,&#xD;
      thereby creating a distal landing zone in the external iliac artery (EIA). However,&#xD;
      sacrificing the pelvic blood flow while occluding the internal iliac artery often results in&#xD;
      buttock claudication and impotence, as well as other complications such as colonic&#xD;
      infarction, gut or spinal cord ischemia. The frequency of these complications varies between&#xD;
      13% and 55% and they can impair quality of life substantially.&#xD;
&#xD;
      Successful treatment of aortoiliac aneurysms involves branch vessel preservation and&#xD;
      long-term protection from rupture. While EVAR has totally eclipsed open surgery because of&#xD;
      its lower mortality and morbidities, the durability of EVAR can be questioned because of the&#xD;
      need for re-intervention and incidence of late aneurysm-related complications . Notably,&#xD;
      long-term failure can arise because of the loss of proper seal at the proximal or distal&#xD;
      landing zone of the stent-graft (type I endoleaks). Importantly, common iliac diameter can be&#xD;
      considered as a predictor of late sac enlargement, as well as implantation outside&#xD;
      Manufacturer's Instructions For Use (IFU). Furthermore, Benharash et al. managed to&#xD;
      demonstrate that iliac fixation is of high importance for the prevention of device migration,&#xD;
      regardless of proximal attachment type.&#xD;
&#xD;
      Iliac artery involvement incidence in abdominal aortic aneurysms (AAAs) is estimated at 20 to&#xD;
      30 %. Hence, nearly a third of all patients presenting with AAAs for repair might not fit&#xD;
      within the IFU for standard EVAR device based on iliac diameters. A common approach to ensure&#xD;
      appropriate landing zone for iliac components of endografts involves extension into the&#xD;
      external iliac artery, with or without concomitant hypogastric artery embolization and&#xD;
      coverage. While unilateral coiling has been demonstrated to have relatively low rates of&#xD;
      complication, occlusion of the hypogastric artery due to stent graft placement can lead to&#xD;
      major complications, as mentioned above. Given the significant morbidity associated with&#xD;
      these complications, industry has developed branch technology for hypogastric preservation.&#xD;
&#xD;
      The Multilayer Flow Modulator (MFM®) provides a less complex interventional approach for&#xD;
      aortic aneurysm treatment. This device is an uncovered, self-expanding wire mesh with high&#xD;
      radial force and flexibility. It is designed to modulate blood-flow dynamics by relieving&#xD;
      local peak wall shear stress (PWSS), achieving stabilization of aneurysm-sac or false lumen&#xD;
      pressure and preserving side-branch patency.&#xD;
&#xD;
      The clinical benefits of this technology have been assessed and shown in case reports and&#xD;
      clinical studies of thoracoabdominal aneurysm, type B dissection, pararenal aortic aneurysm&#xD;
      and peripheral artery aneurysm (celiac, hepatic, renal, iliac, subclavian) (48-79). Also the&#xD;
      prospective multicenter registry of peripheral and visceral aneurysms (69) and the&#xD;
      prospective multicenter STRATO Trial of TAAA (78), show good results at 12-month follow-up.&#xD;
&#xD;
      The MFM® eliminates flow vortex pressure and laminates the outside the device along the&#xD;
      aneurysm wall in the same direction of the blood stream. Laminated flow possess unique and&#xD;
      protective effects on endothelial cells as well as the ability to promote thrombus&#xD;
      progressive formation within the aneurysmal sac. The MFM® addresses not only those issues in&#xD;
      a very unique fashion, providing a uniform interface between the artery wall and the blood&#xD;
      flow, but its favorable compliance means the device will not be subjected to the same drag&#xD;
      forces a conventional stent graft will undergo..&#xD;
&#xD;
      Laminating the blood flow within the aneurysm, promoting thrombus formation within the&#xD;
      aneurysmal sac and re-establishing a favorable biochemical and biomechanical balance of&#xD;
      endothelial homeostasis, the MFM® addresses aneurysm related issues and outcomes in a novel&#xD;
      manner. With aneurysmal stabilization and thrombosis, the MFM® excludes the aneurysm from the&#xD;
      circulation rather physically and physiologically than mechanically, as other conventional&#xD;
      grafts do. Thanks to the intrinsic porosity of the device, branches are kept patent and well&#xD;
      perfused, thus abolishing the risk for collaterals occlusion and consequent ischemia.&#xD;
&#xD;
      STREAMLINER study is an international, multicentre, prospective, non-randomized study. It is&#xD;
      designed to evaluate the safety and efficacy of BMFM® kit use. Approximately 40 patients,&#xD;
      from up to 12 centres in Europe, Israel, Morocco, Bahrain and Turkey, will be enrolled and&#xD;
      screened per the protocol-required inclusion, exclusion criteria, in order to obtain 30&#xD;
      completed patients. The results will be compared with published results for other treatment&#xD;
      modalities in the literature. Patients will be included only after obtaining fully informed&#xD;
      consent, after conducting all pre-operative examinations required, with respect for all&#xD;
      inclusion and exclusion criteria. For early demonstration of efficacy and safety an interim&#xD;
      analysis will be performed after the 10 first enrolled patients will complete their 6 months&#xD;
      follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with unruptured aneurysm</measure>
    <time_frame>12 months</time_frame>
    <description>the prevention of aortic aneurysm rupture by the BMFM, in stabilizing it, will be evaluated with the number of patient presenting with unruptured aneurysm at the specified timepoint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality 30 days, 6 months and 1 year aneurysm-related</measure>
    <time_frame>30 days, 6 months and 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of branches and collaterals patent</measure>
    <time_frame>12 months</time_frame>
    <description>The patency of branches will be evaluated as follows: the number of branches patent will be evaluated on the total number of branches covered by the device (baseline data)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality 30 days, 6 months and 1 year not aneurysm-related</measure>
    <time_frame>30 days, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Major Adverse Events</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patients with Major Adverse Evens</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>The technical success is evaluated/recorded post-procedure and presented in the 12 months report.</time_frame>
    <description>successful delivery and deployment of the BMFM® kit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural/in-hospital evaluations (Anesthesia time)</measure>
    <time_frame>The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.</time_frame>
    <description>descriptive statistics on Anesthesia time (min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural/in-hospital evaluations (Fluoroscopy time)</measure>
    <time_frame>The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.</time_frame>
    <description>Descriptive Statistics on fluoroscopy time (min)procedure time; time to hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural/in-hospital evaluations (Constrast Volume)</measure>
    <time_frame>The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.</time_frame>
    <description>Descriptive Statistics on contrast product volume (ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural/in-hospital evaluations (Estimated Blood loss)</measure>
    <time_frame>The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.</time_frame>
    <description>Descriptive Statistics on contrast Estimated Blood loss (ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural/in-hospital evaluations (procedure time)</measure>
    <time_frame>The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.</time_frame>
    <description>Descriptive Statistics on procedure time (min); time to hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural/in-hospital evaluations (time to hospital discharge)</measure>
    <time_frame>The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.</time_frame>
    <description>Descriptive Statistics on time to hospital discharge (days).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Aortic Aneurysm, Abdominal</condition>
  <condition>Aortic Aneurysm, Thoracoabdominal</condition>
  <arm_group>
    <arm_group_label>treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantation of the Bifurcated Multilayer Flow Modulator</intervention_name>
    <arm_group_label>treatment</arm_group_label>
    <other_name>BMFM</other_name>
    <other_name>BMFM kit</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must meet ALL of the following criteria:&#xD;
&#xD;
          -  Age over 18&#xD;
&#xD;
          -  Life expectancy &gt; 12 months&#xD;
&#xD;
          -  Aortic aneurysms involving iliac arteries&#xD;
&#xD;
          -  Healthy proximal and distal landing zone&#xD;
&#xD;
          -  Adequate arterial access&#xD;
&#xD;
          -  Healthy branches and collaterals (no stenosis or previously treated by angioplasty)&#xD;
&#xD;
          -  Informed consent understood, signed and patient agrees to all follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if ANY of the following conditions apply:&#xD;
&#xD;
          -  Aneurysm rupture, impending or contained rupture&#xD;
&#xD;
          -  Aortic dissection&#xD;
&#xD;
          -  Aortic root aneurysm&#xD;
&#xD;
          -  Pleural effusion&#xD;
&#xD;
          -  Prior all surgical procedure within 30 days unless procedure is in preparation for&#xD;
             device implantation or planned within 30 days post stent deployment&#xD;
&#xD;
          -  Myocardial infarction or cerebral vascular accident within 6 weeks of treatment&#xD;
&#xD;
          -  Presence/suspicion of connective tissue disorders, for example, Marfan or&#xD;
             Ehlers-Danlos etc.&#xD;
&#xD;
          -  Contraindications to the anticoagulant or/ and antiplatelet medications&#xD;
&#xD;
          -  Allergic reaction to a contrast agent&#xD;
&#xD;
          -  Patient with undergoing or planned chemotherapy&#xD;
&#xD;
          -  History of bleeding disorder (coagulopathy) or thrombophilia&#xD;
&#xD;
          -  Shaggy aorta&#xD;
&#xD;
          -  Takayasu's arteritis&#xD;
&#xD;
          -  Presence/suspicion of infection (for example: mycotic aorta)&#xD;
&#xD;
          -  The use of the MFM® with stent-grafts or previously implanted stent-grafts&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Patients included in another clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpitaux IRIS Sud Molière Longchamps</name>
      <address>
        <city>Bruxelles</city>
        <state>Uccle</state>
        <zip>1190</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Hospital Clinic</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMC Coeur et Vaisseaux</name>
      <address>
        <city>Sale</city>
        <zip>11150</zip>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ELYTIS Hospital: Spital Multidisciplinar şi Policlinică</name>
      <address>
        <city>Iaşi</city>
        <zip>700010</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>European Hospital Polisano</name>
      <address>
        <city>Sibiu</city>
        <zip>550172</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Centre Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maribor University Medical Centre</name>
      <address>
        <city>Maribor</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Morocco</country>
    <country>Romania</country>
    <country>Slovenia</country>
  </location_countries>
  <removed_countries>
    <country>Italy</country>
  </removed_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>March 22, 2018</last_update_submitted>
  <last_update_submitted_qc>March 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>aortic aneurysm involving iliac arteries</keyword>
  <keyword>abdominal aortic aneurysm</keyword>
  <keyword>MFM</keyword>
  <keyword>Multilayer Flow Modulator</keyword>
  <keyword>Multilayer Stent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
    <mesh_term>Aortic Aneurysm, Thoracoabdominal</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/NCT03024554
org study id: 12-2013
nct id: NCT03024554
lead sponsor: 
has dmc: Yes
To determine the safety and efficacy of the BMFM® kit in the use for the endovascular
      treatment of aortic aneurysms involving iliac arteries. The BMFM® kit is an adaptation of the
      aortic MFM® to the aortoiliac bifurcation morphology. It should be noted that the aortic MFM®
      has CE mark approval for the aortic aneurysm treatment.
Endovascular approaches to TAAAs have evolved during the past decade. The initial experiences
      with fenestrated and branched endografts have shown that total endovascular repair is
      effective and may reduce morbidity rates in patients with arch, thoracoabdominal and
      pararenal aneurysms.

      The Cleveland Clinic group has recently reported on their updated clinical experience with
      the first 633 patients treated by fenestrated and branched endografts. Operative mortality
      was 1.8% for pararenal, 5.2% for types I to III, and 2.3% for type IV TAAAs .

      However, 30-40% of TAAA patients remain unsuitable for EVAR due to unfavorable proximal neck
      anatomy. There is also an increased incidence of type I proximal endoleak when established
      f-EVAR guidelines are disregarded, often leading to endovascular re-intervention or surgical
      conversion.

      Currently, the use of the bifurcated stent-graft for the infrarenal aneurysm involving iliac
      arteries treatment has received wide distribution. The application of endovascular technology
      to treat infrarenal aneurysm is now commonplace because the implantation of an infrarenal
      endoprosthesis is a relatively simple procedure requiring adequately long proximal seal zone,
      diameter measurements and accurate longitudinal device placement. However, designing and
      implanting a device, which will accommodate the visceral branches, is more complex.

      The infrarenal with unfavorable or insufficient proximal neck as well as juxtarenal
      aneurysms, which involve iliac arteries, could be treated by combination of the Fenestrated
      Stent Graft with the Bifurcated Stent Graft.

      The principal limitation of this technology is the customized nature of fenestrated
      stent-graft design. From planning to delivery, the process may take in excess of 6 weeks,
      which restricts the application of f-EVAR to stable elective patients. This procedure is
      complex, costly and the implantation time is quite long. It must be conducted in expert
      centers with sophisticated infrastructure (hybrid room). Preservation of visceral aortic
      branches requires precise graft construction and deployment.

      There are reports in the literature of emergent f-EVAR, but the success of these procedures
      relies on on-site modification of commercially available endografts.

      Until an "off-the-shelf'' device is designed to be compatible with the majority of patients,
      ''off-label'' surgeon-modified devices remain the only option in emergencies when open repair
      is prohibited. The "off-the-shelf" devices are likely to allow treatment of more than 60% to
      80% of patients with complex aneurysms but these standardized designs have not yet been
      tested clinically in large number of patients with long follow-up In the absence of widely
      available endografts designs, a number of centers have reported creative techniques to
      incorporate the visceral arteries, such as "chimney", "sandwich" , "octopus" , "periscope"
      and physician-modified endografts. However, these approaches are limited by off-label
      indications, lack of quality control, violation of basic engineering concepts and
      questionable durability.

      One of the drawbacks linked to the use of parallel endografts (mainly for the "chimney
      technique") remains the imperfect seal inherent to this technique. This side by side
      configuration leads to gutter along the parallel endografts, which can result in type I
      endoleaks between the main body of the graft and branched grafts; "Gutter endoleaks"
      continuously pressurize the aneurysm. The gutters between the main aortic graft, the chimney
      graft (GC), and the aortic wall should be as narrow as possible to avoid endoleaks, which can
      be harmful and -almost always- require re-intervention.

      Thoraco Abdominal Aneurysms involving iliac arteries remain a challenge for EVAR. Dilatation
      of the common iliac artery (CIA) often leaves no distal landing zone for commercially
      available stent grafts, which have a maximum diameter of 28 mm. Furthermore, aneurysms
      extended to the internal iliac artery (IIA) make endovascular repair even more difficult.

      A common method allowing endovascular treatment of these aneurysms is occlusion of the IIA,
      thereby creating a distal landing zone in the external iliac artery (EIA). However,
      sacrificing the pelvic blood flow while occluding the internal iliac artery often results in
      buttock claudication and impotence, as well as other complications such as colonic
      infarction, gut or spinal cord ischemia. The frequency of these complications varies between
      13% and 55% and they can impair quality of life substantially.

      Successful treatment of aortoiliac aneurysms involves branch vessel preservation and
      long-term protection from rupture. While EVAR has totally eclipsed open surgery because of
      its lower mortality and morbidities, the durability of EVAR can be questioned because of the
      need for re-intervention and incidence of late aneurysm-related complications . Notably,
      long-term failure can arise because of the loss of proper seal at the proximal or distal
      landing zone of the stent-graft (type I endoleaks). Importantly, common iliac diameter can be
      considered as a predictor of late sac enlargement, as well as implantation outside
      Manufacturer's Instructions For Use (IFU). Furthermore, Benharash et al. managed to
      demonstrate that iliac fixation is of high importance for the prevention of device migration,
      regardless of proximal attachment type.

      Iliac artery involvement incidence in abdominal aortic aneurysms (AAAs) is estimated at 20 to
      30 %. Hence, nearly a third of all patients presenting with AAAs for repair might not fit
      within the IFU for standard EVAR device based on iliac diameters. A common approach to ensure
      appropriate landing zone for iliac components of endografts involves extension into the
      external iliac artery, with or without concomitant hypogastric artery embolization and
      coverage. While unilateral coiling has been demonstrated to have relatively low rates of
      complication, occlusion of the hypogastric artery due to stent graft placement can lead to
      major complications, as mentioned above. Given the significant morbidity associated with
      these complications, industry has developed branch technology for hypogastric preservation.

      The Multilayer Flow Modulator (MFM®) provides a less complex interventional approach for
      aortic aneurysm treatment. This device is an uncovered, self-expanding wire mesh with high
      radial force and flexibility. It is designed to modulate blood-flow dynamics by relieving
      local peak wall shear stress (PWSS), achieving stabilization of aneurysm-sac or false lumen
      pressure and preserving side-branch patency.

      The clinical benefits of this technology have been assessed and shown in case reports and
      clinical studies of thoracoabdominal aneurysm, type B dissection, pararenal aortic aneurysm
      and peripheral artery aneurysm (celiac, hepatic, renal, iliac, subclavian) (48-79). Also the
      prospective multicenter registry of peripheral and visceral aneurysms (69) and the
      prospective multicenter STRATO Trial of TAAA (78), show good results at 12-month follow-up.

      The MFM® eliminates flow vortex pressure and laminates the outside the device along the
      aneurysm wall in the same direction of the blood stream. Laminated flow possess unique and
      protective effects on endothelial cells as well as the ability to promote thrombus
      progressive formation within the aneurysmal sac. The MFM® addresses not only those issues in
      a very unique fashion, providing a uniform interface between the artery wall and the blood
      flow, but its favorable compliance means the device will not be subjected to the same drag
      forces a conventional stent graft will undergo..

      Laminating the blood flow within the aneurysm, promoting thrombus formation within the
      aneurysmal sac and re-establishing a favorable biochemical and biomechanical balance of
      endothelial homeostasis, the MFM® addresses aneurysm related issues and outcomes in a novel
      manner. With aneurysmal stabilization and thrombosis, the MFM® excludes the aneurysm from the
      circulation rather physically and physiologically than mechanically, as other conventional
      grafts do. Thanks to the intrinsic porosity of the device, branches are kept patent and well
      perfused, thus abolishing the risk for collaterals occlusion and consequent ischemia.

      STREAMLINER study is an international, multicentre, prospective, non-randomized study. It is
      designed to evaluate the safety and efficacy of BMFM® kit use. Approximately 40 patients,
      from up to 12 centres in Europe, Israel, Morocco, Bahrain and Turkey, will be enrolled and
      screened per the protocol-required inclusion, exclusion criteria, in order to obtain 30
      completed patients. The results will be compared with published results for other treatment
      modalities in the literature. Patients will be included only after obtaining fully informed
      consent, after conducting all pre-operative examinations required, with respect for all
      inclusion and exclusion criteria. For early demonstration of efficacy and safety an interim
      analysis will be performed after the 10 first enrolled patients will complete their 6 months
      follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with unruptured aneurysm
time frame: 12 months
description: the prevention of aortic aneurysm rupture by the BMFM, in stabilizing it, will be evaluated with the number of patient presenting with unruptured aneurysm at the specified timepoint.
measure: Mortality 30 days, 6 months and 1 year aneurysm-related
time frame: 30 days, 6 months and 12 months
measure: Number of branches and collaterals patent
time frame: 12 months
description: The patency of branches will be evaluated as follows: the number of branches patent will be evaluated on the total number of branches covered by the device (baseline data)
measure: Mortality 30 days, 6 months and 1 year not aneurysm-related
time frame: 30 days, 6 months and 12 months
measure: Number of Major Adverse Events
time frame: 12 months
description: Number of patients with Major Adverse Evens
measure: Technical success
time frame: The technical success is evaluated/recorded post-procedure and presented in the 12 months report.
description: successful delivery and deployment of the BMFM® kit
measure: Procedural/in-hospital evaluations (Anesthesia time)
time frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.
description: descriptive statistics on Anesthesia time (min)
measure: Procedural/in-hospital evaluations (Fluoroscopy time)
time frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.
description: Descriptive Statistics on fluoroscopy time (min)procedure time; time to hospital discharge
measure: Procedural/in-hospital evaluations (Constrast Volume)
time frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.
description: Descriptive Statistics on contrast product volume (ml)
measure: Procedural/in-hospital evaluations (Estimated Blood loss)
time frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.
description: Descriptive Statistics on contrast Estimated Blood loss (ml)
measure: Procedural/in-hospital evaluations (procedure time)
time frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.
description: Descriptive Statistics on procedure time (min); time to hospital discharge
measure: Procedural/in-hospital evaluations (time to hospital discharge)
time frame: The Procedural/in-hospital evaluation are recorded during hospital stay and collected data is presented in the 12 months report.
description: Descriptive Statistics on time to hospital discharge (days).
arm group label: treatment
arm group type: Experimental
description: aortic aneurysm involving iliac arteries treatment with the Bifurcated Multilayer Flow Modulator (BMFM)
intervention type: Device
intervention name: Implantation of the Bifurcated Multilayer Flow Modulator
arm group label: treatment
other name: BMFM
other name: BMFM kit
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Bulgaria
country: Morocco
country: Romania
country: Slovenia
country: Italy
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal
mesh term: Aortic Aneurysm, Thoracoabdominal
sharing ipd: No