<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/NCT02211716</url>
  </required_header>
  <id_info>
    <org_study_id>FMRP-131216</org_study_id>
    <nct_id>NCT02211716</nct_id>
  </id_info>
  <brief_title>Physician-Initiated Trial Investigating the BeGraft Peripheral Stent Graft System</brief_title>
  <official_title>Physician-Initiated PMCF Trial Investigating the BeGraft Peripheral Stent Graft System for the Treatment of Iliac Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Flanders Medical Research Program</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Flanders Medical Research Program</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this clinical investigation is to evaluate, in a controlled setting, the&#xD;
      long-term (up to 12 months) safety and efficacy of the BeGraft Peripheral Stent Graft System&#xD;
      (Bentley InnoMed) in clincial settings post CE-certification when used according to the&#xD;
      indications of the IFU.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endovascular techniques are well accepted in the treatment of iliac occlusive disease. It is&#xD;
      shown that in the iliac artery especially stenoses and short occlusions respond well to&#xD;
      percutaneous transluminal angioplasty (PTA) with our without stenting. Although hard data are&#xD;
      lacking, with the technical developments and the introduction of new stent types, more&#xD;
      complex lesions have been treated with endovascular procedures. Although stents are often&#xD;
      used to improve the outcome of PTA, there is no general consensus whether stenting is&#xD;
      mandatory for chronic iliac arterial occlusion. The more, if we use stents, it is still&#xD;
      unclear if we should implant bare self-expandable stents, bare balloon-expandable stents or&#xD;
      covered stents. On one hand, the randomized controlled Dutch Iliac Stenting trial failed in&#xD;
      demonstrating superiority of primary stenting over PTA with additional stenting in short&#xD;
      lesions. On the other hand, while several papers advocate bare stenting, other trials&#xD;
      conclude better results with covered stents.&#xD;
&#xD;
      The Trans-Atlantic Inter-Society Consensus (TASC) working group has published in 2000 their&#xD;
      recommendations for the management of peripheral arterial disease. In order to better reflect&#xD;
      the developments in technology and techniques, the TASC working group has revised and updated&#xD;
      their recommendations in the TASC-II document in 2007.&#xD;
&#xD;
      The treatment recommendations between surgical or percutaneous intervention they propose&#xD;
      involve all peripheral arterial beds and are based upon several factors such as availability&#xD;
      of expertise in the percutaneous or conventional vascular surgical techniques, the patient's&#xD;
      preference and most importantly on the lesion's morphology. TASC classifies all lesions in&#xD;
      the different beds into types A to D. In general, endovascular therapy is the treatment of&#xD;
      choice for TASC A &amp; B-lesions and surgery is preferred for good-risk patients with TASC C&#xD;
      lesions and all TASC D lesions.&#xD;
&#xD;
      For aorto-iliac lesions, the TASC-II classification is as follows:&#xD;
&#xD;
      Type A lesions&#xD;
&#xD;
        1. Unilateral or bilateral stenoses of the Common Iliac Artery (CIA).&#xD;
&#xD;
        2. Unilateral or bilateral single short (≤3 cm) stenosis of the External Iliac Artery&#xD;
           (EIA).&#xD;
&#xD;
      Type B lesions&#xD;
&#xD;
        1. Short (≤3 cm) stenosis of infrarenal aorta.&#xD;
&#xD;
        2. Unilateral CIA occlusion.&#xD;
&#xD;
        3. Single or multiple stenosis totaling 3-10 cm involving the EIA not extending into the&#xD;
           Common Femoral Artery (CFA)&#xD;
&#xD;
        4. Unilateral EIA occlusion not involving the origins of Internal Iliac Artery (IIA) or CFA&#xD;
           Type C lesions&#xD;
&#xD;
      1. Bilateral CIA occlusions 2. Bilateral EIA stenoses 3-10 cm long not extending into the CFA&#xD;
      3. Unilateral EIA stenosis extending into the CFA 4. Unilateral EIA occlusion that involves&#xD;
      the origins of IIA and/or CFA 5. Heavily calcified unilateral EIA occlusion with or without&#xD;
      involvement of origins of IIA and/or CFA Type D lesions&#xD;
&#xD;
        1. Infra-renal aortoiliac occlusion&#xD;
&#xD;
        2. Diffuse disease involving the aorta and both iliac arteries requiring treatment&#xD;
&#xD;
        3. Diffuse multiple stenoses involving the unilateral CIA, EIA and CFA&#xD;
&#xD;
        4. Unilateral occlusions of both CIA and EIA&#xD;
&#xD;
        5. Bilateral occlusions of EIA&#xD;
&#xD;
        6. Iliac stenoses in patients with an Abdominal Aortic Aneurysm (AAA) requiring treatment&#xD;
           and not amenable to endograft placement or other lesions requiring open aortic or iliac&#xD;
           surgery&#xD;
&#xD;
      The TASC working group has based their recommendations on the literature available to date&#xD;
      and are generally considered as the guidelines to be followed. Nevertheless it should be&#xD;
      stated that it is feasible to treat with good technical success and sustained durability TASC&#xD;
      type C and D lesions in an endovascular way.&#xD;
&#xD;
      Recent publications finally start to show the excellent durability of iliac stenting in the&#xD;
      daily practice. Park et al, described their long term (up to 10 years) experience in their&#xD;
      total cohort of iliac patients (TASC type A-D lesions) and presented impressive primary&#xD;
      patency rates of 87%, 83%, 61% and 49% at respectively 3, 5, 7 and 10 years after the index&#xD;
      intervention. De Roeck et al. published their results after stenting of different types of&#xD;
      iliac occlusions (TASC type B-D), and showed primary patency rates of 94%, 89% and 77% after&#xD;
      respectively 1, 3 and 5 years follow up. They could also show that in their cohort of&#xD;
      patients with complex aorto-iliac lesions, stent-failures can always be endovascularly&#xD;
      rescued. They showed secondary patency rates of 100% after 1 year and 94% after both 3 and 5&#xD;
      years. Bosiers et al. concluded in their BRAVISSIMO trial primary patency rates at 12 months&#xD;
      for the TASC A, B, C and D lesions of respectively 94.0%, 96.5%, 91.3% and 90.2%. Leville et&#xD;
      al. questioned after the presentation of their outcome with stenting iliac occlusion (primary&#xD;
      patency rate of 76% and secondary patency rate of 90% after 3 years), whether the&#xD;
      endovascular treatment for iliac occlusive disease should be extended to Type C and D&#xD;
      lesions. Leville came to this conclusion as they could not detect any significant differences&#xD;
      in outcome for both primary and secondary patency rates stratifying for the TASC&#xD;
      classifications. They summarized the treatment of iliac artery occlusion can be accomplished&#xD;
      via endovascular means with little morbidity and acceptable patency rates. The COBEST trial&#xD;
      demonstrates that covered and bare-metal stents produce similar and acceptable results for&#xD;
      TASC B lesions. However, covered stents perform better for TASC C and D lesions than bare&#xD;
      stents in longer-term patency and clinical outcome. Sabri et al. concluded that the use of&#xD;
      covered balloon-expandable kissing stents for atherosclerotic aortic bifurcation occlusive&#xD;
      disease provides superior patency at 2 years as compared with bare metal balloon-expandable&#xD;
      stents. Bosiers et al. experienced that the implantation of the Advanta V12 PTFE-covered&#xD;
      stent for iliac occlusive disease shows to be safe and feasible with excellent clinical&#xD;
      results at 1 year in the investigated patient cohort. The TASC stratification is an important&#xD;
      tool in allowing us to assess the extent of lesion morphology, but extensive lesions do not&#xD;
      preclude successful endovascular treatment. They continued that the fate of the limb is&#xD;
      dictated by the infrainguinal disease that is often present in patients with complex iliac&#xD;
      occlusions and therefore believe that endovascular attempts should be exhausted before&#xD;
      attempting open surgical repair of iliac occlusions because of the decreased perioperative&#xD;
      morbidity and good mid-term durability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 4</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>Primary patency at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (&gt;50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary patency rate at 1- and 6-month follow-up</measure>
    <time_frame>1 and 6 months</time_frame>
    <description>Patients that present wihout a hemodynamically significant stenosis at the target area on duplex ultrasound (&gt;50%, systolic velocity ratio no greater than 2.4) and without prior TLR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent graft occlusion rate at pre-discharge, 1-, 6- and 12-month follow-up</measure>
    <time_frame>1 day post-op, 1, 6 and 12 months</time_frame>
    <description>The ratio of patients where the implanted stent graft has been occluded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle Brachial Index (ABI) at 1-, 6- and 12-month follow-up</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>The ABI measurement at 1, 6 and 12 months compared to the baseline ABI measurement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance success rate at baseline</measure>
    <time_frame>1 day post-op</time_frame>
    <description>Defined as a composite of:&#xD;
successful in sealing acute perforation or rupture&#xD;
successful in treating aneurysms and fistulae&#xD;
restoration of blood flow</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-stent restenosis rate at 1-, 6- and 12-month follow-up</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>The ratio of patients experiencing in-stent restenosis at the different follow-ups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from Target Lesion Revascularization (TLR) at 1-, 6- and 12-months</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>Defined as freedom from a repeat intervention to maintain or re-estabish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Avents</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>1 day post-op</time_frame>
    <description>Defined as the ability to achieve final residual angiographic stenosis no greater than 30%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amputation rate at 1-, 6- and 12-month follow-up</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>Defined as any amputation above the knee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success at 1-, 6- and 12-month follow-up</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>Defined as an improvement of Rutherford classification at 1-, 6- and 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Peripheral Vascular Disease</condition>
  <arm_group>
    <arm_group_label>BeGraft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient's treated with the BeGraft PMCF Stent Graft System from Bentley Innomed for the treatment of iliac lesions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BeGraft Peripheral Stent Graft System</intervention_name>
    <arm_group_label>BeGraft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. General Inclusion criteria&#xD;
&#xD;
               -  Corresponding to the CE-mark indications/contra-indications and according to the&#xD;
                  current medical guidelines for minimally invasive peripheral interventions.&#xD;
&#xD;
               -  Patient presenting with a stenotic or occlusive lesion at the iliac arteries&#xD;
                  suitable for stenting (on indication for primary stenting, based on the&#xD;
                  discretion of the investigator)&#xD;
&#xD;
               -  Patient presenting a score from 2 to 5 following Rutherford classification&#xD;
&#xD;
               -  Patient is willing to comply with specified follow-up evaluations at the&#xD;
                  specified times for the duration of the study&#xD;
&#xD;
               -  Patient is &gt;18 years old&#xD;
&#xD;
               -  Patient (or their legal representative) understands the nature of the procedure&#xD;
                  and provides written informed consent, prior to enrolment in the study&#xD;
&#xD;
               -  Patient is eligible for treatment with the BeGraft Peripheral Stent Graft System&#xD;
                  (Bentley InnoMed)&#xD;
&#xD;
          2. Angiographic Inclusion Criteria&#xD;
&#xD;
               -  The target lesion is either a modified TASC-II class A, B, C or D lesion with one&#xD;
                  of the listed specifications:&#xD;
&#xD;
                    -  Type A lesions&#xD;
&#xD;
                         -  Unilateral or bilateral stenoses of the Common Iliac Artery&#xD;
&#xD;
                         -  Unilateral or bilateral single short (≤3 cm) stenosis of the External&#xD;
                            Iliac Artery&#xD;
&#xD;
                    -  Type B lesions&#xD;
&#xD;
                         -  Unilateral Common Iliac Artery occlusion&#xD;
&#xD;
                         -  Single or multiple stenosis totaling 3-10 cm involving the External&#xD;
                            Iliac Artery not extending into the Common Femoral Artery&#xD;
&#xD;
                         -  Unilateral External Iliac Artery occlusion not involving the origins of&#xD;
                            Internal Iliac Artery or Common Iliac Artery&#xD;
&#xD;
                    -  Type C lesions&#xD;
&#xD;
                         -  Bilateral Common Iliac Artery occlusions&#xD;
&#xD;
                         -  Bilateral External Iliac Artery stenoses 3-10 cm long not extending&#xD;
                            into the Common Femoral Artery&#xD;
&#xD;
                    -  Type D lesions&#xD;
&#xD;
                         -  Unilateral occlusions of both Common Iliac and External Iliac Artery&#xD;
&#xD;
                         -  Diffuse disease involving the aorta and both iliac arteries requiring&#xD;
                            treatment&#xD;
&#xD;
                         -  Bilateral occlusions of External Iliac Artery&#xD;
&#xD;
               -  The target lesion has angiographic evidence of stenosis or restenosis &gt; 50% or&#xD;
                  occlusion which can be passed with standard guidewire manipulation&#xD;
&#xD;
               -  There is angiographic evidence of a patent Common an Deep Femoral Artery&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  PTA is technically not possible (not feasible to access the lesion or a defect with&#xD;
             the guidewire or balloon catheter)&#xD;
&#xD;
          -  Presence of an aneurysm immediately adjacent to the site of stent implantation&#xD;
&#xD;
          -  Stenosis distal to the site of stent implantation&#xD;
&#xD;
          -  Lesions in or adjacent to essential collateral(s)&#xD;
&#xD;
          -  Lesions in locations subject to external compression&#xD;
&#xD;
          -  Heavily calcified lesions resistant to PTA&#xD;
&#xD;
          -  Patients with diffuse distal disease resulting in poor stent outflow&#xD;
&#xD;
          -  Patients with a history of coagulation disorders&#xD;
&#xD;
          -  Patients with aspirin allergy or bleeding complications and patients unable or&#xD;
             unwilling to tolerate anticoagulant/antiplatelet therapy and/or non-responders to&#xD;
             anticoagulant/antiplatelet therapy&#xD;
&#xD;
          -  Fresh thrombus formation&#xD;
&#xD;
          -  Patients with known hypersensitivity to the stent material (L605) and/or PTFE&#xD;
&#xD;
          -  The target lesion is either a modified TASC-II class B or D lesion with aortic or&#xD;
             common femoral lesion involvement:&#xD;
&#xD;
               -  Type B lesions&#xD;
&#xD;
                    -  Short (≤3 cm) stenosis of infrarenal aorta&#xD;
&#xD;
               -  Type C lesions&#xD;
&#xD;
                    -  Unilateral External Iliac Artery stenosis extending into the Common Femoral&#xD;
                       Artery&#xD;
&#xD;
                    -  Unilateral External Iliac Artery occlusion that involves the origins of the&#xD;
                       Internal Iliac and/or Common Femoral Artery&#xD;
&#xD;
                    -  Heavily calcified unilateral External Iliac Artery occlusion with or without&#xD;
                       involvement of origins of the Internal Iliac and/or Common Femoral Artery&#xD;
&#xD;
               -  Type D lesions&#xD;
&#xD;
                    -  Infra-renal aortoiliac occlusion&#xD;
&#xD;
                    -  Iliac stenoses in patients with an Abdominal Aortic Aneurysm (AAA) requiring&#xD;
                       treatment and not amenable to endograft placement or other lesions requiring&#xD;
                       open aortic or iliac surgery&#xD;
&#xD;
                    -  Diffuse multiple stenoses involving the unilateral Common Iliac, External&#xD;
                       Iliac and Common Femoral Artery&#xD;
&#xD;
          -  Previously implanted stent(s) at the same lesion site&#xD;
&#xD;
          -  Reference segment diameter is not suitable for the available stent design&#xD;
&#xD;
          -  Untreatable lesion located at the distal outflow arteries&#xD;
&#xD;
          -  Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation&#xD;
             therapy) as part of the index procedure&#xD;
&#xD;
          -  Patients refusing treatment&#xD;
&#xD;
          -  Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are&#xD;
             contraindicated&#xD;
&#xD;
          -  Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion&#xD;
             site&#xD;
&#xD;
          -  Perforation at the angioplasty site evidenced by extravasation of contrast medium&#xD;
&#xD;
          -  Patients with a history of prior life-threatening contrast medium reaction&#xD;
&#xD;
          -  Patients with uncorrected bleeding disorders&#xD;
&#xD;
          -  Female patient with child bearing potential not taking adequate contraceptives or&#xD;
             currently breastfeeding&#xD;
&#xD;
          -  Life expectancy of less than twelve months&#xD;
&#xD;
          -  Any planned surgical intervention/procedure within 30 days of the study procedure&#xD;
&#xD;
          -  Any patient considered to be hemodynamically unstable at onset of procedure&#xD;
&#xD;
          -  Patient is currently participating in another investigational drug or device study&#xD;
             that has not completed the entire follow up period&#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>Koen Deloose, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Flanders Medical Research Program</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OLV Hospital</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imelda Hospital</name>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Blasius</name>
      <address>
        <city>Dendermonde</city>
        <zip>9200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RZ Heilig Hart Tienen</name>
      <address>
        <city>Tienen</city>
        <zip>3300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02211716
org study id: FMRP-131216
nct id: NCT02211716
lead sponsor: 
has dmc: Yes
The objective of this clinical investigation is to evaluate, in a controlled setting, the
      long-term (up to 12 months) safety and efficacy of the BeGraft Peripheral Stent Graft System
      (Bentley InnoMed) in clincial settings post CE-certification when used according to the
      indications of the IFU.
Endovascular techniques are well accepted in the treatment of iliac occlusive disease. It is
      shown that in the iliac artery especially stenoses and short occlusions respond well to
      percutaneous transluminal angioplasty (PTA) with our without stenting. Although hard data are
      lacking, with the technical developments and the introduction of new stent types, more
      complex lesions have been treated with endovascular procedures. Although stents are often
      used to improve the outcome of PTA, there is no general consensus whether stenting is
      mandatory for chronic iliac arterial occlusion. The more, if we use stents, it is still
      unclear if we should implant bare self-expandable stents, bare balloon-expandable stents or
      covered stents. On one hand, the randomized controlled Dutch Iliac Stenting trial failed in
      demonstrating superiority of primary stenting over PTA with additional stenting in short
      lesions. On the other hand, while several papers advocate bare stenting, other trials
      conclude better results with covered stents.

      The Trans-Atlantic Inter-Society Consensus (TASC) working group has published in 2000 their
      recommendations for the management of peripheral arterial disease. In order to better reflect
      the developments in technology and techniques, the TASC working group has revised and updated
      their recommendations in the TASC-II document in 2007.

      The treatment recommendations between surgical or percutaneous intervention they propose
      involve all peripheral arterial beds and are based upon several factors such as availability
      of expertise in the percutaneous or conventional vascular surgical techniques, the patient's
      preference and most importantly on the lesion's morphology. TASC classifies all lesions in
      the different beds into types A to D. In general, endovascular therapy is the treatment of
      choice for TASC A & B-lesions and surgery is preferred for good-risk patients with TASC C
      lesions and all TASC D lesions.

      For aorto-iliac lesions, the TASC-II classification is as follows:

      Type A lesions

        1. Unilateral or bilateral stenoses of the Common Iliac Artery (CIA).

        2. Unilateral or bilateral single short (≤3 cm) stenosis of the External Iliac Artery
           (EIA).

      Type B lesions

        1. Short (≤3 cm) stenosis of infrarenal aorta.

        2. Unilateral CIA occlusion.

        3. Single or multiple stenosis totaling 3-10 cm involving the EIA not extending into the
           Common Femoral Artery (CFA)

        4. Unilateral EIA occlusion not involving the origins of Internal Iliac Artery (IIA) or CFA
           Type C lesions

      1. Bilateral CIA occlusions 2. Bilateral EIA stenoses 3-10 cm long not extending into the CFA
      3. Unilateral EIA stenosis extending into the CFA 4. Unilateral EIA occlusion that involves
      the origins of IIA and/or CFA 5. Heavily calcified unilateral EIA occlusion with or without
      involvement of origins of IIA and/or CFA Type D lesions

        1. Infra-renal aortoiliac occlusion

        2. Diffuse disease involving the aorta and both iliac arteries requiring treatment

        3. Diffuse multiple stenoses involving the unilateral CIA, EIA and CFA

        4. Unilateral occlusions of both CIA and EIA

        5. Bilateral occlusions of EIA

        6. Iliac stenoses in patients with an Abdominal Aortic Aneurysm (AAA) requiring treatment
           and not amenable to endograft placement or other lesions requiring open aortic or iliac
           surgery

      The TASC working group has based their recommendations on the literature available to date
      and are generally considered as the guidelines to be followed. Nevertheless it should be
      stated that it is feasible to treat with good technical success and sustained durability TASC
      type C and D lesions in an endovascular way.

      Recent publications finally start to show the excellent durability of iliac stenting in the
      daily practice. Park et al, described their long term (up to 10 years) experience in their
      total cohort of iliac patients (TASC type A-D lesions) and presented impressive primary
      patency rates of 87%, 83%, 61% and 49% at respectively 3, 5, 7 and 10 years after the index
      intervention. De Roeck et al. published their results after stenting of different types of
      iliac occlusions (TASC type B-D), and showed primary patency rates of 94%, 89% and 77% after
      respectively 1, 3 and 5 years follow up. They could also show that in their cohort of
      patients with complex aorto-iliac lesions, stent-failures can always be endovascularly
      rescued. They showed secondary patency rates of 100% after 1 year and 94% after both 3 and 5
      years. Bosiers et al. concluded in their BRAVISSIMO trial primary patency rates at 12 months
      for the TASC A, B, C and D lesions of respectively 94.0%, 96.5%, 91.3% and 90.2%. Leville et
      al. questioned after the presentation of their outcome with stenting iliac occlusion (primary
      patency rate of 76% and secondary patency rate of 90% after 3 years), whether the
      endovascular treatment for iliac occlusive disease should be extended to Type C and D
      lesions. Leville came to this conclusion as they could not detect any significant differences
      in outcome for both primary and secondary patency rates stratifying for the TASC
      classifications. They summarized the treatment of iliac artery occlusion can be accomplished
      via endovascular means with little morbidity and acceptable patency rates. The COBEST trial
      demonstrates that covered and bare-metal stents produce similar and acceptable results for
      TASC B lesions. However, covered stents perform better for TASC C and D lesions than bare
      stents in longer-term patency and clinical outcome. Sabri et al. concluded that the use of
      covered balloon-expandable kissing stents for atherosclerotic aortic bifurcation occlusive
      disease provides superior patency at 2 years as compared with bare metal balloon-expandable
      stents. Bosiers et al. experienced that the implantation of the Advanta V12 PTFE-covered
      stent for iliac occlusive disease shows to be safe and feasible with excellent clinical
      results at 1 year in the investigated patient cohort. The TASC stratification is an important
      tool in allowing us to assess the extent of lesion morphology, but extensive lesions do not
      preclude successful endovascular treatment. They continued that the fate of the limb is
      dictated by the infrainguinal disease that is often present in patients with complex iliac
      occlusions and therefore believe that endovascular attempts should be exhausted before
      attempting open surgical repair of iliac occlusions because of the decreased perioperative
      morbidity and good mid-term durability.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary patency at 12 months
time frame: 12 months
description: Defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months.
measure: Primary patency rate at 1- and 6-month follow-up
time frame: 1 and 6 months
description: Patients that present wihout a hemodynamically significant stenosis at the target area on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without prior TLR.
measure: Stent graft occlusion rate at pre-discharge, 1-, 6- and 12-month follow-up
time frame: 1 day post-op, 1, 6 and 12 months
description: The ratio of patients where the implanted stent graft has been occluded.
measure: Ankle Brachial Index (ABI) at 1-, 6- and 12-month follow-up
time frame: 1, 6 and 12 months
description: The ABI measurement at 1, 6 and 12 months compared to the baseline ABI measurement.
measure: Performance success rate at baseline
time frame: 1 day post-op
description: Defined as a composite of:
successful in sealing acute perforation or rupture
successful in treating aneurysms and fistulae
restoration of blood flow
measure: In-stent restenosis rate at 1-, 6- and 12-month follow-up
time frame: 1, 6 and 12 months
description: The ratio of patients experiencing in-stent restenosis at the different follow-ups.
measure: Freedom from Target Lesion Revascularization (TLR) at 1-, 6- and 12-months
time frame: 1, 6 and 12 months
description: Defined as freedom from a repeat intervention to maintain or re-estabish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge.
measure: Serious Adverse Avents
time frame: up to 12 months
measure: Technical success
time frame: 1 day post-op
description: Defined as the ability to achieve final residual angiographic stenosis no greater than 30%.
measure: Amputation rate at 1-, 6- and 12-month follow-up
time frame: 1, 6 and 12 months
description: Defined as any amputation above the knee.
measure: Clinical success at 1-, 6- and 12-month follow-up
time frame: 1, 6 and 12 months
description: Defined as an improvement of Rutherford classification at 1-, 6- and 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
arm group label: BeGraft
arm group type: Experimental
description: Patient's treated with the BeGraft PMCF Stent Graft System from Bentley Innomed for the treatment of iliac lesions.
intervention type: Device
intervention name: BeGraft Peripheral Stent Graft System
arm group label: BeGraft
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Koen Deloose, MD
role: Principal Investigator
affiliation: Flanders Medical Research Program
facility: 
facility: 
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Vascular Diseases
mesh term: Peripheral Vascular Diseases
mesh term: Peripheral Arterial Disease
sharing ipd: Undecided