<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/NCT03286361</url>
  </required_header>
  <id_info>
    <org_study_id>ID3-20170711</org_study_id>
    <nct_id>NCT03286361</nct_id>
  </id_info>
  <brief_title>Clinical Trial Investigating the BeGraft Peripheral Plus Stent Graft System for Iliac Lesion Treatment</brief_title>
  <acronym>BeGraft+PMCF</acronym>
  <official_title>Belgo-France Physician-initiated Trial Investigating the BeGraft Peripheral Plus Stent Graft System for the Treatment of Iliac Lesions (TASC A, B, C and D)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ID3 Medical</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ID3 Medical</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The BeGraft Plus PMCF Trial investigates the efficacy of the BeGraft Peripheral Plus Stent&#xD;
      Graft System in the treatment of iliac stenotic or occlusive lesions (TASC A, B, C and D). An&#xD;
      expected total of 20 patients with TASC A and B lesions and an expected total of 50 patients&#xD;
      with TASC C and D lesions will be treated. The lesion is located within the native Iliac&#xD;
      arteries. Prior to stenting with the BeGraft Peripheral Plus Stent Graft System,&#xD;
      pre-dilatation can be performed according to the physician's discretion. Also post-dilatation&#xD;
      can be performed according to the physician's discretion. Patients will be invited for a&#xD;
      follow-up visit at 1, 6, 12, 24 and 36- month post-procedure. The primary efficacy endpoint&#xD;
      of the study is the primary patency at 12 months. The primary safety endpoint is the freedom&#xD;
      of periprocedural Serious Adverse Events (SAEs). Secondary endpoint include primary patency&#xD;
      rate at 1, 6, 24, and 36-month, stent graft occlusion rate at pre-discharge,1, 6, 24, and 36&#xD;
      month follow-up, anke-brachial index (ABI) at 1, 6, 12, 24 and 36-month follow-up, amputation&#xD;
      rate at 1, 6, 12, 24 and 36-month follow-up, performance success rate, freedom from target&#xD;
      lesion revascularization (TLR), technical success and clinical success at 1, 6, 12, 24 and&#xD;
      36-month follow-up. The extension in the Begraft Plus protocol is being made to evaluate the&#xD;
      long-term safety and efficacy of the BeGraft Peripheral Plus Stent Graft.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this clinical investigation is to evaluate, in a controlled setting, the&#xD;
      long-term safety and efficacy of the BeGraft Peripheral Plus Stent Graft System in clinical&#xD;
      settings post CE-certification when used according to the indications of the IFU with focus&#xD;
      on the treatment of complex TASC A, B, C and D iliac lesions.&#xD;
&#xD;
      Patients will be selected based on the investigator's assessment, evaluation of the&#xD;
      underlying disease and the eligibility criteria. The patient's medical condition should be&#xD;
      stable, with no underlying medical condition which would prevent them from performing the&#xD;
      required testing or from completing the study. Patients should also be geographically stable,&#xD;
      willing and able to cooperate in this clinical study and remain available for long-term&#xD;
      follow-up. A patient is considered enrolled in the study after obtaining the patients&#xD;
      informed consent, if there is full compliance with the study eligibility criteria and after&#xD;
      successful guidewire passage through the study target lesion.&#xD;
&#xD;
      Prior to the index procedure the following tests and clinical data will be collected:&#xD;
      informed consent for data collection, demographics, medical history, medication record,&#xD;
      physical examination, clinical category of chronic limb ischemia (Rutherford category) and&#xD;
      resting ankle-brachial index (ABI).&#xD;
&#xD;
      During the procedure, the vascular access can be achieved to the investigator's standard&#xD;
      clinical practice. After successful lesion passage, diagnostic angiography of the lesion area&#xD;
      and distal run-off is performed and angiographic measurements (vessel diameter, percentage&#xD;
      stenosis and lesion length) are collected. At the physician's discretion, the patient&#xD;
      receives at least 1 BeGraft Peripheral Plus Stent Graft System. Pre- and post-dilatation are&#xD;
      according to the physician's discretion. No other adjunctive therapies (atherectomy, laser)&#xD;
      are allowed. The complete iliac vasculature should be treated in one single session, staged&#xD;
      interventions are not allowed. All outflow-limiting lesions must be treated according to the&#xD;
      hospital treatment standard.&#xD;
&#xD;
      The regular follow-ups are necessary to monitor the condition of the patient and the&#xD;
      stent/procedure. Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36 months&#xD;
      after the index procedure. The following data will be collected during these follow-up visit:&#xD;
      medication record, physical examination, rutherford categorization, ABI and color flow&#xD;
      doppler ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 29, 2017</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</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>Primary patency at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Freedom from &gt;50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) &lt;2.5 in the target vessel with no target lesion revascularization within 12 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Periprocedural Serious Adverse Events (SAEs)</measure>
    <time_frame>30-days post-procedure</time_frame>
    <description>Periprocedural SAEs up to 30-days post-procedure, as defined according to the International Organization of Standardization (ISO) guidelines: ISO 14155:2011</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary patency rate</measure>
    <time_frame>1-, 6-, 24- and 36-months post-procedure</time_frame>
    <description>Freedom from &gt;50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) &lt;2.5 in the target vessel with no target lesion revascularization within 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent graft occlusion rate</measure>
    <time_frame>Pre-discharge, 1-, 6- 12-, 24-, and 36-month follow-up</time_frame>
    <description>Occlusion of the stent graft system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle-brachial index (ABI)</measure>
    <time_frame>1-, 6-, 12-, 24-, and 36-month follow-up</time_frame>
    <description>ABI at follow-up compared with the baseline ABI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amputation rate</measure>
    <time_frame>1-, 6-, 12-, 24-, and 36-month follow-up</time_frame>
    <description>Any amputation above the knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance success rate</measure>
    <time_frame>Baseline</time_frame>
    <description>Successful in sealing acute perforation or rupture, in treating aneurysms and fistulae of restoration of blood flow</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from target lesion revascularization (TLR)</measure>
    <time_frame>1-, 6-, 12-, 24-, and 36-month follow-up</time_frame>
    <description>Freedom from a repeated intervention to maintain or re-establish 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>Technical success</measure>
    <time_frame>Index procedure</time_frame>
    <description>Ability to achieve final residual angiographic stenosis no greater than 30%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>1-, 6-, 12-, 24-, and 36-month follow-up</time_frame>
    <description>Improvement of Rutherford classification compared to the pre-procedure Rutherford classification</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>BeGraft Peripheral + Stent Graft System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients treated with the BeGraft Peripheral Plus Stent Graft System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BeGraft Peripheral Plus Stent Graft System</intervention_name>
    <description>Patients will be treated with the BeGraft Peripheral Plus Stent Graft System</description>
    <arm_group_label>BeGraft Peripheral + Stent Graft System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General inclusion criteria&#xD;
&#xD;
          -  Corresponding to the Conformité Européenne (CE)-mark indications/contra-indications&#xD;
             and according to the current medical guidelines for minimally invasive peripheral&#xD;
             interventions.&#xD;
&#xD;
          -  Patient presenting with a stenotic or occlusive lesion at the iliac arteries suitable&#xD;
             for stenting (on indication for primary stenting, based on the discretion of the&#xD;
             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 specified&#xD;
             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 and&#xD;
             provides written informed consent, prior to enrolment in the study&#xD;
&#xD;
          -  Patient is eligible for treatment with the BeGraft Peripheral Plus Stent Graft System&#xD;
             (Bentley)&#xD;
&#xD;
          -  Patient is treated as emergency case (ruptures, perforations, aneurysms and fistulae)&#xD;
&#xD;
        Angiographic inclusion criteria:&#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 and Deep Femoral Artery&#xD;
&#xD;
          -  The target lesion is either a modified TASC-II class A, B, C or D lesion with one of&#xD;
             the listed specifications:&#xD;
&#xD;
             o Type A lesions&#xD;
&#xD;
          -  Unilateral or bilateral stenosis of the Common Iliac Artery&#xD;
&#xD;
          -  Unilateral or bilateral single short (≤3 cm) stenosis of the External Iliac Artery&#xD;
&#xD;
             o Type B lesions&#xD;
&#xD;
          -  Unilateral Common Iliac Artery occlusion&#xD;
&#xD;
          -  Single or multiple stenosis totaling 3-10 cm involving the External Iliac Artery not&#xD;
             extending into the Common Femoral Artery&#xD;
&#xD;
          -  Unilateral External Iliac Artery occlusion not involving the origins of Internal Iliac&#xD;
             Artery or Common Iliac Artery&#xD;
&#xD;
             o Type C lesions&#xD;
&#xD;
          -  Bilateral Common Iliac Artery occlusions&#xD;
&#xD;
          -  Bilateral External Iliac Artery stenoses 3-10 cm long not extending into the Common&#xD;
             Femoral Artery&#xD;
&#xD;
             o Type D lesions&#xD;
&#xD;
          -  Unilateral occlusions of both Common Iliac and External Iliac Artery&#xD;
&#xD;
          -  Diffuse disease involving the aorta bifurcation&#xD;
&#xD;
          -  Bilateral occlusions of External Iliac 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 collaterals(s)&#xD;
&#xD;
          -  Lesions in locations subject to external compression&#xD;
&#xD;
          -  Heavily calcified lesions resistant to percutaneous transluminal angioplasty (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&#xD;
             polytetrafluoroethylene (PTFE)&#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, drug-coated balloon&#xD;
             (DCB), laser, radiation 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;
          -  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;
&#xD;
          -  The target lesion is either a modified TASC-II class B, C or D lesion with aortic or&#xD;
             common femoral lesion involvement:&#xD;
&#xD;
             o Type B lesions&#xD;
&#xD;
          -  Short (≤3 cm) stenosis of infrarenal aorta&#xD;
&#xD;
             o Type C lesions&#xD;
&#xD;
          -  Unilateral External Iliac Artery stenosis extending into the Common Femoral Artery&#xD;
&#xD;
          -  Unilateral External Iliac Artery occlusion that involves the origins of the Internal&#xD;
             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;
             o Type D lesions&#xD;
&#xD;
          -  Infra-renal aortoiliac occlusion&#xD;
&#xD;
          -  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&#xD;
             iliac surgery&#xD;
&#xD;
          -  Diffuse multiple stenoses involving the unilateral Common Iliac, External Iliac and&#xD;
             Common Femoral Artery&#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>Study Director</role>
    <affiliation>ID3 Medical</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>O.L.V. Hospital</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZNA</name>
      <address>
        <city>Antwerpen</city>
        <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>A.Z. Sint-Blasius</name>
      <address>
        <city>Dendermonde</city>
        <zip>9200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZOL</name>
      <address>
        <city>Genk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>az Groeninge</name>
      <address>
        <city>Kortrijk</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RZ Heilig Hart</name>
      <address>
        <city>Tienen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Jan Portaels</name>
      <address>
        <city>Vilvoorde</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</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>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</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/NCT03286361
org study id: ID3-20170711
nct id: NCT03286361
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The BeGraft Plus PMCF Trial investigates the efficacy of the BeGraft Peripheral Plus Stent
      Graft System in the treatment of iliac stenotic or occlusive lesions (TASC A, B, C and D). An
      expected total of 20 patients with TASC A and B lesions and an expected total of 50 patients
      with TASC C and D lesions will be treated. The lesion is located within the native Iliac
      arteries. Prior to stenting with the BeGraft Peripheral Plus Stent Graft System,
      pre-dilatation can be performed according to the physician's discretion. Also post-dilatation
      can be performed according to the physician's discretion. Patients will be invited for a
      follow-up visit at 1, 6, 12, 24 and 36- month post-procedure. The primary efficacy endpoint
      of the study is the primary patency at 12 months. The primary safety endpoint is the freedom
      of periprocedural Serious Adverse Events (SAEs). Secondary endpoint include primary patency
      rate at 1, 6, 24, and 36-month, stent graft occlusion rate at pre-discharge,1, 6, 24, and 36
      month follow-up, anke-brachial index (ABI) at 1, 6, 12, 24 and 36-month follow-up, amputation
      rate at 1, 6, 12, 24 and 36-month follow-up, performance success rate, freedom from target
      lesion revascularization (TLR), technical success and clinical success at 1, 6, 12, 24 and
      36-month follow-up. The extension in the Begraft Plus protocol is being made to evaluate the
      long-term safety and efficacy of the BeGraft Peripheral Plus Stent Graft.
The objective of this clinical investigation is to evaluate, in a controlled setting, the
      long-term safety and efficacy of the BeGraft Peripheral Plus Stent Graft System in clinical
      settings post CE-certification when used according to the indications of the IFU with focus
      on the treatment of complex TASC A, B, C and D iliac lesions.

      Patients will be selected based on the investigator's assessment, evaluation of the
      underlying disease and the eligibility criteria. The patient's medical condition should be
      stable, with no underlying medical condition which would prevent them from performing the
      required testing or from completing the study. Patients should also be geographically stable,
      willing and able to cooperate in this clinical study and remain available for long-term
      follow-up. A patient is considered enrolled in the study after obtaining the patients
      informed consent, if there is full compliance with the study eligibility criteria and after
      successful guidewire passage through the study target lesion.

      Prior to the index procedure the following tests and clinical data will be collected:
      informed consent for data collection, demographics, medical history, medication record,
      physical examination, clinical category of chronic limb ischemia (Rutherford category) and
      resting ankle-brachial index (ABI).

      During the procedure, the vascular access can be achieved to the investigator's standard
      clinical practice. After successful lesion passage, diagnostic angiography of the lesion area
      and distal run-off is performed and angiographic measurements (vessel diameter, percentage
      stenosis and lesion length) are collected. At the physician's discretion, the patient
      receives at least 1 BeGraft Peripheral Plus Stent Graft System. Pre- and post-dilatation are
      according to the physician's discretion. No other adjunctive therapies (atherectomy, laser)
      are allowed. The complete iliac vasculature should be treated in one single session, staged
      interventions are not allowed. All outflow-limiting lesions must be treated according to the
      hospital treatment standard.

      The regular follow-ups are necessary to monitor the condition of the patient and the
      stent/procedure. Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36 months
      after the index procedure. The following data will be collected during these follow-up visit:
      medication record, physical examination, rutherford categorization, ABI and color flow
      doppler ultrasound.
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: Freedom from >50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no target lesion revascularization within 12 months.
measure: Periprocedural Serious Adverse Events (SAEs)
time frame: 30-days post-procedure
description: Periprocedural SAEs up to 30-days post-procedure, as defined according to the International Organization of Standardization (ISO) guidelines: ISO 14155:2011
measure: Primary patency rate
time frame: 1-, 6-, 24- and 36-months post-procedure
description: Freedom from >50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no target lesion revascularization within 12 months.
measure: Stent graft occlusion rate
time frame: Pre-discharge, 1-, 6- 12-, 24-, and 36-month follow-up
description: Occlusion of the stent graft system
measure: Ankle-brachial index (ABI)
time frame: 1-, 6-, 12-, 24-, and 36-month follow-up
description: ABI at follow-up compared with the baseline ABI
measure: Amputation rate
time frame: 1-, 6-, 12-, 24-, and 36-month follow-up
description: Any amputation above the knee
measure: Performance success rate
time frame: Baseline
description: Successful in sealing acute perforation or rupture, in treating aneurysms and fistulae of restoration of blood flow
measure: Freedom from target lesion revascularization (TLR)
time frame: 1-, 6-, 12-, 24-, and 36-month follow-up
description: Freedom from a repeated intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge
measure: Technical success
time frame: Index procedure
description: Ability to achieve final residual angiographic stenosis no greater than 30%
measure: Clinical success
time frame: 1-, 6-, 12-, 24-, and 36-month follow-up
description: Improvement of Rutherford classification compared to the pre-procedure Rutherford classification
arm group label: BeGraft Peripheral + Stent Graft System
arm group type: Experimental
description: Patients treated with the BeGraft Peripheral Plus Stent Graft System
intervention type: Device
intervention name: BeGraft Peripheral Plus Stent Graft System
description: Patients will be treated with the BeGraft Peripheral Plus Stent Graft System
arm group label: BeGraft Peripheral + Stent Graft System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Koen Deloose, MD
role: Study Director
affiliation: ID3 Medical
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: France
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases