<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/NCT03775226</url>
  </required_header>
  <id_info>
    <org_study_id>SFA-Israel-001</org_study_id>
    <nct_id>NCT03775226</nct_id>
  </id_info>
  <brief_title>ChampioNIR® SFA Stent EFS Study</brief_title>
  <official_title>An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the Treatment of Patients With Femoro-Popliteal Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medinol Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medinol Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the&#xD;
      Treatment of Patients with Femoro-Popliteal Disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Device Overview:&#xD;
&#xD;
      The ChampioNIR® SFA Stent is composed of a Nitinol alloy structure with an elastomeric&#xD;
      micro-fiber mesh and is designed specifically to be used in the peripheral vasculature. The&#xD;
      stent is characterized by high flexibility, strong radial support and high resistance to&#xD;
      fractures, as well as high deliverability and precise positioning.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        -  To assess the safety and feasibility of delivery and implantation of ChampioNIR® SFA&#xD;
           Stent.&#xD;
&#xD;
        -  To assess the early and long term ability of the stent to maintain vessel patency.&#xD;
&#xD;
        -  To assess the long term safety of the ChampioNIR® SFA Stent.&#xD;
&#xD;
      This study is designed as an early feasibility, prospective, open label, single arm study. 30&#xD;
      patients with infra-inguinal peripheral arterial disease appropriate for treatment with a&#xD;
      femoro-popliteal stent will be treated with ChampioNIR® SFA stent implantation. All enrolled&#xD;
      patients will be followed up at 30 days and up to 36 months. The follow-up visits will&#xD;
      include patency evaluation by duplex ultrasound.&#xD;
&#xD;
      Primary efficacy endpoint: Primary patency of the target lesion at 6 months. Primary patency&#xD;
      is defined as the absence of target lesion restenosis (defined by Duplex ultrasound (US) peak&#xD;
      systolic velocity ratio (PSVR) &gt;2.4) Primary safety endpoint: Composite rate of freedom from&#xD;
      all-cause death, target vessel revascularization or any amputation of the index limb through&#xD;
      30 days following stent implantation.&#xD;
&#xD;
      Secondary efficacy endpoints:&#xD;
&#xD;
        1. Primary patency defined by Duplex US peak systolic velocity ratio (absence of restenosis&#xD;
           which defined by Duplex US PSVR &gt;2.4) at 30 days and 12 months.&#xD;
&#xD;
        2. Acute device success, defined as achievement of a final residual diameter stenosis of&#xD;
           &lt;50% by Quantitative Angiography (QA), using the assigned treatment only.&#xD;
&#xD;
        3. Acute procedural success, defined as device success with &lt;50% residual stenosis&#xD;
           immediately after stent placement or mean trans-stenotic pressure gradient &lt;5 mmHg, and&#xD;
           without the occurrence of death, amputation or repeat revascularization of the target&#xD;
           lesion during the hospital stay.&#xD;
&#xD;
        4. Acute technical success, defined as the attainment of &lt;50% residual stenosis by QA by&#xD;
           any percutaneous method as determined by the angiographic core laboratory.&#xD;
&#xD;
        5. The following endpoints at 30 days 6, 12, 24 and 36 months:&#xD;
&#xD;
             -  Secondary Patency (absence of restenosis which is defined as Duplex US PSVR ≥ 2.4)&#xD;
&#xD;
             -  Change of Rutherford classification from baseline&#xD;
&#xD;
             -  Change of resting ankle-brachial index (ABI) from baseline&#xD;
&#xD;
             -  Change in walking impairment questionnaire from baseline&#xD;
&#xD;
             -  Change in six minute walk test from baseline&#xD;
&#xD;
      Secondary safety endpoints:&#xD;
&#xD;
        1. Combined rate of death at 30 days, target lesion revascularization (TVR), index limb&#xD;
           amputation and increase in Rutherford-Becker Classification by ≥2 classes (as compared&#xD;
           to post-procedural assessment) throughout 12 months.&#xD;
&#xD;
        2. Stent fracture at 30 days 6, 12, 24 and 36 months. Stent fractures will be analyzed by a&#xD;
           two-view X-ray evaluation by a designated core laboratory, compared with a baseline&#xD;
           two-view X-ray taken before discharge and defined as type I, II, III, IV or V as&#xD;
           follows:&#xD;
&#xD;
             -  Type I - a single strut fracture only.&#xD;
&#xD;
             -  Type II - multiple single nitinol stent fractures that can occur at different&#xD;
                sites.&#xD;
&#xD;
             -  Type III - multiple nitinol stent fractures resulting in complete transverse linear&#xD;
                fracture but without stent displacement.&#xD;
&#xD;
             -  Type IV - a complete transverse linear type III fracture with stent displacement.&#xD;
&#xD;
             -  Type V - a spiral dissection of a stent.&#xD;
&#xD;
        3. Freedom at 30 days from all-cause death, index limb amputation above the ankle and TVR.&#xD;
&#xD;
        4. The following endpoints will be assessed at 30 days, 6, 12, 24 and 36 months:&#xD;
&#xD;
             1. All-cause death&#xD;
&#xD;
             2. Amputation (above the ankle)-Free Survival (AFS)&#xD;
&#xD;
             3. Target Vessel Revascularization (TVR)&#xD;
&#xD;
             4. Re-intervention for treatment of thrombosis of the target vessel or embolization to&#xD;
                its distal vasculature&#xD;
&#xD;
        5. Major Adverse Limb Events (MALE) at 30 days, 6, 12, 24 and 36 months:&#xD;
&#xD;
             1. Stent thrombosis&#xD;
&#xD;
             2. Clinically apparent distal embolization (defined as causing end-organ damage, e.g.&#xD;
                lower extremity ulceration, tissue necrosis, or gangrene)&#xD;
&#xD;
             3. Procedure-related arterial rupture&#xD;
&#xD;
             4. Acute limb ischemia&#xD;
&#xD;
             5. Target limb amputation&#xD;
&#xD;
             6. Procedure related bleeding event requiring transfusion&#xD;
&#xD;
      Sample Size and Statistical Analysis:&#xD;
&#xD;
      The study is an early feasibility study and is not powered towards finding significant&#xD;
      differences in the primary endpoints. The sample size of up to 30 patients will allow for the&#xD;
      evaluation of feasibility and safety of the procedure, to support the initiation of a pivotal&#xD;
      study. No formal statistical power calculations were conducted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 27, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2023</completion_date>
  <primary_completion_date type="Actual">August 26, 2021</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 of the target lesion at 6 months.</measure>
    <time_frame>6 months</time_frame>
    <description>Primary patency is defined as the absence of target lesion restenosis (defined by Duplex ultrasound (US) peak systolic velocity ratio (PSVR) &gt;2.4)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite rate of freedom</measure>
    <time_frame>30 Day</time_frame>
    <description>from all-cause death, target vessel revascularization or any amputation of the index limb through 30 days following stent implantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary patency defined by Duplex US</measure>
    <time_frame>30 days and 12 months.</time_frame>
    <description>Primary patency defined by Duplex US peak systolic velocity ratio (absence of restenosis which defined by Duplex US PSVR &gt;2.4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute device success</measure>
    <time_frame>index procedure</time_frame>
    <description>defined as achievement of a final residual diameter stenosis of &lt;50% by Quantitative Angiography (QA), using the assigned treatment only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute procedural success</measure>
    <time_frame>index procedure</time_frame>
    <description>defined as device success with &lt;50% residual stenosis immediately after stent placement or mean trans-stenotic pressure gradient &lt;5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute technical success</measure>
    <time_frame>index procedure</time_frame>
    <description>defined as the attainment of &lt;50% residual stenosis by QA by any percutaneous method as determined by the angiographic core laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Patency absence of restenosis which is defined as Duplex US</measure>
    <time_frame>30 days 6, 12, 24 and 36 months</time_frame>
    <description>Secondary Patency (absence of restenosis which is defined as Duplex US PSVR ≥ 2.4)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Combined rate 30 day</measure>
    <time_frame>12 months</time_frame>
    <description>of death at 30 days, target lesion revascularization (TVR), index limb amputation and increase in Rutherford-Becker Classification by ≥2 classes (as compared to post-procedural assessment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent fractures will be analyzed by a two-view X-ray evaluation by a designated core laboratory, compared with a baseline two-view X-ray taken before discharge and defined as type I, II, III, IV or V as follow</measure>
    <time_frame>30 days 6, 12, 24 and 36 months</time_frame>
    <description>Type I - a single strut fracture only.&#xD;
Type II - multiple single nitinol stent fractures that can occur at different sites.&#xD;
Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement.&#xD;
Type IV - a complete transverse linear type III fracture with stent displacement.&#xD;
Type V - a spiral dissection of a stent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from all-cause death, index limb amputation above the ankle and TVR.</measure>
    <time_frame>30 days</time_frame>
    <description>Clinical: The number of patients who die from all causes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death</measure>
    <time_frame>30 days, 6, 12, 24 and 36 months</time_frame>
    <description>Clinical: The number of patients who die from all causes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The following Major Adverse Limb Events will be evaluated either by angiography or clinical examination. These will be assessed by reviewing angiograms by the core-lab and clinical events will be adjudicated by a CEC</measure>
    <time_frame>30 days, 6, 12, 24 and 36 months</time_frame>
    <description>Stent thrombosis&#xD;
Clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene)&#xD;
Procedure-related arterial rupture&#xD;
Acute limb ischemia&#xD;
Target limb amputation&#xD;
Procedure related bleeding event requiring transfusion&#xD;
These are clinical events, the unit of measure for all is - number of patients with any event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutherford classification</measure>
    <time_frame>30 days 6, 12, 24 and 36 months</time_frame>
    <description>Change of Rutherford classification from baseline&#xD;
It is defined as follows, with increasing severity:&#xD;
- Mild Claudication - short duration&#xD;
- Moderate Claudication - moderate exercise&#xD;
- Severe Claudication - minor exertion&#xD;
- Rest Pain&#xD;
- Minor Tissue Loss&#xD;
- Major Tissue Loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>resting ankle-brachial index</measure>
    <time_frame>30 days 6, 12, 24 and 36 months</time_frame>
    <description>Change of resting ankle-brachial index (ABI) from baseline&#xD;
Ankle Brachial Index (ABI) is a standard measure defined as:&#xD;
The systolic blood pressure at the ankle divided by the systolic blood pressure at the upper arm (brachial artery) A ratio below 0.9 is considered significant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>walking impairment questionnaire</measure>
    <time_frame>30 days 6, 12, 24 and 36 months</time_frame>
    <description>Change in walking impairment questionnaire from baseline The questionnaire will be used to assess walking capability in patients with Peripheral Arterial Disease (to evaluate the walking impairment and the efficacy of an intervention to improve walking ability in patients with Peripheral Arterial Disease, PAD).\ The patients will be required to address their walking difficulties and grade them on an increased severity scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>six minute walk test</measure>
    <time_frame>30 days 6, 12, 24 and 36 months</time_frame>
    <description>Change in six minute walk test from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amputation (above the ankle)</measure>
    <time_frame>30 days, 6, 12, 24 and 36 months</time_frame>
    <description>Amputation (above the ankle)-Free Survival (AFS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Vessel Revascularization</measure>
    <time_frame>30 days, 6, 12, 24 and 36 months</time_frame>
    <description>Target Vessel Revascularization (TVR) Will be measured by the number of patients with the event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature</measure>
    <time_frame>30 days, 6, 12, 24 and 36 months</time_frame>
    <description>Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature Will be measured by the number of patients with the event</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Single are</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This study is designed as an early feasibility, prospective, open label, single arm study. 30 patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be treated with ChampioNIR® SFA stent implantation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ChampioNIR® SFA Stent</intervention_name>
    <description>The ChampioNIR® SFA Stent is composed of a Nitinol alloy structure with an elastomeric micro-fiber mesh and is designed specifically to be used in the peripheral vasculature. The stent is characterized by high flexibility, strong radial support and high resistance to fractures, as well as high deliverability and precise positioning.</description>
    <arm_group_label>Single are</arm_group_label>
    <other_name>ChampioNIR®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years and of age of legal consent.&#xD;
&#xD;
          2. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4)&#xD;
             with a resting ankle-brachial index/toe-brachial index (ABI/TBI) &lt;0.90/0.80.&#xD;
&#xD;
          3. A single superficial femoral artery lesion with &gt;50% stenosis or total occlusion.&#xD;
&#xD;
          4. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple&#xD;
             serial lesions) ≥ 40 mm to ≤ 140 mm.&#xD;
&#xD;
          5. Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 6.0 mm by visual assessment.&#xD;
&#xD;
          6. Target lesion located with the distal point at least 3 cm above the knee joint,&#xD;
             defined as the distal end of the femur at the knee joint, and proximal point at least&#xD;
             2 cm below the origin of the profunda femoris (deep femoral artery).&#xD;
&#xD;
          7. Patent infra-popliteal and popliteal artery, i.e., single vessel runoff or better with&#xD;
             at least one of three vessels patent (&lt;50% stenosis) to the ankle or foot.&#xD;
&#xD;
          8. The target lesion(s) can be successfully crossed with a guide wire and dilated.&#xD;
&#xD;
          9. The subject is eligible for standard surgical repair, if necessary.&#xD;
&#xD;
         10. Subjects are willing to comply with scheduled visits and tests and are able and&#xD;
             willing to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Thrombophlebitis or deep venous thrombus, within the previous 30 days.&#xD;
&#xD;
          2. Presence of thrombus in the treated vessel as visualized by angiography, prior to&#xD;
             crossing the lesion.&#xD;
&#xD;
          3. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where&#xD;
             complete resolution of the thrombus was not achieved.&#xD;
&#xD;
          4. Poor aortoiliac or common femoral &quot;inflow&quot; (i.e. angiographically defined &gt;50%&#xD;
             stenosis of the iliac or common femoral artery) that would be deemed inadequate to&#xD;
             support a femoro-popliteal bypass graft and was not successfully treated prior to&#xD;
             treatment of the target lesion.&#xD;
&#xD;
          5. Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.&#xD;
&#xD;
          6. Presence of an ipsilateral arterial artificial graft.&#xD;
&#xD;
          7. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.&#xD;
&#xD;
          8. Lesions in contralateral SFA/PPA that require intervention during the index procedure,&#xD;
             or within 30 days before or after the index procedure;&#xD;
&#xD;
          9. Required stent placement (in the target or any other lesion) via a retrograde&#xD;
             approach.&#xD;
&#xD;
         10. Required stent placement (in the target or any other lesion) across or within 0.5 cm&#xD;
             of the SFA / PFA bifurcation.&#xD;
&#xD;
         11. Procedures which are pre-determined to require stent-in-stent placement to obtain&#xD;
             patency, such as in-stent restenosis.&#xD;
&#xD;
         12. Significant vessel tortuosity or other parameters prohibiting access to the lesion or&#xD;
             90° tortuosity which would prevent delivery of the stent device.&#xD;
&#xD;
         13. Required stent placement within 1 cm of a previously (in a former procedure) deployed&#xD;
             stent.&#xD;
&#xD;
         14. Use of atherectomy or other atheroablative (e.g. cryoplasty) devices at the time of&#xD;
             index procedure.&#xD;
&#xD;
         15. Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty&#xD;
             within 3 months of the index procedure.&#xD;
&#xD;
         16. Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.&#xD;
&#xD;
         17. Coronary intervention within 7 days prior to or planned within 30 days after the&#xD;
             treatment of the target lesion.&#xD;
&#xD;
         18. Stroke within the previous 90 days.&#xD;
&#xD;
         19. Known allergies to any of the following: aspirin, P2Y12 inhibitors (clopidogrel&#xD;
             bisulfate, prasugrel, OR ticagrelor), heparin OR bivalirudin, nitinol (nickel&#xD;
             titanium), or contrast agent, that cannot be medically managed.&#xD;
&#xD;
         20. Receiving dialysis or immunosuppressant therapy within the previous 30 days.&#xD;
&#xD;
         21. Known or suspected active infection at the time of the procedure.&#xD;
&#xD;
         22. History of neutropenia, coagulopathy, or thrombocytopenia.&#xD;
&#xD;
         23. Known bleeding or hypercoagulability disorder or significant anemia (Hb&lt;8.0) that&#xD;
             cannot be corrected.&#xD;
&#xD;
         24. Platelet count &lt;80,000/μL&#xD;
&#xD;
         25. International normalized ratio (INR) &gt; 1.5&#xD;
&#xD;
         26. GFR &lt;30 ml/min by Cockroft-Gault.&#xD;
&#xD;
         27. Subject requires general anesthesia for the procedure.&#xD;
&#xD;
         28. Subject has a co-morbid illness that may result in a life expectancy of less than 1&#xD;
             year&#xD;
&#xD;
         29. Planned use of a drug coated balloon (DCB) during the index procedure.&#xD;
&#xD;
         30. Pregnant women or women of child bearing potential who do not have a negative serum or&#xD;
             urine pregnancy test documented within 7 days prior to enrollment;&#xD;
&#xD;
         31. Subject is participating in any investigational study that has not yet reached its&#xD;
             primary endpoint.&#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>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah tikva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</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>
  <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/NCT03775226
org study id: SFA-Israel-001
nct id: NCT03775226
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the
      Treatment of Patients with Femoro-Popliteal Disease
Device Overview:

      The ChampioNIR® SFA Stent is composed of a Nitinol alloy structure with an elastomeric
      micro-fiber mesh and is designed specifically to be used in the peripheral vasculature. The
      stent is characterized by high flexibility, strong radial support and high resistance to
      fractures, as well as high deliverability and precise positioning.

      Objectives:

        -  To assess the safety and feasibility of delivery and implantation of ChampioNIR® SFA
           Stent.

        -  To assess the early and long term ability of the stent to maintain vessel patency.

        -  To assess the long term safety of the ChampioNIR® SFA Stent.

      This study is designed as an early feasibility, prospective, open label, single arm study. 30
      patients with infra-inguinal peripheral arterial disease appropriate for treatment with a
      femoro-popliteal stent will be treated with ChampioNIR® SFA stent implantation. All enrolled
      patients will be followed up at 30 days and up to 36 months. The follow-up visits will
      include patency evaluation by duplex ultrasound.

      Primary efficacy endpoint: Primary patency of the target lesion at 6 months. Primary patency
      is defined as the absence of target lesion restenosis (defined by Duplex ultrasound (US) peak
      systolic velocity ratio (PSVR) >2.4) Primary safety endpoint: Composite rate of freedom from
      all-cause death, target vessel revascularization or any amputation of the index limb through
      30 days following stent implantation.

      Secondary efficacy endpoints:

        1. Primary patency defined by Duplex US peak systolic velocity ratio (absence of restenosis
           which defined by Duplex US PSVR >2.4) at 30 days and 12 months.

        2. Acute device success, defined as achievement of a final residual diameter stenosis of
           <50% by Quantitative Angiography (QA), using the assigned treatment only.

        3. Acute procedural success, defined as device success with <50% residual stenosis
           immediately after stent placement or mean trans-stenotic pressure gradient <5 mmHg, and
           without the occurrence of death, amputation or repeat revascularization of the target
           lesion during the hospital stay.

        4. Acute technical success, defined as the attainment of <50% residual stenosis by QA by
           any percutaneous method as determined by the angiographic core laboratory.

        5. The following endpoints at 30 days 6, 12, 24 and 36 months:

             -  Secondary Patency (absence of restenosis which is defined as Duplex US PSVR ≥ 2.4)

             -  Change of Rutherford classification from baseline

             -  Change of resting ankle-brachial index (ABI) from baseline

             -  Change in walking impairment questionnaire from baseline

             -  Change in six minute walk test from baseline

      Secondary safety endpoints:

        1. Combined rate of death at 30 days, target lesion revascularization (TVR), index limb
           amputation and increase in Rutherford-Becker Classification by ≥2 classes (as compared
           to post-procedural assessment) throughout 12 months.

        2. Stent fracture at 30 days 6, 12, 24 and 36 months. Stent fractures will be analyzed by a
           two-view X-ray evaluation by a designated core laboratory, compared with a baseline
           two-view X-ray taken before discharge and defined as type I, II, III, IV or V as
           follows:

             -  Type I - a single strut fracture only.

             -  Type II - multiple single nitinol stent fractures that can occur at different
                sites.

             -  Type III - multiple nitinol stent fractures resulting in complete transverse linear
                fracture but without stent displacement.

             -  Type IV - a complete transverse linear type III fracture with stent displacement.

             -  Type V - a spiral dissection of a stent.

        3. Freedom at 30 days from all-cause death, index limb amputation above the ankle and TVR.

        4. The following endpoints will be assessed at 30 days, 6, 12, 24 and 36 months:

             1. All-cause death

             2. Amputation (above the ankle)-Free Survival (AFS)

             3. Target Vessel Revascularization (TVR)

             4. Re-intervention for treatment of thrombosis of the target vessel or embolization to
                its distal vasculature

        5. Major Adverse Limb Events (MALE) at 30 days, 6, 12, 24 and 36 months:

             1. Stent thrombosis

             2. Clinically apparent distal embolization (defined as causing end-organ damage, e.g.
                lower extremity ulceration, tissue necrosis, or gangrene)

             3. Procedure-related arterial rupture

             4. Acute limb ischemia

             5. Target limb amputation

             6. Procedure related bleeding event requiring transfusion

      Sample Size and Statistical Analysis:

      The study is an early feasibility study and is not powered towards finding significant
      differences in the primary endpoints. The sample size of up to 30 patients will allow for the
      evaluation of feasibility and safety of the procedure, to support the initiation of a pivotal
      study. No formal statistical power calculations were conducted.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary patency of the target lesion at 6 months.
time frame: 6 months
description: Primary patency is defined as the absence of target lesion restenosis (defined by Duplex ultrasound (US) peak systolic velocity ratio (PSVR) >2.4)
measure: Composite rate of freedom
time frame: 30 Day
description: from all-cause death, target vessel revascularization or any amputation of the index limb through 30 days following stent implantation.
measure: Primary patency defined by Duplex US
time frame: 30 days and 12 months.
description: Primary patency defined by Duplex US peak systolic velocity ratio (absence of restenosis which defined by Duplex US PSVR >2.4
measure: Acute device success
time frame: index procedure
description: defined as achievement of a final residual diameter stenosis of <50% by Quantitative Angiography (QA), using the assigned treatment only.
measure: Acute procedural success
time frame: index procedure
description: defined as device success with <50% residual stenosis immediately after stent placement or mean trans-stenotic pressure gradient <5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay.
measure: Acute technical success
time frame: index procedure
description: defined as the attainment of <50% residual stenosis by QA by any percutaneous method as determined by the angiographic core laboratory.
measure: Secondary Patency absence of restenosis which is defined as Duplex US
time frame: 30 days 6, 12, 24 and 36 months
description: Secondary Patency (absence of restenosis which is defined as Duplex US PSVR ≥ 2.4)
measure: Combined rate 30 day
time frame: 12 months
description: of death at 30 days, target lesion revascularization (TVR), index limb amputation and increase in Rutherford-Becker Classification by ≥2 classes (as compared to post-procedural assessment)
measure: Stent fractures will be analyzed by a two-view X-ray evaluation by a designated core laboratory, compared with a baseline two-view X-ray taken before discharge and defined as type I, II, III, IV or V as follow
time frame: 30 days 6, 12, 24 and 36 months
description: Type I - a single strut fracture only.
Type II - multiple single nitinol stent fractures that can occur at different sites.
Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement.
Type IV - a complete transverse linear type III fracture with stent displacement.
Type V - a spiral dissection of a stent.
measure: Freedom from all-cause death, index limb amputation above the ankle and TVR.
time frame: 30 days
description: Clinical: The number of patients who die from all causes
measure: All-cause death
time frame: 30 days, 6, 12, 24 and 36 months
description: Clinical: The number of patients who die from all causes
measure: The following Major Adverse Limb Events will be evaluated either by angiography or clinical examination. These will be assessed by reviewing angiograms by the core-lab and clinical events will be adjudicated by a CEC
time frame: 30 days, 6, 12, 24 and 36 months
description: Stent thrombosis
Clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene)
Procedure-related arterial rupture
Acute limb ischemia
Target limb amputation
Procedure related bleeding event requiring transfusion
These are clinical events, the unit of measure for all is - number of patients with any event
measure: Rutherford classification
time frame: 30 days 6, 12, 24 and 36 months
description: Change of Rutherford classification from baseline
It is defined as follows, with increasing severity:
- Mild Claudication - short duration
- Moderate Claudication - moderate exercise
- Severe Claudication - minor exertion
- Rest Pain
- Minor Tissue Loss
- Major Tissue Loss
measure: resting ankle-brachial index
time frame: 30 days 6, 12, 24 and 36 months
description: Change of resting ankle-brachial index (ABI) from baseline
Ankle Brachial Index (ABI) is a standard measure defined as:
The systolic blood pressure at the ankle divided by the systolic blood pressure at the upper arm (brachial artery) A ratio below 0.9 is considered significant
measure: walking impairment questionnaire
time frame: 30 days 6, 12, 24 and 36 months
description: Change in walking impairment questionnaire from baseline The questionnaire will be used to assess walking capability in patients with Peripheral Arterial Disease (to evaluate the walking impairment and the efficacy of an intervention to improve walking ability in patients with Peripheral Arterial Disease, PAD).\ The patients will be required to address their walking difficulties and grade them on an increased severity scale.
measure: six minute walk test
time frame: 30 days 6, 12, 24 and 36 months
description: Change in six minute walk test from baseline
measure: Amputation (above the ankle)
time frame: 30 days, 6, 12, 24 and 36 months
description: Amputation (above the ankle)-Free Survival (AFS)
measure: Target Vessel Revascularization
time frame: 30 days, 6, 12, 24 and 36 months
description: Target Vessel Revascularization (TVR) Will be measured by the number of patients with the event
measure: Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature
time frame: 30 days, 6, 12, 24 and 36 months
description: Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature Will be measured by the number of patients with the event
arm group label: Single are
arm group type: Experimental
description: This study is designed as an early feasibility, prospective, open label, single arm study. 30 patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be treated with ChampioNIR® SFA stent implantation.
intervention type: Device
intervention name: ChampioNIR® SFA Stent
description: The ChampioNIR® SFA Stent is composed of a Nitinol alloy structure with an elastomeric micro-fiber mesh and is designed specifically to be used in the peripheral vasculature. The stent is characterized by high flexibility, strong radial support and high resistance to fractures, as well as high deliverability and precise positioning.
arm group label: Single are
other name: ChampioNIR®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
sharing ipd: Undecided