<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/NCT03020290</url>
  </required_header>
  <id_info>
    <org_study_id>RC15_0464</org_study_id>
    <nct_id>NCT03020290</nct_id>
  </id_info>
  <brief_title>Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents</brief_title>
  <acronym>STELLASUPERA</acronym>
  <official_title>Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal&#xD;
      lesions. This technique tends to extend to lesions for which the gold standard remains until&#xD;
      now the open surgery treatment (lesions TASC C and D).&#xD;
&#xD;
      The primary objective of the study was to evaluate the clinical efficacy at 12 months of the&#xD;
      SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D&#xD;
      in patients with symptomatic peripheral arterial disease. The secondary objectives are to&#xD;
      evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical,&#xD;
      morphological and haemodynamic criteria, the possible influence of calcifications and the&#xD;
      quality of life of patients.&#xD;
&#xD;
      The SuperA stent treatment is not specifically provided for by the Protocol but is carried&#xD;
      out within the framework of the care. This study is an observationnal study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient will be recruiting during 1 year. Patient will be followed in the study during 2&#xD;
      years. Pre-operative exams are collected. Patients are asked to give their oral authorization&#xD;
      to participate in the study by their surgeon.&#xD;
&#xD;
      Patient can be included up to the next day of the intervention.&#xD;
&#xD;
      Endovascular treatment of femoropopliteal lesion with SuperA stents during medical care:&#xD;
&#xD;
      Intervention will be achieved in operative room, under local anesthesia and sedation or&#xD;
      general anesthesia. An angio-CT or an arteriography is necessary to attest the presence for&#xD;
      TASC C or D lesion involving the superficial femoral and/or popliteal arteries.&#xD;
&#xD;
      The long femoropopliteal lesion must be pre-dilated during 3 minutes with a balloon of 1mm&#xD;
      diameter more than the stent to be implanted.&#xD;
&#xD;
      A control arteriography will be done before the implantation of the stent and at the end of&#xD;
      the intervention to assess the success of the procedure.&#xD;
&#xD;
      If needed, endovascular treatment could be realized on the inflow or outflow in the same&#xD;
      time.&#xD;
&#xD;
      Patient follow-up :&#xD;
&#xD;
      Patient follow-up is performed at 1, 6, 12 and 24 months. Follow-up will systematically&#xD;
      include a clinical evaluation and a duplex scan with the ankle brachial index (ABI).&#xD;
&#xD;
      The x-rays and the quality of life questionnaire will be done at 1, 12 and 24 months.&#xD;
&#xD;
      All clinical surveillance events, complications and re-hospitalizations will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">April 10, 2018</completion_date>
  <primary_completion_date type="Actual">April 10, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patient with improvement of at least one category of Rutherford classification</measure>
    <time_frame>12 months</time_frame>
    <description>To evaluate the sustained clinical effectiveness of the SuperA stent (Abbott) at 12-month for TASC C and D atherosclerotic femoropopliteal lesions in patients with symptomatic primary artery disease (PAD) (RUTHERFORD 2 to 6).&#xD;
Improvement of at least 1 category of Rutherford classification for claudicants.&#xD;
Healing of a trophic disorder and disappearance of resting pain for patient with critical ischemia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patient with improvement of at least one category of Rutherford classification</measure>
    <time_frame>24 months</time_frame>
    <description>clinical effectiveness of the SuperA stent measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patient presenting a major adverse cardiovascular event</measure>
    <time_frame>24 months</time_frame>
    <description>clinical effectiveness of the SuperA stent measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patient presenting a major adverse limb event</measure>
    <time_frame>24 months</time_frame>
    <description>clinical effectiveness of the SuperA stent measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>limb salvage rate measurement</measure>
    <time_frame>24 months</time_frame>
    <description>clinical effectiveness of the SuperA stent measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of Target Lesion Revascularization (TLR)</measure>
    <time_frame>24 months</time_frame>
    <description>Effectiveness of the SuperA stent measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of Target Extremity Revascularization (TER)</measure>
    <time_frame>24 months</time_frame>
    <description>Effectiveness of the SuperA stent measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patient with sustained permeability without restenosis &gt; 30% in lack of reintervention</measure>
    <time_frame>24 months</time_frame>
    <description>hemodynamic effectiveness of the SuperA stent measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patient with sustained permeability without restenosis &gt; 30% after reintervention</measure>
    <time_frame>24 months</time_frame>
    <description>hemodynamic effectiveness of the SuperA stent measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>variation of the ABI (Ankle systolic pression (mmHg) / brachial systolique pression (mmHg) index) before and after surgery</measure>
    <time_frame>24 months</time_frame>
    <description>hemodynamic effectiveness of the SuperA stent measurement&#xD;
(restenosis, thrombosis) and morphologic criteria (stenting length, stent fracture).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>restenosis measurement</measure>
    <time_frame>24 months</time_frame>
    <description>hemodynamic effectiveness of the SuperA stent measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>thrombosis measurement</measure>
    <time_frame>24 months</time_frame>
    <description>hemodynamic effectiveness of the SuperA stent measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stenting length measurement</measure>
    <time_frame>24 months</time_frame>
    <description>morphologic criteria of effectiveness of the SuperA stent measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stent fracture measurement</measure>
    <time_frame>24 months</time_frame>
    <description>morphologic criteria of effectiveness of the SuperA stent measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life in patients treated with the SuperA stent</measure>
    <time_frame>1 month</time_frame>
    <description>EuroQol five dimensions questionnaire (EQ5D-3L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life in patients treated with the SuperA stent</measure>
    <time_frame>12 months</time_frame>
    <description>EQ5D-3L questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life in patients treated with the SuperA stent</measure>
    <time_frame>24months</time_frame>
    <description>EQ5D-3L questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of vessel calcification rate</measure>
    <time_frame>24months</time_frame>
    <description>For predictive factors of failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of elongation rate of SuperA</measure>
    <time_frame>24months</time_frame>
    <description>For predictive factors of failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of stent diameter</measure>
    <time_frame>24months</time_frame>
    <description>For predictive factors of failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient presenting cardiovascular comorbidity</measure>
    <time_frame>24months</time_frame>
    <description>For predictive factors of failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient presenting a renal dysfunction (creatinine clearance &lt; 60 mL/min and/or dialysis)</measure>
    <time_frame>24months</time_frame>
    <description>For predictive factors of failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient treated with anti-platelet therapy</measure>
    <time_frame>24months</time_frame>
    <description>For predictive factors of failure</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">335</enrollment>
  <condition>Atherosclerosis Obliterans</condition>
  <arm_group>
    <arm_group_label>patients with femoropopliteal lesion</arm_group_label>
    <description>patients with femoropopliteal lesion - Endovascular treatment for PAD during medical care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endovascular treatment for PAD during medical care (SuperA stent (Abbott))</intervention_name>
    <description>Long femoropopliteal stenting with SuperA devices during medical care. The endovascular treatment for PAD will be done during the usual medical treatment of patient. The intervention is not carried out within the framework of the research protocol</description>
    <arm_group_label>patients with femoropopliteal lesion</arm_group_label>
    <other_name>long femoropopliteal revascularization</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients included in this study are major patients and have lower limb arteriopathy&#xD;
        requiring a therapeutic gesture in the femoro-popliteal segment. The inclusion in this&#xD;
        study will be proposed to the patients during the consultation of preoperative vascular&#xD;
        surgery or during the hospitalization, until the day after their intervention. The number&#xD;
        of subjects planned is 50.&#xD;
&#xD;
        In the case where the patient has bilateral femoropopliteal lesions, the limbs being&#xD;
        treated in separate hospitalizations, both members may be treated with SuperA stents. The&#xD;
        two members will then be considered independently of each other.&#xD;
&#xD;
        Patients with associated lesions requiring treatment, any artery confused, may be treated&#xD;
        at the same operative time if deemed necessary by the surgeon.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age &gt; 18 years,&#xD;
&#xD;
          -  Symptomatic PAD, Rutherford 2 to 6&#xD;
&#xD;
          -  Atherosclerotic femoropopliteal lesion TASC C or D (on CT scan or arteriography)&#xD;
&#xD;
          -  De novo femoropopliteal lesion&#xD;
&#xD;
          -  Patient informed of the study and oral authorization collected&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under-age patient&#xD;
&#xD;
          -  Patient of age, but under legal guardianship or care&#xD;
&#xD;
          -  Potentially pregnant women&#xD;
&#xD;
          -  Patients do not understand the French language&#xD;
&#xD;
          -  Asymptomatic lesion&#xD;
&#xD;
          -  Acute ischemia or acute thrombosis&#xD;
&#xD;
          -  Lesion already treated&#xD;
&#xD;
          -  No-atherosclerotic disease&#xD;
&#xD;
          -  hemostasis disorder&#xD;
&#xD;
          -  severe comorbidity with life expectancy less than 2 years&#xD;
&#xD;
          -  contraindication of antiplatelet (dual antiplatelet therapy required during at least 2&#xD;
             month post-intervention)&#xD;
&#xD;
          -  patient participating in a clinical trial likely to interfer&#xD;
&#xD;
          -  Comorbidity or other, according investigator, that may interferer with the conduct of&#xD;
             the study&#xD;
&#xD;
          -  lesion near to an aneurysm&#xD;
&#xD;
          -  Patient follow-up impossible&#xD;
&#xD;
          -  Patient refuse to participate&#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>Yann Goueffic, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>yann.goueffic@chu-nantes.fr</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHD Vendée</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nantes CHU</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>femoropopliteal artery</keyword>
  <keyword>interwoven nitinol stent</keyword>
  <keyword>self-expanding-endovascular</keyword>
  <keyword>TASC C and TASC D</keyword>
  <keyword>Peripheral Arterial Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</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/NCT03020290
org study id: RC15_0464
nct id: NCT03020290
lead sponsor: 
collaborator: 
has dmc: No
Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal
      lesions. This technique tends to extend to lesions for which the gold standard remains until
      now the open surgery treatment (lesions TASC C and D).

      The primary objective of the study was to evaluate the clinical efficacy at 12 months of the
      SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D
      in patients with symptomatic peripheral arterial disease. The secondary objectives are to
      evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical,
      morphological and haemodynamic criteria, the possible influence of calcifications and the
      quality of life of patients.

      The SuperA stent treatment is not specifically provided for by the Protocol but is carried
      out within the framework of the care. This study is an observationnal study.
Patient will be recruiting during 1 year. Patient will be followed in the study during 2
      years. Pre-operative exams are collected. Patients are asked to give their oral authorization
      to participate in the study by their surgeon.

      Patient can be included up to the next day of the intervention.

      Endovascular treatment of femoropopliteal lesion with SuperA stents during medical care:

      Intervention will be achieved in operative room, under local anesthesia and sedation or
      general anesthesia. An angio-CT or an arteriography is necessary to attest the presence for
      TASC C or D lesion involving the superficial femoral and/or popliteal arteries.

      The long femoropopliteal lesion must be pre-dilated during 3 minutes with a balloon of 1mm
      diameter more than the stent to be implanted.

      A control arteriography will be done before the implantation of the stent and at the end of
      the intervention to assess the success of the procedure.

      If needed, endovascular treatment could be realized on the inflow or outflow in the same
      time.

      Patient follow-up :

      Patient follow-up is performed at 1, 6, 12 and 24 months. Follow-up will systematically
      include a clinical evaluation and a duplex scan with the ankle brachial index (ABI).

      The x-rays and the quality of life questionnaire will be done at 1, 12 and 24 months.

      All clinical surveillance events, complications and re-hospitalizations will be collected.
observational model: Case-Only
time perspective: Prospective
measure: Number of patient with improvement of at least one category of Rutherford classification
time frame: 12 months
description: To evaluate the sustained clinical effectiveness of the SuperA stent (Abbott) at 12-month for TASC C and D atherosclerotic femoropopliteal lesions in patients with symptomatic primary artery disease (PAD) (RUTHERFORD 2 to 6).
Improvement of at least 1 category of Rutherford classification for claudicants.
Healing of a trophic disorder and disappearance of resting pain for patient with critical ischemia
measure: Number of patient with improvement of at least one category of Rutherford classification
time frame: 24 months
description: clinical effectiveness of the SuperA stent measurement
measure: number of patient presenting a major adverse cardiovascular event
time frame: 24 months
description: clinical effectiveness of the SuperA stent measurement
measure: number of patient presenting a major adverse limb event
time frame: 24 months
description: clinical effectiveness of the SuperA stent measurement
measure: limb salvage rate measurement
time frame: 24 months
description: clinical effectiveness of the SuperA stent measurement
measure: rate of Target Lesion Revascularization (TLR)
time frame: 24 months
description: Effectiveness of the SuperA stent measurement
measure: rate of Target Extremity Revascularization (TER)
time frame: 24 months
description: Effectiveness of the SuperA stent measurement
measure: number of patient with sustained permeability without restenosis > 30% in lack of reintervention
time frame: 24 months
description: hemodynamic effectiveness of the SuperA stent measurement
measure: number of patient with sustained permeability without restenosis > 30% after reintervention
time frame: 24 months
description: hemodynamic effectiveness of the SuperA stent measurement
measure: variation of the ABI (Ankle systolic pression (mmHg) / brachial systolique pression (mmHg) index) before and after surgery
time frame: 24 months
description: hemodynamic effectiveness of the SuperA stent measurement
(restenosis, thrombosis) and morphologic criteria (stenting length, stent fracture).
measure: restenosis measurement
time frame: 24 months
description: hemodynamic effectiveness of the SuperA stent measurement
measure: thrombosis measurement
time frame: 24 months
description: hemodynamic effectiveness of the SuperA stent measurement
measure: stenting length measurement
time frame: 24 months
description: morphologic criteria of effectiveness of the SuperA stent measurement
measure: stent fracture measurement
time frame: 24 months
description: morphologic criteria of effectiveness of the SuperA stent measurement
measure: quality of life in patients treated with the SuperA stent
time frame: 1 month
description: EuroQol five dimensions questionnaire (EQ5D-3L)
measure: quality of life in patients treated with the SuperA stent
time frame: 12 months
description: EQ5D-3L questionnaire
measure: quality of life in patients treated with the SuperA stent
time frame: 24months
description: EQ5D-3L questionnaire
measure: Assessment of vessel calcification rate
time frame: 24months
description: For predictive factors of failure
measure: Assessment of elongation rate of SuperA
time frame: 24months
description: For predictive factors of failure
measure: Assessment of stent diameter
time frame: 24months
description: For predictive factors of failure
measure: Number of patient presenting cardiovascular comorbidity
time frame: 24months
description: For predictive factors of failure
measure: Number of patient presenting a renal dysfunction (creatinine clearance < 60 mL/min and/or dialysis)
time frame: 24months
description: For predictive factors of failure
measure: Number of patient treated with anti-platelet therapy
time frame: 24months
description: For predictive factors of failure
arm group label: patients with femoropopliteal lesion
description: patients with femoropopliteal lesion - Endovascular treatment for PAD during medical care
intervention type: Device
intervention name: Endovascular treatment for PAD during medical care (SuperA stent (Abbott))
description: Long femoropopliteal stenting with SuperA devices during medical care. The endovascular treatment for PAD will be done during the usual medical treatment of patient. The intervention is not carried out within the framework of the research protocol
arm group label: patients with femoropopliteal lesion
other name: long femoropopliteal revascularization
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yann Goueffic, PU-PH
role: Principal Investigator
affiliation: yann.goueffic@chu-nantes.fr
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Atherosclerosis