<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/NCT03037411</url>
  </required_header>
  <id_info>
    <org_study_id>S2346</org_study_id>
    <nct_id>NCT03037411</nct_id>
  </id_info>
  <brief_title>A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries</brief_title>
  <acronym>REGAL</acronym>
  <official_title>A Real World Evaluation of the ELUVIA Drug Eluting Stent in All-Comers With Superficial Femoral Artery and Proximal Popliteal Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up&#xD;
      (PMCF) trial providing additional data including health economics data to support the use of&#xD;
      the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing&#xD;
      additional data including health economics data to support the use of the ELUVIA stent in the&#xD;
      treatment of lesions located in the femoropopliteal arteries.&#xD;
&#xD;
      The objective of the study is to collect additional data including health economics data to&#xD;
      support the use of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating&#xD;
      Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2016</start_date>
  <completion_date type="Actual">March 24, 2022</completion_date>
  <primary_completion_date type="Actual">March 24, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Health care costs</measure>
    <time_frame>Index Procedure, 1, 6, 12 and 24 months</time_frame>
    <description>Health care costs at index procedure and changes in health care costs from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Improvement</measure>
    <time_frame>1, 6, 12 and 24 months</time_frame>
    <description>Change in EQ-5D-5L™ from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking Improvement</measure>
    <time_frame>1, 6, 12 and 24 months</time_frame>
    <description>Change in Walking Impairment Questionnaire (WIQ) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Primary and Secondary Sustained Clinical Improvement</measure>
    <time_frame>1, 6, 12 and 24 months</time_frame>
    <description>Changes in Rutherford Classification from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Hemodynamic Improvement</measure>
    <time_frame>1, 6, 12 and 24 months</time_frame>
    <description>Changes in in Ankle-Brachial Index (ABI) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization</measure>
    <time_frame>1, 6, 12 and 24 months</time_frame>
    <description>Changes in healthcare utilization over time</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Technical success of the stenting procedure</measure>
    <time_frame>During stenting procedure</time_frame>
    <description>Technical success defined as delivery and deployment of the study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% assessed visually</description>
  </other_outcome>
  <other_outcome>
    <measure>Procedural success of the stenting procedure</measure>
    <time_frame>within 24 hours of stenting procedure</time_frame>
    <description>Procedural success defined as technical success with no MAEs noted within 24 hours of the stenting procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Event and Major Adverse Event (MAE) rate</measure>
    <time_frame>1, 6, 12 and 24 months</time_frame>
    <description>Adverse Event rate and MAE rate, defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization rate at each time point</description>
  </other_outcome>
  <other_outcome>
    <measure>Primary patency</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>Primary patency of target lesion assessed by duplex ultrasound as adjudicated by an independent core laboratory</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinically-driven Target Lesion Revascularization (TLR) Rate</measure>
    <time_frame>1, 6, 12 and 24 months</time_frame>
    <description>Target Lesion Revascularization is defined as any surgical or percutaneous intervention to the target lesion(s) after the stenting procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinically-driven Target Vessel Revascularization (TVR) Rate</measure>
    <time_frame>1, 6, 12 and 24 months</time_frame>
    <description>Target Vessel Revascularization is defined as any surgical or percutaneous intervention to the target vessel after the stenting procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>Distribution of Rutherford Classification</measure>
    <time_frame>1, 6, 12 and 24 months</time_frame>
    <description>Rutherford Classification:&#xD;
0 Asymptomatic - Normal Treadmill /stress test&#xD;
Mild claudication - Completes treadmill exercise; ankle pressure (AP) after exercise &lt;50mm Hg, but &gt;25 mm Hg less than BP&#xD;
Moderate claudication - Between categories 1 and 3&#xD;
Severe claudication - Cannot complete treadmill exercise and AP after exercise &lt;50 mm Hg&#xD;
Ischemic rest pain - Resting AP &lt;40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); toe pressure (TP) &lt;30 mm Hg&#xD;
Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal edema - Resting AP &lt;60 mm Hg, ankle or metatarsal (MT) PVR flat or barely pulsatile; TP &lt;40 mm Hg&#xD;
Major tissue loss-extending above MT level - Same as Category 5</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">291</enrollment>
  <condition>Arterial Occlusive Diseases</condition>
  <condition>Atherosclerosis</condition>
  <condition>Vascular Diseases</condition>
  <condition>Arteriosclerosis</condition>
  <arm_group>
    <arm_group_label>ELUVIA stent implantation</arm_group_label>
    <description>Peripheral stenting</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Peripheral stenting</intervention_name>
    <description>stent implantation during the index procedure</description>
    <arm_group_label>ELUVIA stent implantation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The Intended population for the REGAL study are 'real world'-patients with symptomatic&#xD;
        de-novo, restenotic, or (re)occluded lesions in the native superficial femoral artery (SFA)&#xD;
        and/or proximal popliteal artery with reference vessel diameter (RVD) ranging from 4.0-6.0&#xD;
        mm, suitable for endovascular treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects age 18 and older&#xD;
&#xD;
          2. Subject is willing and able to provide written consent before any study-specific test&#xD;
             or procedure is performed and agrees to attend all follow-up visits&#xD;
&#xD;
          3. De novo, restenotic or (re)occluded lesions in the native femoro-popliteal arteries,&#xD;
             with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, suitable for&#xD;
             endovascular treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is pregnant or planning to become pregnant during the course of the study&#xD;
&#xD;
          2. Life expectancy of less than 1 year (which is defined as documented life expectancy&#xD;
             less than 12 months due to other medical co-morbid condition(s) that could limit the&#xD;
             subject's ability to participate in the clinical follow-up, limit the subject's&#xD;
             compliance with the standard of care follow-up, or impact the scientific integrity of&#xD;
             the trial)&#xD;
&#xD;
          3. Known allergy to the ELUVIA stent system or any of its components, concomitant&#xD;
             medication, contrast agents (that cannot be medically managed)&#xD;
&#xD;
          4. Subject enrolled in an investigational study that has not reached primary endpoint at&#xD;
             the time of enrollment or that clinically interferes with the current study&#xD;
             assessments (Note: studies requiring extended follow-up for products that were&#xD;
             investigational, but have become commercially available since then are not considered&#xD;
             investigational studies)&#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>Carlo Setacci</last_name>
    <role>Principal Investigator</role>
    <affiliation>Policlinico Le Scotte, Siena</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medizinische Universität Graz</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZOL Genk</name>
      <address>
        <city>Genk</city>
        <state>Limburg</state>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regionaal Ziekenhuis Heilig Hart Tienen</name>
      <address>
        <city>Tienen</city>
        <state>Vlaams-Brabant</state>
        <zip>3300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Sart Tilman</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Grenoble-Alpes</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Parly II</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASL Asti</name>
      <address>
        <city>Asti</city>
        <zip>14100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Vittorio Emanuele</name>
      <address>
        <city>Catania</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico di Monza</name>
      <address>
        <city>Monza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Umberto I</name>
      <address>
        <city>Roma</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L'Azienda sanitaira ASL Roma 1</name>
      <address>
        <city>Roma</city>
        <zip>00193</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Donato</name>
      <address>
        <city>San Donato Milanese</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Azienda Ospedaliera Universitaria Senese</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Burgos</name>
      <address>
        <city>Burgos</city>
        <zip>09006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Puerta del Mar</name>
      <address>
        <city>Cadiz</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Pedro de Alcántara</name>
      <address>
        <city>Cáceres</city>
        <zip>10004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp . Universitario de Guadalajara</name>
      <address>
        <city>Guadalajara</city>
        <zip>19002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Ntra Sra. del Rosario</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Complejo Hosp Universitario (CHUO)</name>
      <address>
        <city>Ourense</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Montecelo (Pontevedra EOXI)</name>
      <address>
        <city>Pontevedra</city>
        <zip>30071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Parc Tauli</name>
      <address>
        <city>Sabadell</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foundation for the Aragonese Healthcare Research Institute</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Italy</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>November 23, 2022</last_update_submitted>
  <last_update_submitted_qc>November 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atherosclerosis</keyword>
  <keyword>Superficial Femoral Artery (SFA)</keyword>
  <keyword>Proximal Popliteal Artery (PPA)</keyword>
  <keyword>Stenting</keyword>
  <keyword>Paclitaxel</keyword>
  <keyword>Health Economics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Arteriosclerosis</mesh_term>
    <mesh_term>Arterial Occlusive Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 3, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03037411
org study id: S2346
nct id: NCT03037411
lead sponsor: 
has dmc: No
The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up
      (PMCF) trial providing additional data including health economics data to support the use of
      the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.
A European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing
      additional data including health economics data to support the use of the ELUVIA stent in the
      treatment of lesions located in the femoropopliteal arteries.

      The objective of the study is to collect additional data including health economics data to
      support the use of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating
      Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
observational model: Cohort
time perspective: Prospective
measure: Health care costs
time frame: Index Procedure, 1, 6, 12 and 24 months
description: Health care costs at index procedure and changes in health care costs from baseline
measure: Quality of Life Improvement
time frame: 1, 6, 12 and 24 months
description: Change in EQ-5D-5L™ from baseline
measure: Walking Improvement
time frame: 1, 6, 12 and 24 months
description: Change in Walking Impairment Questionnaire (WIQ) from baseline
measure: Rate of Primary and Secondary Sustained Clinical Improvement
time frame: 1, 6, 12 and 24 months
description: Changes in Rutherford Classification from baseline
measure: Rate of Hemodynamic Improvement
time frame: 1, 6, 12 and 24 months
description: Changes in in Ankle-Brachial Index (ABI) from baseline
measure: Health care utilization
time frame: 1, 6, 12 and 24 months
description: Changes in healthcare utilization over time
measure: Technical success of the stenting procedure
time frame: During stenting procedure
description: Technical success defined as delivery and deployment of the study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% assessed visually
measure: Procedural success of the stenting procedure
time frame: within 24 hours of stenting procedure
description: Procedural success defined as technical success with no MAEs noted within 24 hours of the stenting procedure
measure: Adverse Event and Major Adverse Event (MAE) rate
time frame: 1, 6, 12 and 24 months
description: Adverse Event rate and MAE rate, defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization rate at each time point
measure: Primary patency
time frame: 6, 12 and 24 months
description: Primary patency of target lesion assessed by duplex ultrasound as adjudicated by an independent core laboratory
measure: Clinically-driven Target Lesion Revascularization (TLR) Rate
time frame: 1, 6, 12 and 24 months
description: Target Lesion Revascularization is defined as any surgical or percutaneous intervention to the target lesion(s) after the stenting procedure
measure: Clinically-driven Target Vessel Revascularization (TVR) Rate
time frame: 1, 6, 12 and 24 months
description: Target Vessel Revascularization is defined as any surgical or percutaneous intervention to the target vessel after the stenting procedure
measure: Distribution of Rutherford Classification
time frame: 1, 6, 12 and 24 months
description: Rutherford Classification:
0 Asymptomatic - Normal Treadmill /stress test
Mild claudication - Completes treadmill exercise; ankle pressure (AP) after exercise <50mm Hg, but >25 mm Hg less than BP
Moderate claudication - Between categories 1 and 3
Severe claudication - Cannot complete treadmill exercise and AP after exercise <50 mm Hg
Ischemic rest pain - Resting AP <40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); toe pressure (TP) <30 mm Hg
Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal edema - Resting AP <60 mm Hg, ankle or metatarsal (MT) PVR flat or barely pulsatile; TP <40 mm Hg
Major tissue loss-extending above MT level - Same as Category 5
arm group label: ELUVIA stent implantation
description: Peripheral stenting
intervention type: Device
intervention name: Peripheral stenting
description: stent implantation during the index procedure
arm group label: ELUVIA stent implantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carlo Setacci
role: Principal Investigator
affiliation: Policlinico Le Scotte, Siena
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country: Austria
country: Belgium
country: France
country: Italy
country: Spain
responsible party type: Sponsor
mesh term: Atherosclerosis
mesh term: Vascular Diseases
mesh term: Arteriosclerosis
mesh term: Arterial Occlusive Diseases
sharing ipd: Undecided
submitted: August 3, 2023