<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/NCT04496544</url>
  </required_header>
  <id_info>
    <org_study_id>2019P000950</org_study_id>
    <nct_id>NCT04496544</nct_id>
  </id_info>
  <brief_title>Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)</brief_title>
  <acronym>SAFE-PAD</acronym>
  <official_title>Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Philips Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bard Peripheral Vascular, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cook Medical</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The SAFE-PAD Study aims to evaluate the long-term safety of paclitaxel-coated devices&#xD;
      compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization&#xD;
      among a broad, real-world population of patients with peripheral artery disease. This&#xD;
      multi-year analysis aims to create an ongoing mechanism to evaluate the safety of&#xD;
      paclitaxel-coated devices in real world practice. The null hypothesis is that the&#xD;
      paclitaxel-coated devices are associated with an increase in mortality relative to the&#xD;
      non-drug-coated devices beyond an acceptable magnitude (i.e. the non-inferiority margin), and&#xD;
      the alternative hypothesis is that paclitaxel-coated devices are not associated with an&#xD;
      increase in mortality relative to the non-drug-coated devices beyond the non-inferiority&#xD;
      margin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational retrospective cohort study using claims data to evaluate the&#xD;
      long-term safety of paclitaxel-coated devices compared with non-drug coated devices for&#xD;
      femoropopliteal artery revascularization, with median follow-up time for the population&#xD;
      surpassing 5 years. A series of supplemental sensitivity analyses will be conducted to assess&#xD;
      and mitigate the potential for unmeasured confounding and to determine the impact of repeat&#xD;
      interventions and paclitaxel exposure on survival. Finally, sub-group analyses will be&#xD;
      performed to investigate whether there is differential safety of paclitaxel-coated devices&#xD;
      across different patient profiles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>Time from index procedure date to the date of death, to be updated periodically until the median duration of follow-up for the cohort reaches 5 years</time_frame>
    <description>All-cause mortality of patients who underwent femoropopliteal artery revascularization with drug-coated devices or non-drug-coated devices</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Repeat hospitalization</measure>
    <time_frame>1, 2 and 3 years after index procedure</time_frame>
    <description>Rates of repeat hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeat endovascular or surgical revascularization</measure>
    <time_frame>1, 2 and 3 years after index procedure</time_frame>
    <description>Rates of repeat endovascular or surgical revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel revascularization</measure>
    <time_frame>1, 2 and 3 years after index procedure</time_frame>
    <description>Rates of target vessel revascularization among inpatient procedures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower extremity amputation</measure>
    <time_frame>1, 2 and 3 years after index procedure</time_frame>
    <description>Rates of lower extremity amputation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimal medical therapy</measure>
    <time_frame>1, 2 and 3 years after index procedure</time_frame>
    <description>Rates of optimal medical therapy</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">250000</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Paclitaxel Adverse Reaction</condition>
  <condition>Safety Issues</condition>
  <arm_group>
    <arm_group_label>Drug-Coated Devices</arm_group_label>
    <description>Medicare fee-for-service beneficiaries who underwent femoropopliteal artery revascularization with drug-coated devices (drug-eluting stent ± drug-coated balloon, bare metal stent with drug-coated balloon, or drug-coated balloon alone)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Drug-Coated Devices</arm_group_label>
    <description>Medicare fee-for-service beneficiaries who underwent femoropopliteal artery revascularization with non-drug-coated devices (bare metal stent ± percutaneous transluminal balloon angioplasty or percutaneous transluminal balloon angioplasty alone)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Retrospective data collection</intervention_name>
    <description>No intervention; retrospective data collection</description>
    <arm_group_label>Drug-Coated Devices</arm_group_label>
    <arm_group_label>Non-Drug-Coated Devices</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study cohort will include all Medicare fee-for-service beneficiaries who underwent&#xD;
        femoropopliteal artery revascularization with either drug-coated devices (drug-eluting&#xD;
        stent [DES] ± drug-coated balloon [DCB], bare metal stent [BMS] with DCB, or DCB alone) or&#xD;
        non-drug-coated devices (BMS ± percutaneous transluminal angioplasty [PTA] or PTA alone).&#xD;
        Each group will additionally be composed of two device-specific subgroups: a DCB sub-group&#xD;
        and DES sub-group in the drug-coated group, and a PTA sub-group and a BMS sub-group in the&#xD;
        non-drug group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All fee-for-service Medicare beneficiaries who underwent femoropopliteal artery&#xD;
             revascularization. Patients are allowed to undergo simultaneous revascularization of&#xD;
             lesions outside this target vessel during the same procedure.&#xD;
&#xD;
          -  All patients with ≥1 year of Medicare claims data prior to their index procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without 1 year of Medicare claims data prior to their index revascularization&#xD;
             procedure.&#xD;
&#xD;
          -  Patients that do not have both a carrier file charge and an institutional file charge&#xD;
             on the date of an outpatient procedure. This removes procedures performed in certain&#xD;
             clinical settings, such as office-based clinics, that do not submit the Healthcare&#xD;
             Common Procedure Coding System (HCPCS) code needed to identify drug-coated devices.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>66 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric A Secemsky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert W Yeh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Eric Secemsky</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </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>No</sharing_ipd>
    <ipd_description>As restricted by the data use agreement with the Centers for Medicare and Medicaid Services (CMS), we will not allow any data sharing for this project and we will not make any distribution of the CMS data.</ipd_description>
  </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/NCT04496544
org study id: 2019P000950
nct id: NCT04496544
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The SAFE-PAD Study aims to evaluate the long-term safety of paclitaxel-coated devices
      compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization
      among a broad, real-world population of patients with peripheral artery disease. This
      multi-year analysis aims to create an ongoing mechanism to evaluate the safety of
      paclitaxel-coated devices in real world practice. The null hypothesis is that the
      paclitaxel-coated devices are associated with an increase in mortality relative to the
      non-drug-coated devices beyond an acceptable magnitude (i.e. the non-inferiority margin), and
      the alternative hypothesis is that paclitaxel-coated devices are not associated with an
      increase in mortality relative to the non-drug-coated devices beyond the non-inferiority
      margin.
This is an observational retrospective cohort study using claims data to evaluate the
      long-term safety of paclitaxel-coated devices compared with non-drug coated devices for
      femoropopliteal artery revascularization, with median follow-up time for the population
      surpassing 5 years. A series of supplemental sensitivity analyses will be conducted to assess
      and mitigate the potential for unmeasured confounding and to determine the impact of repeat
      interventions and paclitaxel exposure on survival. Finally, sub-group analyses will be
      performed to investigate whether there is differential safety of paclitaxel-coated devices
      across different patient profiles.
observational model: Cohort
time perspective: Retrospective
measure: All-cause mortality
time frame: Time from index procedure date to the date of death, to be updated periodically until the median duration of follow-up for the cohort reaches 5 years
description: All-cause mortality of patients who underwent femoropopliteal artery revascularization with drug-coated devices or non-drug-coated devices
measure: Repeat hospitalization
time frame: 1, 2 and 3 years after index procedure
description: Rates of repeat hospitalization
measure: Repeat endovascular or surgical revascularization
time frame: 1, 2 and 3 years after index procedure
description: Rates of repeat endovascular or surgical revascularization
measure: Target vessel revascularization
time frame: 1, 2 and 3 years after index procedure
description: Rates of target vessel revascularization among inpatient procedures
measure: Lower extremity amputation
time frame: 1, 2 and 3 years after index procedure
description: Rates of lower extremity amputation
measure: Optimal medical therapy
time frame: 1, 2 and 3 years after index procedure
description: Rates of optimal medical therapy
arm group label: Drug-Coated Devices
description: Medicare fee-for-service beneficiaries who underwent femoropopliteal artery revascularization with drug-coated devices (drug-eluting stent ± drug-coated balloon, bare metal stent with drug-coated balloon, or drug-coated balloon alone)
arm group label: Non-Drug-Coated Devices
description: Medicare fee-for-service beneficiaries who underwent femoropopliteal artery revascularization with non-drug-coated devices (bare metal stent ± percutaneous transluminal balloon angioplasty or percutaneous transluminal balloon angioplasty alone)
intervention type: Other
intervention name: Retrospective data collection
description: No intervention; retrospective data collection
arm group label: Drug-Coated Devices
arm group label: Non-Drug-Coated Devices
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 66 Years
maximum age: N/A
healthy volunteers: No
last name: Eric A Secemsky, MD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
last name: Robert W Yeh, MD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Eric Secemsky
investigator title: Assistant Professor of Medicine
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
sharing ipd: No
ipd description: As restricted by the data use agreement with the Centers for Medicare and Medicaid Services (CMS), we will not allow any data sharing for this project and we will not make any distribution of the CMS data.