<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/NCT03260517</url>
  </required_header>
  <id_info>
    <org_study_id>MDT17027DCB001</org_study_id>
    <nct_id>NCT03260517</nct_id>
  </id_info>
  <brief_title>The PREVAIL Study</brief_title>
  <acronym>PREVAIL</acronym>
  <official_title>A Clinical PeRformance EVAluatIon of a New Medtronic Coronary Drug-Coated BaLloon Catheter for the Treatment of De Novo Lesions, In-Stent Restenosis and Small Vessel Disease in Coronary Arteries: The PREVAIL Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Vascular</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Vascular</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>
      To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon&#xD;
      Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis&#xD;
      with coronary lesions previously treated with drug-eluting or bare metal stents in native&#xD;
      coronary arteries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, pre-market, multi-center, single arm study evaluating up to 50&#xD;
      subjects with symptoms of ischemic heart disease attributable to stenotic lesions of the&#xD;
      coronary arteries that are amenable to treatment with the Medtronic Coronary Drug-Coated&#xD;
      Balloon Catheter.&#xD;
&#xD;
      Patients with de novo lesions, In-Stent Restenosis or small vessel disease who qualify for&#xD;
      percutaneous coronary interventions treatable with the device with a diameter between 2.0 mm&#xD;
      to 4.0 mm and a length ≤25 mm will be screened and are intended to participate in this study.&#xD;
&#xD;
      Each subject is expected to be followed in the study for 12 months. Procedural/acute outcomes&#xD;
      and clinical outcomes will be assessed at procedure, 30 days, 6 and 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 29, 2019</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>In-stent (in balloon) Late Lumen Loss (LLL) as measured by Quantitative coronary angiography (QCA) at six months</measure>
    <time_frame>At 6 months follow up</time_frame>
    <description>The average 6 months in-stent (in-balloon) LLL will be compared to a maximum acceptance rate. If in-stent (in-balloon) LLL is less than the maximum acceptance rate, then the trial will be considered to have met the primary endpoint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All deaths including cardiac death.procedure</measure>
    <time_frame>30 days, 6 months and 1 year after procedure</time_frame>
    <description>Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Vessel Myocardial Infarction (TVMI)</measure>
    <time_frame>30 days, 6 months and 1 year after procedure</time_frame>
    <description>Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac event (MACE) defined as composite of death, Myocardial infarction (MI), emergent Coronary Artery Bypass Graft (CABG) or repeat Target lesion revascularization (TLR) (clinically driven) by percutaneous or surgical methods</measure>
    <time_frame>30 days, 6 months and 1 year after procedure</time_frame>
    <description>Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel failure (TVF) defined as cardiac death, TVMI, or clinically-driven Target vessel revascularization (TVR) by percutaneous or surgical methods.</measure>
    <time_frame>30 days, 6 months and 1 year after procedure</time_frame>
    <description>Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5. Target lesion failure (TLF) defined by a composite of cardiac death, TVMI, or clinically-driven TLR by percutaneous or surgical methods.</measure>
    <time_frame>30 days, 6 months and 1 year after procedure</time_frame>
    <description>Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All revascularizations (TLR, TVR and non-TVR).</measure>
    <time_frame>30 days, 6 months and 1 year after procedure</time_frame>
    <description>Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Thrombosis rate as defined as definite, probable, possible, and overall stent thrombosis (according to Academic Research Consortium definition).</measure>
    <time_frame>30 days, 6 months and 1 year after procedure</time_frame>
    <description>Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute success (device, lesion and procedure success).</measure>
    <time_frame>30 days, 6 months and 1 year after procedure</time_frame>
    <description>Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure</description>
  </secondary_outcome>
  <other_outcome>
    <measure>In-stent (balloon) and in-segment LLL</measure>
    <time_frame>6 months post-procedure</time_frame>
    <description>Angiographic Endpoints to be assessed at 6 months post-procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>In-stent (balloon) and in-segment percent diameter stenosis (%DS (Percent diameter stenosis)).</measure>
    <time_frame>6 months post-procedure</time_frame>
    <description>Angiographic Endpoints to be assessed at 6 months post-procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>In-stent (balloon) and in-segment Binary Angiographic Restenosis (BAR) rate [defined as ≥50% diameter stenosis (DS)].</measure>
    <time_frame>6 months post-procedure</time_frame>
    <description>Angiographic Endpoints to be assessed at 6 months post-procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>In-stent (balloon) and in-segment Minimum luminal/lumen diameter (MLD).</measure>
    <time_frame>6 months post-procedure</time_frame>
    <description>Angiographic Endpoints to be assessed at 6 months post-procedure</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>In-stent Restenosis</condition>
  <condition>Ischemic Heart Disease</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Treatment arm (Mdt Drug-Coated Balloon)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medtronic Coronary Drug-Coated Balloon Catheter used for dilatation of the target lesion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medtronic Coronary Drug-Coated Balloon Catheter</intervention_name>
    <description>Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty</description>
    <arm_group_label>Treatment arm (Mdt Drug-Coated Balloon)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria&#xD;
&#xD;
          -  Subject with documented stable or unstable angina, and/or clinical evidence of&#xD;
             ischemia&#xD;
&#xD;
          -  Subject is an acceptable candidate for treatment with a Coronary Drug- Coated Balloon&#xD;
             in accordance with the applicable guidelines on percutaneous coronary interventions,&#xD;
             manufacturer's Instructions for Use and the Declaration of Helsinki.&#xD;
&#xD;
        Key Exclusion Criteria&#xD;
&#xD;
          -  Acute Myocardial Infarction within the previous 72 hours&#xD;
&#xD;
          -  Planned treatment involves a bifurcation&#xD;
&#xD;
          -  Three vessel disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ZNA Middelheim</name>
      <address>
        <city>Antwerp</city>
        <zip>2020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Liege</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Donato</name>
      <address>
        <city>Milano</city>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze Lieve Vrouwe Gasthuis</name>
      <address>
        <city>Amsterdam</city>
        <zip>1091 AC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haga Ziekenhuis locatie Leyweg</name>
      <address>
        <city>Den Haag</city>
        <zip>2545 AA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3435 CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isala Klinieken</name>
      <address>
        <city>Zwolle</city>
        <zip>8025 AB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Italy</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>September 27, 2019</last_update_submitted>
  <last_update_submitted_qc>September 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2019</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>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Heart 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/NCT03260517
org study id: MDT17027DCB001
nct id: NCT03260517
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon
      Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis
      with coronary lesions previously treated with drug-eluting or bare metal stents in native
      coronary arteries.
This study is a prospective, pre-market, multi-center, single arm study evaluating up to 50
      subjects with symptoms of ischemic heart disease attributable to stenotic lesions of the
      coronary arteries that are amenable to treatment with the Medtronic Coronary Drug-Coated
      Balloon Catheter.

      Patients with de novo lesions, In-Stent Restenosis or small vessel disease who qualify for
      percutaneous coronary interventions treatable with the device with a diameter between 2.0 mm
      to 4.0 mm and a length ≤25 mm will be screened and are intended to participate in this study.

      Each subject is expected to be followed in the study for 12 months. Procedural/acute outcomes
      and clinical outcomes will be assessed at procedure, 30 days, 6 and 12 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: In-stent (in balloon) Late Lumen Loss (LLL) as measured by Quantitative coronary angiography (QCA) at six months
time frame: At 6 months follow up
description: The average 6 months in-stent (in-balloon) LLL will be compared to a maximum acceptance rate. If in-stent (in-balloon) LLL is less than the maximum acceptance rate, then the trial will be considered to have met the primary endpoint.
measure: All deaths including cardiac death.procedure
time frame: 30 days, 6 months and 1 year after procedure
description: Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
measure: Target Vessel Myocardial Infarction (TVMI)
time frame: 30 days, 6 months and 1 year after procedure
description: Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
measure: Major adverse cardiac event (MACE) defined as composite of death, Myocardial infarction (MI), emergent Coronary Artery Bypass Graft (CABG) or repeat Target lesion revascularization (TLR) (clinically driven) by percutaneous or surgical methods
time frame: 30 days, 6 months and 1 year after procedure
description: Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures
measure: Target vessel failure (TVF) defined as cardiac death, TVMI, or clinically-driven Target vessel revascularization (TVR) by percutaneous or surgical methods.
time frame: 30 days, 6 months and 1 year after procedure
description: Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures
measure: 5. Target lesion failure (TLF) defined by a composite of cardiac death, TVMI, or clinically-driven TLR by percutaneous or surgical methods.
time frame: 30 days, 6 months and 1 year after procedure
description: Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
measure: All revascularizations (TLR, TVR and non-TVR).
time frame: 30 days, 6 months and 1 year after procedure
description: Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
measure: Stent Thrombosis rate as defined as definite, probable, possible, and overall stent thrombosis (according to Academic Research Consortium definition).
time frame: 30 days, 6 months and 1 year after procedure
description: Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
measure: Acute success (device, lesion and procedure success).
time frame: 30 days, 6 months and 1 year after procedure
description: Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
measure: In-stent (balloon) and in-segment LLL
time frame: 6 months post-procedure
description: Angiographic Endpoints to be assessed at 6 months post-procedure
measure: In-stent (balloon) and in-segment percent diameter stenosis (%DS (Percent diameter stenosis)).
time frame: 6 months post-procedure
description: Angiographic Endpoints to be assessed at 6 months post-procedure
measure: In-stent (balloon) and in-segment Binary Angiographic Restenosis (BAR) rate [defined as ≥50% diameter stenosis (DS)].
time frame: 6 months post-procedure
description: Angiographic Endpoints to be assessed at 6 months post-procedure
measure: In-stent (balloon) and in-segment Minimum luminal/lumen diameter (MLD).
time frame: 6 months post-procedure
description: Angiographic Endpoints to be assessed at 6 months post-procedure
arm group label: Treatment arm (Mdt Drug-Coated Balloon)
arm group type: Experimental
description: Medtronic Coronary Drug-Coated Balloon Catheter used for dilatation of the target lesion.
intervention type: Device
intervention name: Medtronic Coronary Drug-Coated Balloon Catheter
description: Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty
arm group label: Treatment arm (Mdt Drug-Coated Balloon)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Italy
country: Netherlands
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Heart Diseases
sharing ipd: Undecided