<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/NCT04470934</url>
  </required_header>
  <id_info>
    <org_study_id>AAG-O-H-1913</org_study_id>
    <nct_id>NCT04470934</nct_id>
  </id_info>
  <brief_title>SeQuent® SCB &quot;All Comers&quot; Post Market Clinical Follow-up (PMCF)</brief_title>
  <acronym>SCORE</acronym>
  <official_title>PMCF - Study on the Performance/Safety of SeQuent® Sirolimus-Coated Balloon (SCB, Investigational Device) in Patients With Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>B. Braun Melsungen AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>B. Braun Melsungen AG</source>
  <oversight_info>
    <has_dmc>No</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>
      The aim of the study is to assess continued safety and efficacy of the SeQuent® SCB. The&#xD;
      product under investigation will be used in routine clinical practice according to the latest&#xD;
      European Society of Cardiology (ESC) guidelines and according to the Instructions for Use&#xD;
      (IFU). Those data that are obtained in routine clinical use will be documented in the Case&#xD;
      Report Form (CRF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the study is to assess the continued safety and efficacy of SeQuent® SCB for&#xD;
      the treatment of &quot;real world&quot; de-novo and restenotic lesions in native coronary arteries and&#xD;
      coronary bypass grafts. Study goals are based on non-inferiority for Drug-Coated Balloon&#xD;
      (DCB) compared to Paclitaxel-Coated Balloon (PCB) and Dru-eluting Stents (DES) (historical&#xD;
      data) with 80% power. Primary and secondary outcome variables are international accepted&#xD;
      parameters in stent-trials, which sufficiently describe the efficacy and safety of the&#xD;
      investigated device and allow clinical conclusions. Additional attention will be paid to&#xD;
      those patients who received, by observation, a shortened dual antiplatelet therapy (DAPT).&#xD;
&#xD;
      The aim of the study is to assess the safety and efficacy of the SeQuent® SCB in the&#xD;
      treatment of coronary artery disease with reference vessel diameters between ≥ 2 mm and ≤ 4&#xD;
      mm with suitable lesion lengths. There is no limitation of lesion lengths. In case the lesion&#xD;
      is longer than 34 mm, more than one stent needs to be used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 30, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Target Lesion Failure (TLF)</measure>
    <time_frame>at 12 months</time_frame>
    <description>Target Lesion Failure (TLF): defined as the composite rate of target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Failure (TLF)</measure>
    <time_frame>at 24 months</time_frame>
    <description>Target Lesion Failure (TLF): defined as the composite rate of target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ischemia driven target lesion revascularization (TLR)</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ischemia driven target lesion revascularization (TLR)</measure>
    <time_frame>at 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>all-cause death, cardiac death</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>all-cause death, cardiac death</measure>
    <time_frame>at 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)</measure>
    <time_frame>at 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>major adverse coronary event (MACE)</measure>
    <time_frame>at 12 months</time_frame>
    <description>major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>major adverse coronary event (MACE)</measure>
    <time_frame>at 24 months</time_frame>
    <description>major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dual Antiplatelet Therapy (DAPT) compliance</measure>
    <time_frame>at 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dual Antiplatelet Therapy (DAPT) compliance</measure>
    <time_frame>at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probable or definite stent-thrombosis of In-stent treated lesions</measure>
    <time_frame>accumulated at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probable or definite stent-thrombosis of In-stent treated lesions</measure>
    <time_frame>accumulated at 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural success</measure>
    <time_frame>immediately after procedure</time_frame>
    <description>final diameter stenosis &lt; 30 % without flow-limiting dissections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding complications according to the Bleeding Academic Research Consortium (BARC)</measure>
    <time_frame>accumulated at 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding complications according to the Bleeding Academic Research Consortium (BARC)</measure>
    <time_frame>accumulated at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding complications according to the Bleeding Academic Research Consortium (BARC)</measure>
    <time_frame>accumulated at 24 months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">1302</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Myocardial Ischaemia</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SeQuent® SCB drug-coated balloon catheter</intervention_name>
    <description>treatment of coronary artery disease with SeQuent® SCB of &quot;real world&quot; de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This is a single-armed, prospective, international, multi-center, post-market study in&#xD;
        patients with coronary artery disease and indication for PCI either due to anginal symptoms&#xD;
        and a relevant stenotic coronary lesion during angiography or due to documented ischemia by&#xD;
        non-invasive or invasive functional testing.&#xD;
&#xD;
        All patients who undergo a target intervention with the SCB will be followed for 12 and 24&#xD;
        months after initial PCI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All common significant coronary lesions&#xD;
&#xD;
          -  Target lesion length &gt;34mm need to be covered with at least 2 devices&#xD;
&#xD;
          -  Patients eligible for this study must be at least 18 years of age&#xD;
&#xD;
          -  The patient must fulfil the standard recommendations for percutaneous coronary&#xD;
             intervention (PCI), based on the last ESC recommendations within his/ her regular&#xD;
             treatment or that the use of the product has already been decided within the regular&#xD;
             planning of the patient's treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intolerance to sirolimus&#xD;
&#xD;
          -  Allergy to components of the coating&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
&#xD;
          -  Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Risk of an intraluminal thrombus&#xD;
&#xD;
          -  Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or&#xD;
             cerebral circulatory disorders which restrict the use of platelet aggregation&#xD;
             inhibitor therapy and anti-coagulation therapy&#xD;
&#xD;
          -  Surgery shortly after myocardial infarction with indications of thrombus or poor&#xD;
             coronary flow behavior&#xD;
&#xD;
          -  Severe allergy to contrast media&#xD;
&#xD;
          -  Lesions which are untreatable with PCI or other interventional techniques&#xD;
&#xD;
          -  Patients with an ejection fraction of &lt; 30 %&#xD;
&#xD;
          -  Vascular reference diameter &lt; 2.00 mm&#xD;
&#xD;
          -  Treatment of the left stem (first section of the left coronary artery)&#xD;
&#xD;
          -  Indication for a bypass surgery&#xD;
&#xD;
          -  Contraindication for whichever accompanying medication is necessary&#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>Sylvia Otto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Jena - Klinik für Innere Medizin I</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sylvia Otto, MD</last_name>
    <phone>+49 3641 932 45 60</phone>
    <email>Sylvia.Otto@med.uni-jena.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universitätsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <state>Thüringen</state>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sylvia Otto, MD</last_name>
      <phone>+49 3641 932 45 60</phone>
      <email>Sylvia.Otto@med.uni-jena.de</email>
    </contact>
    <investigator>
      <last_name>Sylvia Otto, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Myocardial Ischemia</keyword>
  <keyword>drug-coated balloon catheter</keyword>
  <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>Coronary Disease</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04470934
org study id: AAG-O-H-1913
nct id: NCT04470934
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to assess continued safety and efficacy of the SeQuent® SCB. The
      product under investigation will be used in routine clinical practice according to the latest
      European Society of Cardiology (ESC) guidelines and according to the Instructions for Use
      (IFU). Those data that are obtained in routine clinical use will be documented in the Case
      Report Form (CRF).
The objective of the study is to assess the continued safety and efficacy of SeQuent® SCB for
      the treatment of "real world" de-novo and restenotic lesions in native coronary arteries and
      coronary bypass grafts. Study goals are based on non-inferiority for Drug-Coated Balloon
      (DCB) compared to Paclitaxel-Coated Balloon (PCB) and Dru-eluting Stents (DES) (historical
      data) with 80% power. Primary and secondary outcome variables are international accepted
      parameters in stent-trials, which sufficiently describe the efficacy and safety of the
      investigated device and allow clinical conclusions. Additional attention will be paid to
      those patients who received, by observation, a shortened dual antiplatelet therapy (DAPT).

      The aim of the study is to assess the safety and efficacy of the SeQuent® SCB in the
      treatment of coronary artery disease with reference vessel diameters between ≥ 2 mm and ≤ 4
      mm with suitable lesion lengths. There is no limitation of lesion lengths. In case the lesion
      is longer than 34 mm, more than one stent needs to be used.
observational model: Other
time perspective: Prospective
measure: Target Lesion Failure (TLF)
time frame: at 12 months
description: Target Lesion Failure (TLF): defined as the composite rate of target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR).
measure: Target Lesion Failure (TLF)
time frame: at 24 months
description: Target Lesion Failure (TLF): defined as the composite rate of target vessel myocardial infarction (TV-MI) or ischemia-driven target lesion revascularization (TLR).
measure: ischemia driven target lesion revascularization (TLR)
time frame: at 12 months
measure: ischemia driven target lesion revascularization (TLR)
time frame: at 24 months
measure: all-cause death, cardiac death
time frame: at 12 months
measure: all-cause death, cardiac death
time frame: at 24 months
measure: all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)
time frame: at 12 months
measure: all myocardial infarction (MI) and target vessel myocardial infarction (TV-MI)
time frame: at 24 months
measure: major adverse coronary event (MACE)
time frame: at 12 months
description: major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization
measure: major adverse coronary event (MACE)
time frame: at 24 months
description: major adverse coronary event (MACE): defined as composite of cardiovascular death, myocardial infarction or ischemia-driven target lesion revascularization
measure: Dual Antiplatelet Therapy (DAPT) compliance
time frame: at 4 weeks
measure: Dual Antiplatelet Therapy (DAPT) compliance
time frame: at 3 months
measure: Probable or definite stent-thrombosis of In-stent treated lesions
time frame: accumulated at 12 months
measure: Probable or definite stent-thrombosis of In-stent treated lesions
time frame: accumulated at 24 months
measure: Procedural success
time frame: immediately after procedure
description: final diameter stenosis < 30 % without flow-limiting dissections
measure: Bleeding complications according to the Bleeding Academic Research Consortium (BARC)
time frame: accumulated at 3 months
measure: Bleeding complications according to the Bleeding Academic Research Consortium (BARC)
time frame: accumulated at 12 months
measure: Bleeding complications according to the Bleeding Academic Research Consortium (BARC)
time frame: accumulated at 24 months
intervention type: Device
intervention name: SeQuent® SCB drug-coated balloon catheter
description: treatment of coronary artery disease with SeQuent® SCB of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sylvia Otto, MD
role: Principal Investigator
affiliation: Universitätsklinikum Jena - Klinik für Innere Medizin I
last name: Sylvia Otto, MD
phone: +49 3641 932 45 60
email: Sylvia.Otto@med.uni-jena.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Ischemia
sharing ipd: No