<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/NCT03242096</url>
  </required_header>
  <id_info>
    <org_study_id>SI-ISR-01</org_study_id>
    <nct_id>NCT03242096</nct_id>
  </id_info>
  <brief_title>Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon</brief_title>
  <official_title>Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated SEQUENT® SCB RAPID EXCHANGE PTCA Balloon Catheter or a Paclitaxel Coated SEQUENT® PLEASE PTCA Balloon Catheter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InnoRa GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InnoRa GmbH</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>
      Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID&#xD;
      EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experimental intervention: Predilatation of coronary ISR with POBA followed by a sirolimus&#xD;
      coated SeQuent®SCB balloon balloon (sirolimus 4.0 μg/mm²)&#xD;
&#xD;
      Control intervention: Predilatation of coronary ISR with POBA followed by a paclitaxel coated&#xD;
      SeQuent®Please balloon or SeQuent®Please NEO balloon (paclitaxel 3.0 μg/mm²)&#xD;
&#xD;
      Duration of intervention per patient: minutes&#xD;
&#xD;
      Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months clinical&#xD;
      follow up&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2017</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Experimental intervention: Predilatation of coronary ISR with POBA followed by a sirolimus coated SeQuent® SCB balloon balloon (sirolimus 4.0 μg/mm²)&#xD;
Control intervention: Predilatation of coronary ISR with POBA followed by a paclitaxel coated SeQuent® Please balloon or SeQuent® Please NEO balloon (paclitaxel 3.0 μg/mm²)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Blinded QCA for primary outcome</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>late lumen loss in-lesion at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>late lumen loss in-lesion at 6 months assessed by blinded QCA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedural Success</measure>
    <time_frame>during hospital stay of index procedure</time_frame>
    <description>&lt; 30% final stenosis, TIMI III flow, no flow-limiting dissection, and the absence of in-hospital MACE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACE</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual clinical endpoints</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, binary restenosis (stenosis ≥ 50% at follow-up angiography)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Coronary Restenosis</condition>
  <arm_group>
    <arm_group_label>Sirolimus coated balloon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment of in-stent restenosis with a sirolimus coated balloon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paclitaxel coated balloon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment of in-stent restenosis with a paclitaxel coated balloon</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Sirolimus coated balloon</intervention_name>
    <description>Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a sirolimus coated balloon (SeQuent®SCB balloon with sirolimus 4.0 μg/mm²)</description>
    <arm_group_label>Sirolimus coated balloon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Paclitaxel coated balloon</intervention_name>
    <description>Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a paclitaxel coated balloon (SeQuent®Please balloon or SeQuent®Please NEO balloon with paclitaxel 3.0 μg/mm²) (paclitaxel 3.0 μg/mm²)</description>
    <arm_group_label>Paclitaxel coated balloon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age&#xD;
&#xD;
          -  Clinical evidence of stable or unstable angina (acute coronary syndrome) or a positive&#xD;
             functional study&#xD;
&#xD;
          -  Patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis&#xD;
             by visual estimation or ≥50% and positive functional study) including margin-stenosis&#xD;
             with max 5 mm distance to the stent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic renal insufficiency with serum creatinine levels &gt; 2.0 mg per deciliter&#xD;
&#xD;
          -  Known hypersensitivity or contraindications to aspirin, heparin, clopidogrel,&#xD;
             ticlopidine or sirolimus, and sensitivity to contrast media not amenable to&#xD;
             premedication&#xD;
&#xD;
          -  Concomitant medical illness associated with a life-expectancy of less than two year&#xD;
&#xD;
          -  Lesion length (ISR) &gt; 35 mm, reference vessel diameter &lt; 2.5 mm&#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>Bruno Scheller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Saarland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical and Experimental Interventional Cardiology</name>
      <address>
        <city>Homburg</city>
        <state>Saarland</state>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Innere Medizin und Kardiologie</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deutsches Zentrum für Herz und Kreislauf</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Internal Medicine II</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.</citation>
    <PMID>17101615</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 24, 2021</last_update_submitted>
  <last_update_submitted_qc>August 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2021</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 Restenosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sirolimus</mesh_term>
    <mesh_term>Paclitaxel</mesh_term>
  </intervention_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/NCT03242096
org study id: SI-ISR-01
nct id: NCT03242096
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID
      EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter
Experimental intervention: Predilatation of coronary ISR with POBA followed by a sirolimus
      coated SeQuent®SCB balloon balloon (sirolimus 4.0 μg/mm²)

      Control intervention: Predilatation of coronary ISR with POBA followed by a paclitaxel coated
      SeQuent®Please balloon or SeQuent®Please NEO balloon (paclitaxel 3.0 μg/mm²)

      Duration of intervention per patient: minutes

      Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months clinical
      follow up
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Experimental intervention: Predilatation of coronary ISR with POBA followed by a sirolimus coated SeQuent® SCB balloon balloon (sirolimus 4.0 μg/mm²)
Control intervention: Predilatation of coronary ISR with POBA followed by a paclitaxel coated SeQuent® Please balloon or SeQuent® Please NEO balloon (paclitaxel 3.0 μg/mm²)
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Blinded QCA for primary outcome
measure: late lumen loss in-lesion at 6 months
time frame: 6 months
description: late lumen loss in-lesion at 6 months assessed by blinded QCA
measure: Procedural Success
time frame: during hospital stay of index procedure
description: < 30% final stenosis, TIMI III flow, no flow-limiting dissection, and the absence of in-hospital MACE
measure: MACE
time frame: 6 and 12 months
description: cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization
measure: Individual clinical endpoints
time frame: 6 and 12 months
description: stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, binary restenosis (stenosis ≥ 50% at follow-up angiography)
arm group label: Sirolimus coated balloon
arm group type: Experimental
description: Treatment of in-stent restenosis with a sirolimus coated balloon
arm group label: Paclitaxel coated balloon
arm group type: Active Comparator
description: Treatment of in-stent restenosis with a paclitaxel coated balloon
intervention type: Combination Product
intervention name: Sirolimus coated balloon
description: Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a sirolimus coated balloon (SeQuent®SCB balloon with sirolimus 4.0 μg/mm²)
arm group label: Sirolimus coated balloon
intervention type: Combination Product
intervention name: Paclitaxel coated balloon
description: Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a paclitaxel coated balloon (SeQuent®Please balloon or SeQuent®Please NEO balloon with paclitaxel 3.0 μg/mm²) (paclitaxel 3.0 μg/mm²)
arm group label: Paclitaxel coated balloon
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bruno Scheller, MD
role: Principal Investigator
affiliation: University of Saarland
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Switzerland
citation: Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.
PMID: 17101615
responsible party type: Sponsor
mesh term: Coronary Restenosis
mesh term: Sirolimus
mesh term: Paclitaxel
sharing ipd: No