<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/NCT02996318</url>
  </required_header>
  <id_info>
    <org_study_id>SI01</org_study_id>
    <nct_id>NCT02996318</nct_id>
  </id_info>
  <brief_title>Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon</brief_title>
  <acronym>FIMLIMUSDCB</acronym>
  <official_title>Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to investigate the non-inferiority of the new sirolimus-coated&#xD;
      balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance,&#xD;
      safety and efficacy in coronary DES in-stent restenosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to investigate the non-inferiority of the new sirolimus-coated&#xD;
      balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance,&#xD;
      safety and efficacy in coronary DES in-stent restenosis.&#xD;
&#xD;
      Patient population will consist of male and female adults suffering from coronary&#xD;
      drug-eluting stent (DES) restenosis, which is to be treated by a study balloon according to&#xD;
      the inclusion and exclusion criteria as defined below.&#xD;
&#xD;
      In Late lumen loss lesion (difference between the angiographic in-lesion MLD post procedural&#xD;
      and at 6 months follow-up) will be evaluated by quantitative coronary angiography (QCA).&#xD;
&#xD;
      The study will be performed as a single-blind, SQP controlled study in 4 - 6 study centers in&#xD;
      50 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2015</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Late lumen loss</measure>
    <time_frame>6 months</time_frame>
    <description>Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedural Success</measure>
    <time_frame>24 hours</time_frame>
    <description>≤ 30% final stenosis, TIMI III flow, no flow-limiting dissection at the conclusion of the procedure, and the absence of in-hospital (24 hour after treatment) MACE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACE (Major adverse cardiac events)</measure>
    <time_frame>12 months</time_frame>
    <description>MACE will be defined as the occurrence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months and 12 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>DES In-stent Stenosis</condition>
  <arm_group>
    <arm_group_label>Sirolimus coated Balloon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treatment of coronary DES-ISR with a sirolimus coated balloon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paclitaxel coated balloon (SeQuent Please)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>treatment of coronary DES-ISR with a paclitaxel coated balloon</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Paclitaxel coated balloon (SeQuent Please)</intervention_name>
    <description>Paclitaxel coated balloon (SeQuent Please)</description>
    <arm_group_label>Paclitaxel coated balloon (SeQuent Please)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sirolimus coated balloon</intervention_name>
    <description>Sirolimus coated balloon</description>
    <arm_group_label>Sirolimus 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 drug-eluting stent in-stent restenosis (DES-ISR) lesions (≥&#xD;
             70% diameter stenosis by visual estimation or ≥ 50% and positive functional study)&#xD;
             including margin stenosis with max 5mm 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, 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>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital II</name>
      <address>
        <city>Kota Kinabalu</city>
        <zip>88300</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Heart Institute</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>50400</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Malaya</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>50603</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarawak Genaral Hospital Heart Centre</name>
      <address>
        <city>Kuching</city>
        <zip>94300</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pulau Pinang</name>
      <address>
        <city>Pulau Pinang</city>
        <zip>10990</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</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>
  <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/NCT02996318
org study id: SI01
nct id: NCT02996318
lead sponsor: 
has dmc: Yes
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated
      balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance,
      safety and efficacy in coronary DES in-stent restenosis.
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated
      balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance,
      safety and efficacy in coronary DES in-stent restenosis.

      Patient population will consist of male and female adults suffering from coronary
      drug-eluting stent (DES) restenosis, which is to be treated by a study balloon according to
      the inclusion and exclusion criteria as defined below.

      In Late lumen loss lesion (difference between the angiographic in-lesion MLD post procedural
      and at 6 months follow-up) will be evaluated by quantitative coronary angiography (QCA).

      The study will be performed as a single-blind, SQP controlled study in 4 - 6 study centers in
      50 patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Late lumen loss
time frame: 6 months
description: Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI
measure: Procedural Success
time frame: 24 hours
description: ≤ 30% final stenosis, TIMI III flow, no flow-limiting dissection at the conclusion of the procedure, and the absence of in-hospital (24 hour after treatment) MACE
measure: MACE (Major adverse cardiac events)
time frame: 12 months
description: MACE will be defined as the occurrence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months and 12 months.
arm group label: Sirolimus coated Balloon
arm group type: Experimental
description: treatment of coronary DES-ISR with a sirolimus coated balloon
arm group label: Paclitaxel coated balloon (SeQuent Please)
arm group type: Active Comparator
description: treatment of coronary DES-ISR with a paclitaxel coated balloon
intervention type: Device
intervention name: Paclitaxel coated balloon (SeQuent Please)
description: Paclitaxel coated balloon (SeQuent Please)
arm group label: Paclitaxel coated balloon (SeQuent Please)
intervention type: Device
intervention name: Sirolimus coated balloon
description: Sirolimus coated balloon
arm group label: Sirolimus coated Balloon
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Malaysia
responsible party type: Sponsor
mesh term: Sirolimus
mesh term: Paclitaxel
sharing ipd: No