<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/NCT01690572</url>
  </required_header>
  <id_info>
    <org_study_id>DEBT</org_study_id>
    <nct_id>NCT01690572</nct_id>
  </id_info>
  <brief_title>Drug Eluting Balloon for Prevention of Constrictive Remodeling</brief_title>
  <official_title>Drug Coated Balloon (DCB) for the Prevention of Constrictive Remodeling and Restenosis in Small Vessel Coronary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. med. Christoph Hehrlein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Herz-Zentrums Bad Krozingen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in&#xD;
      diffuse small vessel disease especially of diabetic patients. High restenosis rates after&#xD;
      balloon only procedures in small vessels occur due to negative constrictive vessel remodeling&#xD;
      if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not&#xD;
      indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral&#xD;
      arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT&#xD;
      FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after&#xD;
      dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA)&#xD;
      using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive&#xD;
      remodelling process will be measured by optical coherence tomography (OCT) at 9 months median&#xD;
      F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    recruitment was not sufficient.&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MACE-rate</measure>
    <time_frame>12 months after initial treatment</time_frame>
    <description>combined end-point: death, myocardial infarction and revascularisation of the target lesion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OCT-measurement</measure>
    <time_frame>during follow-up, after 9 months</time_frame>
    <description>each symptomatic patient will be examined using optical coherence tomography to detect, if the symptoms are caused by a narrowing at the target lesion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Coronary Disease</condition>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Paclitaxel coated balloon catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Paclitaxel coated balloon catheter &quot;IN.PACT Falcon&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>uncoated balloon catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>uncoated balloon catheter &quot;sprinter legend&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Paclitaxel coated balloon catheter</intervention_name>
    <description>Dilatation of the target lesion</description>
    <arm_group_label>Paclitaxel coated balloon catheter</arm_group_label>
    <other_name>IN.PACT Falcon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>uncoated balloon catheter &quot;sprinter legend&quot;</intervention_name>
    <description>Dilatation of the target lesion</description>
    <arm_group_label>uncoated balloon catheter</arm_group_label>
    <other_name>sprinter legend</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least one target lesion with a stenosis severity ≥ 50% in one coronary segment with&#xD;
             a diameter ≤ 2.5 mm&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  weight &gt; 45 kg&#xD;
&#xD;
          -  patient suitable for balloon dilatation and not suitable for elective implantation of&#xD;
             a drug eluting stent&#xD;
&#xD;
          -  insulin-dependent or non-insulin-dependent diabetes mellitus&#xD;
&#xD;
          -  length of lesion ≥ 15 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy &lt; 12 months&#xD;
&#xD;
          -  In-Stent restenosis&#xD;
&#xD;
          -  planned coronary bypass or heart valve OP&#xD;
&#xD;
          -  ST elevation myocardial infarction within the last 72 hours&#xD;
&#xD;
          -  cardiogenic shock&#xD;
&#xD;
          -  renal impairment or liver dysfunction (creatinine &gt; 2.0 mg/dl, AST/ALT &gt; 3x of normal&#xD;
             value&#xD;
&#xD;
          -  incompliance&#xD;
&#xD;
          -  pregnant or breastfeeding women or women who like to be pregnant&#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>Christoph Hehrlein, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology and Angiology I, Heart Center, Freiburg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Cardiology and Angiology I, Heart Center,</name>
      <address>
        <city>Freiburg</city>
        <state>Baden-Württemberg</state>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>April 27, 2017</last_update_submitted>
  <last_update_submitted_qc>April 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Herz-Zentrums Bad Krozingen</investigator_affiliation>
    <investigator_full_name>Prof. Dr. med. Christoph Hehrlein</investigator_full_name>
    <investigator_title>Professor Dr. med.</investigator_title>
  </responsible_party>
  <keyword>drug eluting balloon</keyword>
  <keyword>constrictive remodeling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01690572
org study id: DEBT
nct id: NCT01690572
lead sponsor: 
has dmc: No
Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in
      diffuse small vessel disease especially of diabetic patients. High restenosis rates after
      balloon only procedures in small vessels occur due to negative constrictive vessel remodeling
      if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not
      indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral
      arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT
      FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after
      dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA)
      using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive
      remodelling process will be measured by optical coherence tomography (OCT) at 9 months median
      F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MACE-rate
time frame: 12 months after initial treatment
description: combined end-point: death, myocardial infarction and revascularisation of the target lesion
measure: OCT-measurement
time frame: during follow-up, after 9 months
description: each symptomatic patient will be examined using optical coherence tomography to detect, if the symptoms are caused by a narrowing at the target lesion
arm group label: Paclitaxel coated balloon catheter
arm group type: Active Comparator
description: Paclitaxel coated balloon catheter "IN.PACT Falcon"
arm group label: uncoated balloon catheter
arm group type: Active Comparator
description: uncoated balloon catheter "sprinter legend"
intervention type: Device
intervention name: Paclitaxel coated balloon catheter
description: Dilatation of the target lesion
arm group label: Paclitaxel coated balloon catheter
other name: IN.PACT Falcon
intervention type: Device
intervention name: uncoated balloon catheter "sprinter legend"
description: Dilatation of the target lesion
arm group label: uncoated balloon catheter
other name: sprinter legend
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christoph Hehrlein, Prof. Dr.
role: Principal Investigator
affiliation: Department of Cardiology and Angiology I, Heart Center, Freiburg University
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Herz-Zentrums Bad Krozingen
investigator full name: Prof. Dr. med. Christoph Hehrlein
investigator title: Professor Dr. med.
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Paclitaxel
mesh term: Hyaluronic Acid