<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/NCT02198105</url>
  </required_header>
  <id_info>
    <org_study_id>DEBTRAK-Registry</org_study_id>
    <nct_id>NCT02198105</nct_id>
  </id_info>
  <brief_title>Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.</brief_title>
  <acronym>DEBTRAK</acronym>
  <official_title>Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Caritasklinik St. Theresia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Caritasklinik St. Theresia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational registry including patients with peripheral artery disease due to&#xD;
      femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent&#xD;
      drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The registry includes consecutive patients with symptomatic peripheral artery disease due to&#xD;
      femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent&#xD;
      drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).&#xD;
&#xD;
      Interventional procedure:&#xD;
&#xD;
        1. PTA with Cutting-Balloon (60-120 seconds).&#xD;
&#xD;
        2. PTA with Drug-Coated-Balloon (60 seconds).&#xD;
&#xD;
      Technical success is defined as&#xD;
&#xD;
        1. no recoil &gt;30%&#xD;
&#xD;
        2. no dissection &gt;Type B&#xD;
&#xD;
        3. no stenting &gt;30% of lesion length.&#xD;
&#xD;
      Follow-up of patients after 6 months and 12 months (ABI, Rutherford-classification, MACE,&#xD;
      TLR, TVR, Binary Restenosis).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">November 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Clinically driven target lesion revascularization (TLR)</measure>
    <time_frame>6 months</time_frame>
    <description>clinically driven target lesion revascularization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinically driven target vessel revascularization (TVR)</measure>
    <time_frame>6 months</time_frame>
    <description>TVR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binary restenosis</measure>
    <time_frame>6 months</time_frame>
    <description>Peak Systolic velocity (PSV) &gt;2.4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Ankle Brachial Index (ABI)</measure>
    <time_frame>6 months</time_frame>
    <description>Change in ankle brachial index from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Rutherford-classification</measure>
    <time_frame>6 months</time_frame>
    <description>Change in Rutherford-Classification from Baseline (I-VI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>major cardiac adverse events</measure>
    <time_frame>6 months</time_frame>
    <description>myocardial infarction, stroke, death, cardiovascular death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amputation</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinically driven target vessel revascularization (TVR)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically driven target lesion revascularization (TLR)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binary restenosis</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Ankle Brachial Index (ABI)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Rutherford-classification</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>major cardiac adverse events</measure>
    <time_frame>12 months</time_frame>
    <description>myocardial infarction, stroke, death, cardiovascular death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amputation</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <condition>Femoropoliteal Stenosis/Occlusion</condition>
  <condition>Cutting-balloon</condition>
  <condition>Drug-coated-balloon</condition>
  <arm_group>
    <arm_group_label>Femoropopliteal stenosis</arm_group_label>
    <description>Consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis/occlusion.&#xD;
Intervention with Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon-PTA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA</intervention_name>
    <description>Interventional procedure:&#xD;
PTA with Cutting-Balloon (60-120 seconds).&#xD;
PTA with DC-Balloon (60 seconds).&#xD;
Technical success is defined as&#xD;
no recoil &gt;30%&#xD;
no dissection &gt;Type B&#xD;
no stenting &gt;30% of lesion length.</description>
    <arm_group_label>Femoropopliteal stenosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or&#xD;
        occlusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  peripheral artery disease (PAD) with femoro-popliteal stenosis &gt;70% or occlusion&#xD;
             (vessel diameter 4-6mm)&#xD;
&#xD;
          -  age 18-99&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  proximal / iliacal stenosis&#xD;
&#xD;
          -  stenosis/occlusion of all arteries below the knee&#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>Magnus Baumhäkel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CaritasKlinikum, St. Theresia Saarbrücken, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CaritasKlinikum, St. Theresia</name>
      <address>
        <city>Saarbrücken</city>
        <state>Saarland</state>
        <zip>66113</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 21, 2016</last_update_submitted>
  <last_update_submitted_qc>July 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Caritasklinik St. Theresia</investigator_affiliation>
    <investigator_full_name>Magnus Baumhäkel</investigator_full_name>
    <investigator_title>PD Dr. med. Magnus Baumhäkel</investigator_title>
  </responsible_party>
  <keyword>PAD</keyword>
  <keyword>femoropoliteal stenosis/occlusion</keyword>
  <keyword>cutting-balloon</keyword>
  <keyword>drug-coated-balloon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_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/NCT02198105
org study id: DEBTRAK-Registry
nct id: NCT02198105
lead sponsor: 
has dmc: No
Observational registry including patients with peripheral artery disease due to
      femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent
      drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).
The registry includes consecutive patients with symptomatic peripheral artery disease due to
      femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent
      drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).

      Interventional procedure:

        1. PTA with Cutting-Balloon (60-120 seconds).

        2. PTA with Drug-Coated-Balloon (60 seconds).

      Technical success is defined as

        1. no recoil >30%

        2. no dissection >Type B

        3. no stenting >30% of lesion length.

      Follow-up of patients after 6 months and 12 months (ABI, Rutherford-classification, MACE,
      TLR, TVR, Binary Restenosis).
observational model: Cohort
time perspective: Prospective
measure: Clinically driven target lesion revascularization (TLR)
time frame: 6 months
description: clinically driven target lesion revascularization
measure: clinically driven target vessel revascularization (TVR)
time frame: 6 months
description: TVR
measure: Binary restenosis
time frame: 6 months
description: Peak Systolic velocity (PSV) >2.4
measure: Change in Ankle Brachial Index (ABI)
time frame: 6 months
description: Change in ankle brachial index from baseline.
measure: Change in Rutherford-classification
time frame: 6 months
description: Change in Rutherford-Classification from Baseline (I-VI)
measure: major cardiac adverse events
time frame: 6 months
description: myocardial infarction, stroke, death, cardiovascular death
measure: Amputation
time frame: 6 months
measure: clinically driven target vessel revascularization (TVR)
time frame: 12 months
measure: Clinically driven target lesion revascularization (TLR)
time frame: 12 months
measure: Binary restenosis
time frame: 12 months
measure: Change in Ankle Brachial Index (ABI)
time frame: 12 months
measure: Change in Rutherford-classification
time frame: 12 months
measure: major cardiac adverse events
time frame: 12 months
description: myocardial infarction, stroke, death, cardiovascular death
measure: Amputation
time frame: 12 months
arm group label: Femoropopliteal stenosis
description: Consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis/occlusion.
Intervention with Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon-PTA.
intervention type: Device
intervention name: Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA
description: Interventional procedure:
PTA with Cutting-Balloon (60-120 seconds).
PTA with DC-Balloon (60 seconds).
Technical success is defined as
no recoil >30%
no dissection >Type B
no stenting >30% of lesion length.
arm group label: Femoropopliteal stenosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Magnus Baumhäkel, MD
role: Principal Investigator
affiliation: CaritasKlinikum, St. Theresia Saarbrücken, Germany
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Caritasklinik St. Theresia
investigator full name: Magnus Baumhäkel
investigator title: PD Dr. med. Magnus Baumhäkel
mesh term: Peripheral Arterial Disease
mesh term: Constriction, Pathologic