<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/NCT03023098</url>
  </required_header>
  <id_info>
    <org_study_id>DRECOREST1 - Jan 23rd 2013</org_study_id>
    <nct_id>NCT03023098</nct_id>
  </id_info>
  <brief_title>Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study</brief_title>
  <acronym>DRECOREST1</acronym>
  <official_title>Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helsinki University Central Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the use of drug-eluting balloons is&#xD;
      effective in the treatment of (re)stenosis in bypass vein grafts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Drug-eluting devices have proved beneficial in the treatment of stenosis in native coronary&#xD;
      and lower limb arteries. Stenosis and restenosis is a known problem in bypass vein grafts,&#xD;
      and drug-eluting devices might be beneficial in this field as well.&#xD;
&#xD;
      In the procedure a conventional balloon is passed through the stenosis which is then dilated.&#xD;
      After this patients are randomized before a second dilatation with either a conventional&#xD;
      balloon or a drug-coated balloon.&#xD;
&#xD;
      The stenosis is evaluated preoperatively and followed up by means of ultrasound by a vascular&#xD;
      technician. Follow-up will end at 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TLR (Target lesion revascularization)</measure>
    <time_frame>12 months</time_frame>
    <description>Any reintervention to the same lesion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Graft occlusion</measure>
    <time_frame>0-12 months</time_frame>
    <description>Occlusion of the bypass graft</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major amputation</measure>
    <time_frame>0-12 months</time_frame>
    <description>Above or below knee amputation of the treated leg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>0-12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Primary assisted patency</measure>
    <time_frame>0-12 months</time_frame>
    <description>Patency of the graft after TLR</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Peripheral Artery Occlusive Disease</condition>
  <condition>Peripheral Artery Restenosis</condition>
  <condition>Peripheral Artery Stenosis</condition>
  <arm_group>
    <arm_group_label>Drug-eluting balloon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional PTA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional PTA</intervention_name>
    <description>After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon</description>
    <arm_group_label>Conventional PTA</arm_group_label>
    <other_name>PTA (percutaneous transluminal angioplasty)</other_name>
    <other_name>Balloon angioplasty</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Drug-eluting balloon</intervention_name>
    <description>After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon</description>
    <arm_group_label>Drug-eluting balloon</arm_group_label>
    <other_name>DEB</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any venous bypass with stenosis warranting intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maarit Venermo, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Helsinki University Hospital, Dept. of Vascular Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helsinki University Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Maarit Venermo</investigator_full_name>
    <investigator_title>Professor of Vascular Surgery</investigator_title>
  </responsible_party>
  <keyword>Restenosis</keyword>
  <keyword>Drug-eluting balloon</keyword>
  <keyword>Vein graft</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constriction, Pathologic</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/NCT03023098
org study id: DRECOREST1 - Jan 23rd 2013
nct id: NCT03023098
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether the use of drug-eluting balloons is
      effective in the treatment of (re)stenosis in bypass vein grafts.
Drug-eluting devices have proved beneficial in the treatment of stenosis in native coronary
      and lower limb arteries. Stenosis and restenosis is a known problem in bypass vein grafts,
      and drug-eluting devices might be beneficial in this field as well.

      In the procedure a conventional balloon is passed through the stenosis which is then dilated.
      After this patients are randomized before a second dilatation with either a conventional
      balloon or a drug-coated balloon.

      The stenosis is evaluated preoperatively and followed up by means of ultrasound by a vascular
      technician. Follow-up will end at 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: TLR (Target lesion revascularization)
time frame: 12 months
description: Any reintervention to the same lesion.
measure: Graft occlusion
time frame: 0-12 months
description: Occlusion of the bypass graft
measure: Major amputation
time frame: 0-12 months
description: Above or below knee amputation of the treated leg
measure: Death
time frame: 0-12 months
measure: Primary assisted patency
time frame: 0-12 months
description: Patency of the graft after TLR
arm group label: Drug-eluting balloon
arm group type: Experimental
arm group label: Conventional PTA
arm group type: Active Comparator
intervention type: Device
intervention name: Conventional PTA
description: After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon
arm group label: Conventional PTA
other name: PTA (percutaneous transluminal angioplasty)
other name: Balloon angioplasty
intervention type: Device
intervention name: Drug-eluting balloon
description: After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon
arm group label: Drug-eluting balloon
other name: DEB
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Maarit Venermo, M.D., Ph.D.
role: Study Director
affiliation: Helsinki University Hospital, Dept. of Vascular Surgery
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Maarit Venermo
investigator title: Professor of Vascular Surgery
mesh term: Constriction, Pathologic
sharing ipd: No