<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/NCT02212470</url>
  </required_header>
  <id_info>
    <org_study_id>IDPC_3 2014</org_study_id>
    <nct_id>NCT02212470</nct_id>
  </id_info>
  <brief_title>Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery</brief_title>
  <acronym>PAVENST</acronym>
  <official_title>Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Dante Pazzanese de Cardiologia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Dante Pazzanese de Cardiologia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate whether the results of drug eluting balloon are&#xD;
      non-inferior to the Nitinol stent implantation in the femoropopliteal segment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">October 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>Phase 4</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>Prospective, randomized, single-center, single-blind, non-inferiority, clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary patency</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluations will be conducted after 3, 6 and 12 months of the procedure. The ultrasonographic evaluation of the degree of stenosis will use the Systolic Velocity Index (division of the velocity of flow at the point of greatest stenosis by the velocity of flow in normal prior segment). Rates higher than 2.4 indicate stenosis greater than 50%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rutherford classification</measure>
    <time_frame>12 months</time_frame>
    <description>Change in classification from Rutherford evaluated in 3, 6 and 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle braquial Index</measure>
    <time_frame>12 months</time_frame>
    <description>Change in the Ankle braquial Index evaluated in 3, 6 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Revascularization</measure>
    <time_frame>12 months</time_frame>
    <description>Target Lesion Revascularization rate evaluated in 3, 6 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent fracture</measure>
    <time_frame>12 months</time_frame>
    <description>Stent fracture rate evaluated in 3, 6 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amputation</measure>
    <time_frame>12 months</time_frame>
    <description>Major amputation defined as amputation that requires prosthesis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute myocardial infarct</measure>
    <time_frame>12 months</time_frame>
    <description>Acute myocardial infarct rate evaluated in 3, 6 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>12 months</time_frame>
    <description>Death rate evaluated in 3, 6 and 12 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Arterial Occlusive Diseases</condition>
  <condition>Atherosclerosis</condition>
  <condition>Arteriosclerosis</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Peripheral Vascular Diseases</condition>
  <condition>Paclitaxel</condition>
  <condition>Plaque, Atherosclerotic</condition>
  <condition>Critical Limb Ischemia</condition>
  <arm_group>
    <arm_group_label>Drug Eluting Balloon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Admiral In.Pact Drug Eluting Balloon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nitinol Stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Complete SE Self-expandible Nitinol stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Drug Eluting Balloon Angioplasty</intervention_name>
    <description>Angioplasty with Drug eluting balloon after pre dilatation</description>
    <arm_group_label>Drug Eluting Balloon</arm_group_label>
    <other_name>Medtronic</other_name>
    <other_name>Admiral In.Pact</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nitinol stenting</intervention_name>
    <description>Nitinol stent deployment</description>
    <arm_group_label>Nitinol Stent</arm_group_label>
    <other_name>Medtronic</other_name>
    <other_name>Complete SE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years with critical lower limb ischemia,&#xD;
&#xD;
          -  Ruhtherford 3 or higher,&#xD;
&#xD;
          -  with angiographic documentation of greater than 70% or occlusion in the superficial&#xD;
             femoral artery,&#xD;
&#xD;
          -  with a maximum extension of 10 cm stenosis.&#xD;
&#xD;
          -  The popliteal artery and at least one leg artery must be patent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy,&#xD;
&#xD;
          -  thrombophilia,&#xD;
&#xD;
          -  coagulation disorders,&#xD;
&#xD;
          -  presence of active or recent bleeding,&#xD;
&#xD;
          -  severe allergy to iodinated contrast,&#xD;
&#xD;
          -  renal or hepatic disease,&#xD;
&#xD;
          -  acute limb ischemia,&#xD;
&#xD;
          -  prior surgical bypass or angioplasty (with or without stent) on the target artery,&#xD;
&#xD;
          -  obstructive disease (stenosis&gt; 50%) of the aortoiliac segment ipsilateral to the&#xD;
             target (if the aortoiliac is pre-treated, the patient may be included)&#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 L ALMEIDA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Dante Pazzanese de Cardiologia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>FABIO H ROSSI, MD, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Instituto Dante Pazzanese de Cardiologia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Dante Pazzanese de Cardiologia</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04012909</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
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  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>June 8, 2021</last_update_submitted>
  <last_update_submitted_qc>June 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Dante Pazzanese de Cardiologia</investigator_affiliation>
    <investigator_full_name>Fabio H Rossi</investigator_full_name>
    <investigator_title>MD, PHD</investigator_title>
  </responsible_party>
  <keyword>Artery</keyword>
  <keyword>Atherosclerosis</keyword>
  <keyword>Peripheral</keyword>
  <keyword>Arterial</keyword>
  <keyword>Plaque</keyword>
  <keyword>PTA</keyword>
  <keyword>Angioplasty</keyword>
  <keyword>Femoropopliteal</keyword>
  <keyword>Self Expandable Nitinol Stents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Chronic Limb-Threatening Ischemia</mesh_term>
    <mesh_term>Arteriosclerosis</mesh_term>
    <mesh_term>Arterial Occlusive Diseases</mesh_term>
    <mesh_term>Plaque, Atherosclerotic</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/NCT02212470
org study id: IDPC_3 2014
nct id: NCT02212470
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate whether the results of drug eluting balloon are
      non-inferior to the Nitinol stent implantation in the femoropopliteal segment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized, single-center, single-blind, non-inferiority, clinical trial
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Primary patency
time frame: 12 months
description: Evaluations will be conducted after 3, 6 and 12 months of the procedure. The ultrasonographic evaluation of the degree of stenosis will use the Systolic Velocity Index (division of the velocity of flow at the point of greatest stenosis by the velocity of flow in normal prior segment). Rates higher than 2.4 indicate stenosis greater than 50%
measure: Rutherford classification
time frame: 12 months
description: Change in classification from Rutherford evaluated in 3, 6 and 12 months.
measure: Ankle braquial Index
time frame: 12 months
description: Change in the Ankle braquial Index evaluated in 3, 6 and 12 months
measure: Target Lesion Revascularization
time frame: 12 months
description: Target Lesion Revascularization rate evaluated in 3, 6 and 12 months
measure: Stent fracture
time frame: 12 months
description: Stent fracture rate evaluated in 3, 6 and 12 months
measure: Amputation
time frame: 12 months
description: Major amputation defined as amputation that requires prosthesis
measure: Acute myocardial infarct
time frame: 12 months
description: Acute myocardial infarct rate evaluated in 3, 6 and 12 months
measure: Death
time frame: 12 months
description: Death rate evaluated in 3, 6 and 12 months
arm group label: Drug Eluting Balloon
arm group type: Active Comparator
description: Admiral In.Pact Drug Eluting Balloon
arm group label: Nitinol Stent
arm group type: Active Comparator
description: Complete SE Self-expandible Nitinol stent
intervention type: Device
intervention name: Drug Eluting Balloon Angioplasty
description: Angioplasty with Drug eluting balloon after pre dilatation
arm group label: Drug Eluting Balloon
other name: Medtronic
other name: Admiral In.Pact
intervention type: Device
intervention name: Nitinol stenting
description: Nitinol stent deployment
arm group label: Nitinol Stent
other name: Medtronic
other name: Complete SE
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: BRUNO L ALMEIDA, MD
role: Principal Investigator
affiliation: Instituto Dante Pazzanese de Cardiologia
last name: FABIO H ROSSI, MD, PHD
role: Study Director
affiliation: Instituto Dante Pazzanese de Cardiologia
facility: 
country: Brazil
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responsible party type: Principal Investigator
investigator affiliation: Instituto Dante Pazzanese de Cardiologia
investigator full name: Fabio H Rossi
investigator title: MD, PHD
mesh term: Cardiovascular Diseases
mesh term: Atherosclerosis
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Vascular Diseases
mesh term: Chronic Limb-Threatening Ischemia
mesh term: Arteriosclerosis
mesh term: Arterial Occlusive Diseases
mesh term: Plaque, Atherosclerotic