<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/NCT03824730</url>
  </required_header>
  <id_info>
    <org_study_id>CCSerbia Vasc</org_study_id>
    <nct_id>NCT03824730</nct_id>
  </id_info>
  <brief_title>Endovascular Treatment of Aorto-iliac Occlusions</brief_title>
  <official_title>Endovascular Treatment of Different Types of Aorto-iliac Occlusions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Centre of Serbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Centre of Serbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares early and long-term results of the endovascular treatment among patients&#xD;
      with different types of aorto-iliac occlusions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endovascular treatment has been increasingly applied as a therapeutic option for aorto-iliac&#xD;
      occlusive disease during the last decade, becoming the first-line treatment for many of the&#xD;
      Trans-Atlantic Inter-Society Consensus document II (TASC II) categories. TASC II document in&#xD;
      2007 stated endovascular treatment as the method of choice up to type B occlusions and&#xD;
      surgery for low-risk patients with type C and D occlusions, emphasizing that the patient's&#xD;
      comorbidities as well as the operator's long-term success rates should be included in the&#xD;
      decision-making process.&#xD;
&#xD;
      Revision of TASC II document in 2015 is suggesting that the preferred revascularization&#xD;
      method should be based on each vascular center's competence and experience with the anatomic&#xD;
      complexity, considering patient comorbidity and overall prognosis, supporting the&#xD;
      endovascular-first approach in all 4 different kinds of lesions in highly experienced&#xD;
      centers.&#xD;
&#xD;
      These changes over time are based on expert opinions derived from smaller studies from high&#xD;
      volume centers, and that they reflect both the widespread gain of endovascular experience and&#xD;
      technical developments over the last 2 decades, leading to a rising number of centers&#xD;
      providing an endovascular-first approach even in complex TASC C and D occlusions.&#xD;
&#xD;
      Rationale for offering endovascular-first option to patient with complex lesion would be low&#xD;
      risk of complication and long-term patency.&#xD;
&#xD;
      Our intention is to compare early and long-term results of the endovascular treatment among&#xD;
      patients with different types of aorto-iliac occlusions in two Serbian vascular centres.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">November 1, 2017</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Primary artery/stent patency rate</measure>
    <time_frame>60 Months</time_frame>
    <description>Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary assisted artery/stent patency rate</measure>
    <time_frame>60 months</time_frame>
    <description>Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (&gt;70%) at any time post-procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary patency artery/stent rate</measure>
    <time_frame>60 months</time_frame>
    <description>Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at any time post-procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>60 months</time_frame>
    <description>During the follow-up period, the improvement of Rutherford classification 1 grade or more than 1 grade.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with periprocedural complications: hematoma, bleeding, pseudoaneurysm, renal failure, myocardial infarction, stroke, mortality, thrombosis of the treated segment</measure>
    <time_frame>1 month</time_frame>
    <description>Identification of serious adverse events requiring correction of therapy or surgery. Will be used physiological parameter and questionnaire.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Aorto-Iliac Occlusive Disease</condition>
  <condition>Iliac Artery Occlusion</condition>
  <condition>Iliac Artery Disease</condition>
  <arm_group>
    <arm_group_label>Endovascular occlusions group</arm_group_label>
    <description>Group of patients with aorto-iliac occlusive disease (TASC B, C, D) in whom stenting of the Common and/or External Iliac Arteries were performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stenting of the Common and/or External Iliac Arteries</intervention_name>
    <description>Stenting of the Common and/or External Iliac Arteries was performed in the angiographic suite. Under local anesthesia, arterial access was obtained through standard percutaneous puncture of the common femoral artery, brachial approach, or simultaneous brachial and femoral approach.&#xD;
Iliac lesion crossing was achieved through intraluminal or subintimal manner depending on the behavior of the lesion intraoperatively.&#xD;
Predilatation of the occlusion before stent deployment was performed at the discretion of the operator.&#xD;
Balloon-expandable stents were used for proximal, ostial lesions, whereas self-expanding stents were deployed in all other lesions.&#xD;
Both stents were used in long lesions involving heavily calcified common iliac arteries.</description>
    <arm_group_label>Endovascular occlusions group</arm_group_label>
    <other_name>Percutaneous Transluminal Angioplasty</other_name>
    <other_name>stent implantation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with endovascular stent due to aorto-iliac occlusions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has aorto-iliac occlusions type B, C &amp; D according to TASC-II classification&#xD;
&#xD;
          -  Patient suffers from severe claudication (Rutherford 3) or critical limb ischemia&#xD;
             (Rutherford 4 and 5)&#xD;
&#xD;
          -  Patients fulfilling criteria for endovascular treatment of aorto-iliac occlusion&#xD;
             according to criteria of the participating centres.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with associated abdominal or iliac aneurysm, restenotic lesions, acute&#xD;
             thrombi or dissections,&#xD;
&#xD;
          -  Patients who experienced an initial technical failure&#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>Dragan Z Sagic, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Cardiovascular Diseases Dedinje</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Center of Serbia</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Cardiovascular Diseases Dedinje</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Centre of Serbia</investigator_affiliation>
    <investigator_full_name>Vladimir Cvetic</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>endovascular</keyword>
  <keyword>stent</keyword>
  <keyword>aorto-iliac</keyword>
  <keyword>occlusions</keyword>
  <keyword>iliac</keyword>
  <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/NCT03824730
org study id: CCSerbia Vasc
nct id: NCT03824730
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compares early and long-term results of the endovascular treatment among patients
      with different types of aorto-iliac occlusions.
Endovascular treatment has been increasingly applied as a therapeutic option for aorto-iliac
      occlusive disease during the last decade, becoming the first-line treatment for many of the
      Trans-Atlantic Inter-Society Consensus document II (TASC II) categories. TASC II document in
      2007 stated endovascular treatment as the method of choice up to type B occlusions and
      surgery for low-risk patients with type C and D occlusions, emphasizing that the patient's
      comorbidities as well as the operator's long-term success rates should be included in the
      decision-making process.

      Revision of TASC II document in 2015 is suggesting that the preferred revascularization
      method should be based on each vascular center's competence and experience with the anatomic
      complexity, considering patient comorbidity and overall prognosis, supporting the
      endovascular-first approach in all 4 different kinds of lesions in highly experienced
      centers.

      These changes over time are based on expert opinions derived from smaller studies from high
      volume centers, and that they reflect both the widespread gain of endovascular experience and
      technical developments over the last 2 decades, leading to a rising number of centers
      providing an endovascular-first approach even in complex TASC C and D occlusions.

      Rationale for offering endovascular-first option to patient with complex lesion would be low
      risk of complication and long-term patency.

      Our intention is to compare early and long-term results of the endovascular treatment among
      patients with different types of aorto-iliac occlusions in two Serbian vascular centres.
observational model: Cohort
time perspective: Prospective
measure: Primary artery/stent patency rate
time frame: 60 Months
description: Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation.
measure: Primary assisted artery/stent patency rate
time frame: 60 months
description: Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (>70%) at any time post-procedure.
measure: Secondary patency artery/stent rate
time frame: 60 months
description: Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at any time post-procedure
measure: Clinical success
time frame: 60 months
description: During the follow-up period, the improvement of Rutherford classification 1 grade or more than 1 grade.
measure: Number of participants with periprocedural complications: hematoma, bleeding, pseudoaneurysm, renal failure, myocardial infarction, stroke, mortality, thrombosis of the treated segment
time frame: 1 month
description: Identification of serious adverse events requiring correction of therapy or surgery. Will be used physiological parameter and questionnaire.
arm group label: Endovascular occlusions group
description: Group of patients with aorto-iliac occlusive disease (TASC B, C, D) in whom stenting of the Common and/or External Iliac Arteries were performed
intervention type: Device
intervention name: Stenting of the Common and/or External Iliac Arteries
description: Stenting of the Common and/or External Iliac Arteries was performed in the angiographic suite. Under local anesthesia, arterial access was obtained through standard percutaneous puncture of the common femoral artery, brachial approach, or simultaneous brachial and femoral approach.
Iliac lesion crossing was achieved through intraluminal or subintimal manner depending on the behavior of the lesion intraoperatively.
Predilatation of the occlusion before stent deployment was performed at the discretion of the operator.
Balloon-expandable stents were used for proximal, ostial lesions, whereas self-expanding stents were deployed in all other lesions.
Both stents were used in long lesions involving heavily calcified common iliac arteries.
arm group label: Endovascular occlusions group
other name: Percutaneous Transluminal Angioplasty
other name: stent implantation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dragan Z Sagic, Prof
role: Principal Investigator
affiliation: Institute for Cardiovascular Diseases Dedinje
facility: 
facility: 
country: Serbia
responsible party type: Principal Investigator
investigator affiliation: Clinical Centre of Serbia
investigator full name: Vladimir Cvetic
investigator title: Principal Investigator
sharing ipd: No