<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/NCT03227822</url>
  </required_header>
  <id_info>
    <org_study_id>STRONG SFA study</org_study_id>
    <secondary_id>NL43610.060.13</secondary_id>
    <nct_id>NCT03227822</nct_id>
  </id_info>
  <brief_title>Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease</brief_title>
  <acronym>STRONG</acronym>
  <official_title>Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease; a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catharina Ziekenhuis Eindhoven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catharina Ziekenhuis Eindhoven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since the length of lesion seems to be negatively associated with stent patency due to&#xD;
      restenosis, it is thought that the efficacy of treatment in patients with multiple (&gt; 1)&#xD;
      short (focal; &gt; 1 and &lt; 5 cm) SFA lesions can be improved by spot stenting as compared to the&#xD;
      use of one long stent. This study proposes to evaluate the endovascular treatment for&#xD;
      patients with SFA lesions by comparing two strategies for patients with extensive occlusive&#xD;
      SFA disease; 1) short spot (SS) stenting or 2) long lesion (LL) stenting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to include the number of patients&#xD;
  </why_stopped>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">February 1, 2015</completion_date>
  <primary_completion_date type="Actual">February 1, 2015</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>absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>Short spot stenting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Short spot stenting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Long lesion stenting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Long lesion stenting</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Short spot stenting</intervention_name>
    <arm_group_label>Short spot stenting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Long lesion stenting</intervention_name>
    <arm_group_label>Long lesion stenting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PAOD (ABI &lt;0.90 and/or a decline of &gt;0.15 after exercise test), Rutherford category 2,&#xD;
             3 or 4&#xD;
&#xD;
          -  Multiple (&gt;1) short (focal; &gt;1 and &lt; 5 cm) significant stenoses (≥ 50%) and/or&#xD;
             occlusions in the superficial femoral artery&#xD;
&#xD;
          -  Eligible for endovascular treatment via short spot stenting and via long lesion&#xD;
             stenting according to international guidelines&#xD;
&#xD;
          -  Unilateral occlusive disease&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with PAOD Rutherford category 5 and 6&#xD;
&#xD;
          -  Impaired inflow due to significant lesions in the arteries proximal to the SFA&#xD;
             intended to treat&#xD;
&#xD;
          -  Bilateral lesions with treatment indication&#xD;
&#xD;
          -  Contra-indication for anticoagulant therapy&#xD;
&#xD;
          -  Renal insufficiency (MDRD &lt; 50 ml/min)&#xD;
&#xD;
          -  Life expectancy &lt; 6 months&#xD;
&#xD;
          -  Known contrast allergy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Unable to complete a questionnaire in the home language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>October 5, 2018</last_update_submitted>
  <last_update_submitted_qc>October 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catharina Ziekenhuis Eindhoven</investigator_affiliation>
    <investigator_full_name>Marc van Sambeek</investigator_full_name>
    <investigator_title>MD, PhD, vascular surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</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/NCT03227822
org study id: STRONG SFA study
secondary id: NL43610.060.13
nct id: NCT03227822
lead sponsor: 
has dmc: No
Since the length of lesion seems to be negatively associated with stent patency due to
      restenosis, it is thought that the efficacy of treatment in patients with multiple (> 1)
      short (focal; > 1 and < 5 cm) SFA lesions can be improved by spot stenting as compared to the
      use of one long stent. This study proposes to evaluate the endovascular treatment for
      patients with SFA lesions by comparing two strategies for patients with extensive occlusive
      SFA disease; 1) short spot (SS) stenting or 2) long lesion (LL) stenting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention
time frame: 1 year
arm group label: Short spot stenting
arm group type: Experimental
description: Short spot stenting
arm group label: Long lesion stenting
arm group type: Experimental
description: Long lesion stenting
intervention type: Procedure
intervention name: Short spot stenting
arm group label: Short spot stenting
intervention type: Procedure
intervention name: Long lesion stenting
arm group label: Long lesion stenting
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Catharina Ziekenhuis Eindhoven
investigator full name: Marc van Sambeek
investigator title: MD, PhD, vascular surgeon
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases