<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/NCT03040063</url>
  </required_header>
  <id_info>
    <org_study_id>EVAR-P</org_study_id>
    <nct_id>NCT03040063</nct_id>
  </id_info>
  <brief_title>Complex Endovascular Approach to Treatment of Patients With Aneurysm of Popliteal Artery</brief_title>
  <acronym>EVAR-P</acronym>
  <official_title>Complex Endovascular Approach to Treatment of Patients With Aneurysm of Popliteal Artery and Acute Limb Ischemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Petr Varejka</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charles University, Czech Republic</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>
      Use of endovascular techniques - implantation of a peripheral stent graft and a peripheral&#xD;
      flexible stent to isolate the sac of the popliteal artery aneurysm from the circulation and&#xD;
      subsequent topical application of a thrombolytic (rtPA) to restore patency of the lower leg&#xD;
      blood stream - will lead to a comparable or better outcome in treatment of patients with the&#xD;
      popliteal artery aneurysm and acute critical limb ischaemia, compared to currently prevailing&#xD;
      use of surgical treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The 2nd Medical Department admits patients with acute arterial occlusion at the stage of&#xD;
      critical limb ischaemia. The poorest prognosis considering preservation of the limb is shown&#xD;
      by the patients who exhibit symptoms of ischaemia due to affected popliteal artery and&#xD;
      arteries of the shank in the the popliteal artery aneurysm. On the other hand, diagnosis of&#xD;
      this condition is prompt and easy (general ultrasound scan below the knee). Patients with the&#xD;
      popliteal artery aneurysm, confirmed by ultrasound investigation, and concurrent signs and&#xD;
      symptoms of acute critical ischaemia will be indicated for catheterization intervention at&#xD;
      our unit, which will confirm morphological compatibility with endovascular occlusion of the&#xD;
      aneurysm sac through implantation of a peripheral stent graft, supported by implantation of a&#xD;
      peripheral flexible stent, and at the same time insertion of a thrombolytic catheter into the&#xD;
      implanted stent graft for local thrombolysis of tibial arteries if required by the current&#xD;
      situation. The patient will be hospitalized at the angiology intensive care unit of the 2nd&#xD;
      Medical Department, where local intra-arterial thrombolytic therapy will be performed&#xD;
      according to the standard protocol. After completion of the proper endovascular treatment,&#xD;
      the patients will be transferred to combined peroral anticoagulation and antiaggregation&#xD;
      treatment, and all of them will have an ultrasound scan below the knee, with the readings&#xD;
      archived for the purpose of further comparison and monitoring. Subsequently, the patients&#xD;
      will be monitored in the outpatient regime after 6 weeks, 3, 6 and 12 months. At each visit,&#xD;
      clinical examination will be done including establishment of ABI/TBI values and ultrasound&#xD;
      investigation of the region below the knee.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Anticipated">August 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2018</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Limb salvage in 12 months</measure>
    <time_frame>12 Months</time_frame>
    <description>Limba salvage in 12 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patency of the popliteal artery in 12 months</measure>
    <time_frame>12 Months</time_frame>
    <description>Patency of the popliteal artery in 12 months</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Aneurysm; Popliteal Artery</condition>
  <condition>Limb Ischemia</condition>
  <arm_group>
    <arm_group_label>Combined endovascular approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combined endovascular approach using covered stent and flexible stent in the popliteal artery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard optimal therapy (OPT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>standard therapy of popliteal artery aneurysm using thrombolysis and surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Combined endovascular approach (EVAR)</intervention_name>
    <description>puncture of SFA in orthograde position if possible&#xD;
DSA through 4F dilator, proof of occlusion&#xD;
wire test&#xD;
Heparin 70-80 IU/kg i.a.&#xD;
implantation of peripheral stent graft VIABAHN&#xD;
implantation of peripheral stent SUPERA into stent graft&#xD;
insertion of strait flush catheter for local thrombolysis&#xD;
administration of continuous local thrombolysis in the dose of 1 mg/hr., unfractionated heparin continuously (APTT 1,5-2x) according to the department standards&#xD;
control angiography in 12 hrs or earlier according to clinical status and symptoms&#xD;
repeated angiography in 24 hrs</description>
    <arm_group_label>Combined endovascular approach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard optimal therapy (OPT)</intervention_name>
    <description>puncture of SFA in orthograde position if possible&#xD;
DSA through 4F dilator, proof of occlusion&#xD;
wire test&#xD;
Unfractionated heparin 70-80 IU/kg i.a.&#xD;
insertion of strait flush catheter for local thrombolysis&#xD;
administration of continuous local thrombolysis in the dose of 1 mg/hr., unfractionated heparin continuously (APTTT 1,5-2x)&#xD;
control angiography in 12 hrs or according to clinical status and symptoms&#xD;
repeated angiography in24 hrs&#xD;
Final result review, vascular team consultation and indication for surgical or conservative management of popliteal artery aneurysm.</description>
    <arm_group_label>Standard optimal therapy (OPT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent form for the patient's participation in the study.&#xD;
&#xD;
          2. Acute critical limb ischaemia with impairment of the extremity at stage I, IIa, IIb&#xD;
             according to SVS classification.&#xD;
&#xD;
          3. A popliteal artery aneurysm, confirmed by ultrasound scanning, which on&#xD;
             catheterization examination meets the criteria for isolation of the aneurysm sac by&#xD;
             implantation of a peripheral stent graft, supported by insertion of a peripheral&#xD;
             flexible stent.&#xD;
&#xD;
          4. Absence of any contraindication for local thrombolytic therapy.&#xD;
&#xD;
          5. An anatomic finding through angiographic investigation that is suitable for&#xD;
             endovascular therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active bleeding or contraindication for local thrombolysis.&#xD;
&#xD;
          2. Life expectance &lt; 1 yr&#xD;
&#xD;
          3. Relevant stenotic defects of valves.&#xD;
&#xD;
          4. Myocardial infarction or unstable angina pectoris in past 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jean Claude Lubanda, Ass.Prof., MD., Ph.D.</last_name>
    <phone>00420224962692</phone>
    <email>Jean-Claude.Lubanda@vfn.cz</email>
  </overall_contact>
  <location>
    <facility>
      <name>Charles University in Prague</name>
      <address>
        <city>Prague</city>
        <zip>12808</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean Claude Lubanda, Ass.Prof.MD</last_name>
      <phone>+420224962692</phone>
      <email>Jean-Claude.Lubanda@vfn.cz</email>
    </contact>
    <contact_backup>
      <last_name>Martina Striteska, Mgr.</last_name>
      <phone>+224962605</phone>
      <email>Martina.Striteska@vfn.cz</email>
    </contact_backup>
    <investigator>
      <last_name>Jean-Claude Lubanda, Ass.Prof.MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Czech Republic</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charles University, Czech Republic</investigator_affiliation>
    <investigator_full_name>Ass. prof. Jean-Claude M. Lubanda, MD, Ph.D</investigator_full_name>
    <investigator_title>Ass.prof. MD, Ph.D.</investigator_title>
  </responsible_party>
  <keyword>aneurysm, poplietl artery, acute limb ischemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Popliteal Artery Aneurysm</mesh_term>
    <mesh_term>Ischemia</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/NCT03040063
org study id: EVAR-P
nct id: NCT03040063
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Use of endovascular techniques - implantation of a peripheral stent graft and a peripheral
      flexible stent to isolate the sac of the popliteal artery aneurysm from the circulation and
      subsequent topical application of a thrombolytic (rtPA) to restore patency of the lower leg
      blood stream - will lead to a comparable or better outcome in treatment of patients with the
      popliteal artery aneurysm and acute critical limb ischaemia, compared to currently prevailing
      use of surgical treatment.
The 2nd Medical Department admits patients with acute arterial occlusion at the stage of
      critical limb ischaemia. The poorest prognosis considering preservation of the limb is shown
      by the patients who exhibit symptoms of ischaemia due to affected popliteal artery and
      arteries of the shank in the the popliteal artery aneurysm. On the other hand, diagnosis of
      this condition is prompt and easy (general ultrasound scan below the knee). Patients with the
      popliteal artery aneurysm, confirmed by ultrasound investigation, and concurrent signs and
      symptoms of acute critical ischaemia will be indicated for catheterization intervention at
      our unit, which will confirm morphological compatibility with endovascular occlusion of the
      aneurysm sac through implantation of a peripheral stent graft, supported by implantation of a
      peripheral flexible stent, and at the same time insertion of a thrombolytic catheter into the
      implanted stent graft for local thrombolysis of tibial arteries if required by the current
      situation. The patient will be hospitalized at the angiology intensive care unit of the 2nd
      Medical Department, where local intra-arterial thrombolytic therapy will be performed
      according to the standard protocol. After completion of the proper endovascular treatment,
      the patients will be transferred to combined peroral anticoagulation and antiaggregation
      treatment, and all of them will have an ultrasound scan below the knee, with the readings
      archived for the purpose of further comparison and monitoring. Subsequently, the patients
      will be monitored in the outpatient regime after 6 weeks, 3, 6 and 12 months. At each visit,
      clinical examination will be done including establishment of ABI/TBI values and ultrasound
      investigation of the region below the knee.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Limb salvage in 12 months
time frame: 12 Months
description: Limba salvage in 12 months
measure: Patency of the popliteal artery in 12 months
time frame: 12 Months
description: Patency of the popliteal artery in 12 months
arm group label: Combined endovascular approach
arm group type: Experimental
description: Combined endovascular approach using covered stent and flexible stent in the popliteal artery
arm group label: Standard optimal therapy (OPT)
arm group type: Experimental
description: standard therapy of popliteal artery aneurysm using thrombolysis and surgery
intervention type: Procedure
intervention name: Combined endovascular approach (EVAR)
description: puncture of SFA in orthograde position if possible
DSA through 4F dilator, proof of occlusion
wire test
Heparin 70-80 IU/kg i.a.
implantation of peripheral stent graft VIABAHN
implantation of peripheral stent SUPERA into stent graft
insertion of strait flush catheter for local thrombolysis
administration of continuous local thrombolysis in the dose of 1 mg/hr., unfractionated heparin continuously (APTT 1,5-2x) according to the department standards
control angiography in 12 hrs or earlier according to clinical status and symptoms
repeated angiography in 24 hrs
arm group label: Combined endovascular approach
intervention type: Procedure
intervention name: Standard optimal therapy (OPT)
description: puncture of SFA in orthograde position if possible
DSA through 4F dilator, proof of occlusion
wire test
Unfractionated heparin 70-80 IU/kg i.a.
insertion of strait flush catheter for local thrombolysis
administration of continuous local thrombolysis in the dose of 1 mg/hr., unfractionated heparin continuously (APTTT 1,5-2x)
control angiography in 12 hrs or according to clinical status and symptoms
repeated angiography in24 hrs
Final result review, vascular team consultation and indication for surgical or conservative management of popliteal artery aneurysm.
arm group label: Standard optimal therapy (OPT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jean Claude Lubanda, Ass.Prof., MD., Ph.D.
phone: 00420224962692
email: Jean-Claude.Lubanda@vfn.cz
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Czech Republic
responsible party type: Principal Investigator
investigator affiliation: Charles University, Czech Republic
investigator full name: Ass. prof. Jean-Claude M. Lubanda, MD, Ph.D
investigator title: Ass.prof. MD, Ph.D.
mesh term: Aneurysm
mesh term: Popliteal Artery Aneurysm
mesh term: Ischemia
sharing ipd: No