<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/NCT04507334</url>
  </required_header>
  <id_info>
    <org_study_id>ID-RCB/EUDRACT</org_study_id>
    <nct_id>NCT04507334</nct_id>
  </id_info>
  <brief_title>Secondary Rupture of Aortic Aneurysm Post EVAR</brief_title>
  <official_title>Secondary Rupture of Aortic Aneurysm After EVAR Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-stent rupture of the abdominal aorta is a rare occurrence and with few publications:&#xD;
      only 2 multicenter studies and one meta-analysis in 2017 listed this complication As well as&#xD;
      a few cases reports This study, the first carried out in France, aims to describe the&#xD;
      survival in patients with secondary rupture of the aneurysm despite initial treatment with&#xD;
      EVAR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 15, 2020</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>describe survival in patient with secondary rupture aneurysm despite endovascular treatment</measure>
    <time_frame>20 years</time_frame>
    <description>mortality describe in the group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare survival in patients with rupture secondary aneurysm despite treatment</measure>
    <time_frame>20 years</time_frame>
    <description>with endovascular according to:&#xD;
management of secondary rupture of the aneurysm&#xD;
the hemodynamic state on arrival in the center treating&#xD;
the size of the aneurysm sac</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2) Explore the risk factors for mortality in study patients</measure>
    <time_frame>20 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Aortic Aneurysm</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with ruptured aortic aneurysm + EVAR&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Patient who had a ruptured aortic aneurysm between 01/01/1993 and 07/31/2020)&#xD;
&#xD;
          -  Patients whose aortic aneurysm has been treated with EVAR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No&#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_contact>
    <last_name>camille salomon</last_name>
    <phone>0688027932</phone>
    <email>salomoncamille@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Serguei Malikov</last_name>
    <phone>0679322495</phone>
    <email>s.malikov@chru-nancy.fr</email>
  </overall_contact_backup>
  <reference>
    <citation>Schlosser FJ, Gusberg RJ, Dardik A, Lin PH, Verhagen HJ, Moll FL, Muhs BE. Aneurysm rupture after EVAR: can the ultimate failure be predicted? Eur J Vasc Endovasc Surg. 2009 Jan;37(1):15-22. doi: 10.1016/j.ejvs.2008.10.011. Epub 2008 Nov 12.</citation>
    <PMID>19008129</PMID>
  </reference>
  <reference>
    <citation>Powell JT, Sweeting MJ, Ulug P, Blankensteijn JD, Lederle FA, Becquemin JP, Greenhalgh RM; EVAR-1, DREAM, OVER and ACE Trialists. Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years. Br J Surg. 2017 Feb;104(3):166-178. doi: 10.1002/bjs.10430. Erratum In: Br J Surg. 2018 Aug;105(9):1222.</citation>
    <PMID>28160528</PMID>
  </reference>
  <reference>
    <citation>Wyss TR, Brown LC, Powell JT, Greenhalgh RM. Rate and predictability of graft rupture after endovascular and open abdominal aortic aneurysm repair: data from the EVAR Trials. Ann Surg. 2010 Nov;252(5):805-12. doi: 10.1097/SLA.0b013e3181fcb44a.</citation>
    <PMID>21037436</PMID>
  </reference>
  <reference>
    <citation>Torsello GB, Klenk E, Kasprzak B, Umscheid T. Rupture of abdominal aortic aneurysm previously treated by endovascular stentgraft. J Vasc Surg. 1998 Jul;28(1):184-7. doi: 10.1016/s0741-5214(98)70214-9.</citation>
    <PMID>9685145</PMID>
  </reference>
  <reference>
    <citation>Alimi YS, Chakfe N, Rivoal E, Slimane KK, Valerio N, Riepe G, Kretz JG, Juhan C. Rupture of an abdominal aortic aneurysm after endovascular graft placement and aneurysm size reduction. J Vasc Surg. 1998 Jul;28(1):178-83. doi: 10.1016/s0741-5214(98)70213-7.</citation>
    <PMID>9685144</PMID>
  </reference>
  <reference>
    <citation>Fransen GA, Vallabhaneni SR Sr, van Marrewijk CJ, Laheij RJ, Harris PL, Buth J; EUROSTAR. Rupture of infra-renal aortic aneurysm after endovascular repair: a series from EUROSTAR registry. Eur J Vasc Endovasc Surg. 2003 Nov;26(5):487-93. doi: 10.1016/s1078-5884(03)00350-2.</citation>
    <PMID>14532875</PMID>
  </reference>
  <reference>
    <citation>Bernhard VM, Mitchell RS, Matsumura JS, Brewster DC, Decker M, Lamparello P, Raithel D, Collin J. Ruptured abdominal aortic aneurysm after endovascular repair. J Vasc Surg. 2002 Jun;35(6):1155-62. doi: 10.1067/mva.2002.123758.</citation>
    <PMID>12042725</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04507334
org study id: ID-RCB/EUDRACT
nct id: NCT04507334
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Post-stent rupture of the abdominal aorta is a rare occurrence and with few publications:
      only 2 multicenter studies and one meta-analysis in 2017 listed this complication As well as
      a few cases reports This study, the first carried out in France, aims to describe the
      survival in patients with secondary rupture of the aneurysm despite initial treatment with
      EVAR.
observational model: Case-Only
time perspective: Retrospective
measure: describe survival in patient with secondary rupture aneurysm despite endovascular treatment
time frame: 20 years
description: mortality describe in the group
measure: Compare survival in patients with rupture secondary aneurysm despite treatment
time frame: 20 years
description: with endovascular according to:
management of secondary rupture of the aneurysm
the hemodynamic state on arrival in the center treating
the size of the aneurysm sac
measure: 2) Explore the risk factors for mortality in study patients
time frame: 20 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: camille salomon
phone: 0688027932
email: salomoncamille@gmail.com
last name: Serguei Malikov
phone: 0679322495
email: s.malikov@chru-nancy.fr
citation: Schlosser FJ, Gusberg RJ, Dardik A, Lin PH, Verhagen HJ, Moll FL, Muhs BE. Aneurysm rupture after EVAR: can the ultimate failure be predicted? Eur J Vasc Endovasc Surg. 2009 Jan;37(1):15-22. doi: 10.1016/j.ejvs.2008.10.011. Epub 2008 Nov 12.
PMID: 19008129
citation: Powell JT, Sweeting MJ, Ulug P, Blankensteijn JD, Lederle FA, Becquemin JP, Greenhalgh RM; EVAR-1, DREAM, OVER and ACE Trialists. Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years. Br J Surg. 2017 Feb;104(3):166-178. doi: 10.1002/bjs.10430. Erratum In: Br J Surg. 2018 Aug;105(9):1222.
PMID: 28160528
citation: Wyss TR, Brown LC, Powell JT, Greenhalgh RM. Rate and predictability of graft rupture after endovascular and open abdominal aortic aneurysm repair: data from the EVAR Trials. Ann Surg. 2010 Nov;252(5):805-12. doi: 10.1097/SLA.0b013e3181fcb44a.
PMID: 21037436
citation: Torsello GB, Klenk E, Kasprzak B, Umscheid T. Rupture of abdominal aortic aneurysm previously treated by endovascular stentgraft. J Vasc Surg. 1998 Jul;28(1):184-7. doi: 10.1016/s0741-5214(98)70214-9.
PMID: 9685145
citation: Alimi YS, Chakfe N, Rivoal E, Slimane KK, Valerio N, Riepe G, Kretz JG, Juhan C. Rupture of an abdominal aortic aneurysm after endovascular graft placement and aneurysm size reduction. J Vasc Surg. 1998 Jul;28(1):178-83. doi: 10.1016/s0741-5214(98)70213-7.
PMID: 9685144
citation: Fransen GA, Vallabhaneni SR Sr, van Marrewijk CJ, Laheij RJ, Harris PL, Buth J; EUROSTAR. Rupture of infra-renal aortic aneurysm after endovascular repair: a series from EUROSTAR registry. Eur J Vasc Endovasc Surg. 2003 Nov;26(5):487-93. doi: 10.1016/s1078-5884(03)00350-2.
PMID: 14532875
citation: Bernhard VM, Mitchell RS, Matsumura JS, Brewster DC, Decker M, Lamparello P, Raithel D, Collin J. Ruptured abdominal aortic aneurysm after endovascular repair. J Vasc Surg. 2002 Jun;35(6):1155-62. doi: 10.1067/mva.2002.123758.
PMID: 12042725
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Rupture
sharing ipd: Undecided