<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/NCT04422054</url>
  </required_header>
  <id_info>
    <org_study_id>ER.ALL.2018.19.</org_study_id>
    <nct_id>NCT04422054</nct_id>
  </id_info>
  <brief_title>Aneurysm Diameter and Surgical Outcome</brief_title>
  <acronym>ADASO</acronym>
  <official_title>Correlation Between the Diameter of the Infrarenal Abdominal Aortic Aneurysms Treated With Open or Endovascular Surgical and the Post-procedural Outcomes.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Catanzaro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Catanzaro</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Aneurysm diameter is an important risk for rupture and related death in affected patients.&#xD;
&#xD;
      This study will evaluate whether aneurysms size may even influence post procedural outcomes&#xD;
      both in open surgical repair and in end-vascular aneurysm repair.&#xD;
&#xD;
      We will retrospectively review clinical data of operated patients with abdominal aortic&#xD;
      aneurysm. We will consider both open surgical repair and endovascular aneurysm repair&#xD;
      procedures in order to assess the influence of aneurysm size at the time of intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the publication by Szilagyi et al, size of aneurysms has been recognized as the&#xD;
      predominant risk factor for rupture. In fact, a low risk is associated with small aneurysms,&#xD;
      an intermediate risk with medium-sized aneurysms, and dramatically an increased risk with&#xD;
      large aneurysms. Current guidelines suggest that the threshold diameter for aneurysm surgery&#xD;
      being 5.5 cm for male patients and 5.0 cm for female patients, as measured on the largest&#xD;
      section of the aneurysm.&#xD;
&#xD;
      The correlation aneurysm diameter may also have an impact on early and late postoperative&#xD;
      outcomes both for open surgery and endovascular surgery. The study by Peppelenbosch N et al.&#xD;
      showed that size differences were strongly associated with adverse outcomes during follow-up&#xD;
      of patients that underwent endovascular aneurysm repair.&#xD;
&#xD;
      The aim of this is to assess the influence of aneurysm size on the early and late outcomes of&#xD;
      open surgical repair (OSR) and endovascular aneurysm repair (EVAR) of abdominal aortic&#xD;
      aneurysms (AAA).&#xD;
&#xD;
      Preoperative patient characteristics, comorbid conditions, aneurysm anatomy and diameters&#xD;
      will be retrospectively reviewed in order to correlate with the results of the procedures&#xD;
      (OSR and EVAR) and with adverse outcome that may have been occurred during follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2, 2020</start_date>
  <completion_date type="Anticipated">October 2, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between Aneurysm Diameter and Open Surgery Outcome</measure>
    <time_frame>5 years of follow up</time_frame>
    <description>We will correlate outcomes and complications with preoperative aneurysm size.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between Aneurysm Diameter and Endovascular Repair</measure>
    <time_frame>5 years of follow up</time_frame>
    <description>We will correlate outcomes and complications with preoperative aneurysm size.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Abdominal Aortic Aneurysm</condition>
  <condition>Surgery</condition>
  <condition>Outcome, Fatal</condition>
  <arm_group>
    <arm_group_label>Open Surgery Repair Group</arm_group_label>
    <description>In the open surgery repair group, preoperative patient characteristics, comorbid conditions, aneurysm anatomy and diameters will be matched with outcomes and complications, in the postoperative period, during follow up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endovascular Repair Group</arm_group_label>
    <description>In the endovascular surgery repair group, preoperative patient characteristics, comorbid conditions, aneurysm anatomy and diameters will be matched with outcomes and complications in the postoperative period, during follow up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open Surgery</intervention_name>
    <description>We will retrospectively review patients with abdominal aortic aneurysms that underwent open surgical repair.</description>
    <arm_group_label>Open Surgery Repair Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endovascular Surgery</intervention_name>
    <description>We will retrospectively review patients with abdominal aortic aneurysms that underwent endovascular repair.</description>
    <arm_group_label>Endovascular Repair Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        100 patients, of both sex, with abdominal aortic aneurysm who underwent open surgery or&#xD;
        endovascular procedures.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with abdominal aortic aneurysm who underwent open surgery or endovascular&#xD;
             procedures with complete anatomic data of aneurysms and clinical data with a minimus&#xD;
             of 5 years of follow up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>14743127 Serra, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Magna Graecia of Catanzaro</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Raffaele Serra, M.D., Ph.D.</last_name>
    <phone>+3909613647380</phone>
    <email>rserra@unicz.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>CIFL- Interuniversity Center of Phlebolymphology</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raffaele Serra, MD</last_name>
      <phone>+393387078043</phone>
      <email>rserra@unicz.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Szilagyi DE, Elliott JP, Smith RF. Clinical fate of the patient with asymptomatic abdominal aortic aneurysm and unfit for surgical treatment. Arch Surg. 1972 Apr;104(4):600-6. doi: 10.1001/archsurg.1972.04180040214036. No abstract available.</citation>
    <PMID>5013802</PMID>
  </reference>
  <reference>
    <citation>Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kolbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Document Reviewers, Bjorck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein HH, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco JB, Verhagen H. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8-93. doi: 10.1016/j.ejvs.2018.09.020. Epub 2018 Dec 5. No abstract available. Erratum In: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):494.</citation>
    <PMID>30528142</PMID>
  </reference>
  <reference>
    <citation>Peppelenbosch N, Buth J, Harris PL, van Marrewijk C, Fransen G; EUROSTAR Collaborators. Diameter of abdominal aortic aneurysm and outcome of endovascular aneurysm repair: does size matter? A report from EUROSTAR. J Vasc Surg. 2004 Feb;39(2):288-97. doi: 10.1016/j.jvs.2003.09.047.</citation>
    <PMID>14743127</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Catanzaro</investigator_affiliation>
    <investigator_full_name>Prof. Raffaele Serra, MD, Ph.D.</investigator_full_name>
    <investigator_title>Associate Professor of Vascular Surgery</investigator_title>
  </responsible_party>
  <keyword>open surgery</keyword>
  <keyword>endovascular repair</keyword>
  <keyword>aneurysm size</keyword>
  <keyword>outcome</keyword>
  <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>Aortic Aneurysm, Abdominal</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/NCT04422054
org study id: ER.ALL.2018.19.
nct id: NCT04422054
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aneurysm diameter is an important risk for rupture and related death in affected patients.

      This study will evaluate whether aneurysms size may even influence post procedural outcomes
      both in open surgical repair and in end-vascular aneurysm repair.

      We will retrospectively review clinical data of operated patients with abdominal aortic
      aneurysm. We will consider both open surgical repair and endovascular aneurysm repair
      procedures in order to assess the influence of aneurysm size at the time of intervention.
Since the publication by Szilagyi et al, size of aneurysms has been recognized as the
      predominant risk factor for rupture. In fact, a low risk is associated with small aneurysms,
      an intermediate risk with medium-sized aneurysms, and dramatically an increased risk with
      large aneurysms. Current guidelines suggest that the threshold diameter for aneurysm surgery
      being 5.5 cm for male patients and 5.0 cm for female patients, as measured on the largest
      section of the aneurysm.

      The correlation aneurysm diameter may also have an impact on early and late postoperative
      outcomes both for open surgery and endovascular surgery. The study by Peppelenbosch N et al.
      showed that size differences were strongly associated with adverse outcomes during follow-up
      of patients that underwent endovascular aneurysm repair.

      The aim of this is to assess the influence of aneurysm size on the early and late outcomes of
      open surgical repair (OSR) and endovascular aneurysm repair (EVAR) of abdominal aortic
      aneurysms (AAA).

      Preoperative patient characteristics, comorbid conditions, aneurysm anatomy and diameters
      will be retrospectively reviewed in order to correlate with the results of the procedures
      (OSR and EVAR) and with adverse outcome that may have been occurred during follow up.
observational model: Cohort
time perspective: Retrospective
measure: Correlation between Aneurysm Diameter and Open Surgery Outcome
time frame: 5 years of follow up
description: We will correlate outcomes and complications with preoperative aneurysm size.
measure: Correlation between Aneurysm Diameter and Endovascular Repair
time frame: 5 years of follow up
description: We will correlate outcomes and complications with preoperative aneurysm size.
arm group label: Open Surgery Repair Group
description: In the open surgery repair group, preoperative patient characteristics, comorbid conditions, aneurysm anatomy and diameters will be matched with outcomes and complications, in the postoperative period, during follow up.
arm group label: Endovascular Repair Group
description: In the endovascular surgery repair group, preoperative patient characteristics, comorbid conditions, aneurysm anatomy and diameters will be matched with outcomes and complications in the postoperative period, during follow up.
intervention type: Procedure
intervention name: Open Surgery
description: We will retrospectively review patients with abdominal aortic aneurysms that underwent open surgical repair.
arm group label: Open Surgery Repair Group
intervention type: Procedure
intervention name: Endovascular Surgery
description: We will retrospectively review patients with abdominal aortic aneurysms that underwent endovascular repair.
arm group label: Endovascular Repair Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: 14743127 Serra, M.D., Ph.D.
role: Principal Investigator
affiliation: University Magna Graecia of Catanzaro
last name: Raffaele Serra, M.D., Ph.D.
phone: +3909613647380
email: rserra@unicz.it
facility: 
status: Recruiting
contact: 
country: Italy
citation: Szilagyi DE, Elliott JP, Smith RF. Clinical fate of the patient with asymptomatic abdominal aortic aneurysm and unfit for surgical treatment. Arch Surg. 1972 Apr;104(4):600-6. doi: 10.1001/archsurg.1972.04180040214036. No abstract available.
PMID: 5013802
citation: Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kolbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Document Reviewers, Bjorck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein HH, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco JB, Verhagen H. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8-93. doi: 10.1016/j.ejvs.2018.09.020. Epub 2018 Dec 5. No abstract available. Erratum In: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):494.
PMID: 30528142
citation: Peppelenbosch N, Buth J, Harris PL, van Marrewijk C, Fransen G; EUROSTAR Collaborators. Diameter of abdominal aortic aneurysm and outcome of endovascular aneurysm repair: does size matter? A report from EUROSTAR. J Vasc Surg. 2004 Feb;39(2):288-97. doi: 10.1016/j.jvs.2003.09.047.
PMID: 14743127
responsible party type: Principal Investigator
investigator affiliation: University of Catanzaro
investigator full name: Prof. Raffaele Serra, MD, Ph.D.
investigator title: Associate Professor of Vascular Surgery
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal
sharing ipd: No