<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/NCT02229370</url>
  </required_header>
  <id_info>
    <org_study_id>CAR2014</org_study_id>
    <nct_id>NCT02229370</nct_id>
  </id_info>
  <brief_title>Carotid Aneurysm Registry</brief_title>
  <acronym>CAR</acronym>
  <official_title>Extracranial Carotid Artery Aneurysm Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UMC Utrecht</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To prospectively collect data on ECAA we designed the Carotid Aneurysm Registry (CAR). The&#xD;
      aim of this study is to collect data on ECAA and its treatment to assess the natural history&#xD;
      of ECAA and the success and safety of different treatment strategies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CAR is a prospective observational study, initiated by the Department of Vascular Surgery at&#xD;
      University Medical Centre Utrecht (UMCU), The Netherlands. The study is descriptive in&#xD;
      nature. The registry will be conducted according to the principles of the Declaration of&#xD;
      Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013). The medical ethics&#xD;
      committee of the UMCU has approved the study and all patients must give written informed&#xD;
      consent before enrollment. Study enrolment is open to any patient diagnosed with an ECAA and&#xD;
      ongoing.&#xD;
&#xD;
      Enrollment criteria: Participation in the CAR is intended for all subjects diagnosed with an&#xD;
      ECAA irrespective of chosen treatment. Aneurysms are defined as 150% dilatation of the normal&#xD;
      vessel diameter, or any saccular aneurysm. To be included, aneurysms must be located in the&#xD;
      CCA, the external carotid artery or in the extracranial part of the ICA.To be included in the&#xD;
      registry, patients need to be 18 years old. There are no additional exclusion criteria.&#xD;
&#xD;
      Intervention and follow-up:CAR does not interfere with the physician's treatment decision.&#xD;
      Follow-up visits and imaging studies are scheduled as usual in their clinical practice, as&#xD;
      this study does also not interfere with or influence the follow-up regimen.&#xD;
&#xD;
      Study endpoints:The primary endpoint of the CAR is freedom from aneurysm related symptoms at&#xD;
      30 days and at mid- and longterm follow-up. The secondary endpoint comprises treatment&#xD;
      safety.&#xD;
&#xD;
      Endpoint monitoring:An endpoint adjudication committee, consisting of clinical experts, is&#xD;
      set up to harmonize and standardize endpoint assessment and to determine whether the&#xD;
      endpoints meet described criteria. This committee will review important subjective endpoints&#xD;
      reported by trial investigators. The members of this committee are blinded to the treatment&#xD;
      regime.&#xD;
&#xD;
      Data collection and monitoring: Data collected will be recorded through a web-based case&#xD;
      report form (CRF). Data will be collected at baseline, at the moment of intervention, at the&#xD;
      30-day (or first postoperative) visit and during the follow-up phase. Data will remain at the&#xD;
      UMCU in a secure environment.&#xD;
&#xD;
      This registry is a multicenter study. Statistical analysis: Statistical analyses will be&#xD;
      performed using SPSS software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>aneurysms related symptoms</measure>
    <time_frame>5 years</time_frame>
    <description>Aneurysm related symptoms such as ipsilateral stroke, TIA or compression. Disability is assessed by the Rankin scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of peri- and postoperative complications.</measure>
    <time_frame>30 days</time_frame>
    <description>Treatment safety includes peri- and postoperative complications and registration of reinterventions performed within 30days after initial treatment. Complications include peripheral nerve dysfunction, local hematoma or infection, local pain or headache, TIA, stroke, local bleeding or aneurysm rupture and all-cause mortality.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Extracranial Carotid Artery Aneurysm</condition>
  <arm_group>
    <arm_group_label>ECAA</arm_group_label>
    <description>all patients diagnosed with an extracranial carotid artery aneurysm</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood withdrawel&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participation in the CAR is intended for all subjects diagnosed with an extracranial&#xD;
        carotid artery aneurysm irrespective of chosen treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individual has one or more aneurysms of the extracranial carotid artery. Defined as&#xD;
             150% dilatation of the normal vessel diameter, or any saccular aneurysm.&#xD;
&#xD;
          -  Individual is ≥18 years of age.&#xD;
&#xD;
          -  Individual has signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gert Jan de Borst, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMC Utrecht</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gert Jan de Borst, MD, PhD</last_name>
    <phone>+31-88-7556965</phone>
    <email>g.j.deBorst-2@umcutrecht.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Medical Center Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3508 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gert Jan de Borst, MD, PhD</last_name>
      <phone>+31-88-7556965</phone>
      <email>g.j.deBorst-2@umcutrecht.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://carotidaneurysmregistry.com</url>
    <description>Click here for more information about this study: Carotid Aneurysm Registry</description>
  </link>
  <reference>
    <citation>Welleweerd JC, Bots ML, Kappelle LJ, Rinkel GJ, Ruigrok YM, Baas AF, van der Worp HB, Vergouwen MD, Bleys RL, Hendrikse J, Lo TR, Moll FL, de Borst GJ. Rationale and design of the extracranial Carotid artery Aneurysm Registry (CAR). J Cardiovasc Surg (Torino). 2018 Oct;59(5):692-698. doi: 10.23736/S0021-9509.16.08637-7. Epub 2015 Feb 6.</citation>
    <PMID>25658976</PMID>
  </reference>
  <reference>
    <citation>Welleweerd JC, de Borst GJ; Carotid Aneurysm Registry Project Group. Extracranial carotid artery aneurysm: optimal treatment approach. Eur J Vasc Endovasc Surg. 2015 Mar;49(3):235-6. doi: 10.1016/j.ejvs.2014.11.007. Epub 2014 Dec 9. No abstract available.</citation>
    <PMID>25500055</PMID>
  </reference>
  <reference>
    <citation>Welleweerd JC, Nelissen BG, Koole D, de Vries JP, Moll FL, Pasterkamp G, Vink A, de Borst GJ. Histological analysis of extracranial carotid artery aneurysms. PLoS One. 2015 Jan 30;10(1):e0117915. doi: 10.1371/journal.pone.0117915. eCollection 2015.</citation>
    <PMID>25635813</PMID>
  </reference>
  <reference>
    <citation>Welleweerd JC, de Borst GJ, de Groot D, van Herwaarden JA, Lo RT, Moll FL. Bare metal stents for treatment of extracranial internal carotid artery aneurysms: long-term results. J Endovasc Ther. 2015 Feb;22(1):130-4. doi: 10.1177/1526602814566405.</citation>
    <PMID>25775693</PMID>
  </reference>
  <reference>
    <citation>Welleweerd JC, Moll FL, de Borst GJ. Technical options for the treatment of extracranial carotid aneurysms. Expert Rev Cardiovasc Ther. 2012 Jul;10(7):925-31. doi: 10.1586/erc.12.61.</citation>
    <PMID>22908925</PMID>
  </reference>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>December 10, 2015</last_update_submitted>
  <last_update_submitted_qc>December 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UMC Utrecht</investigator_affiliation>
    <investigator_full_name>Gert Jan de Borst</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>extracranial</keyword>
  <keyword>carotid</keyword>
  <keyword>artery</keyword>
  <keyword>aneurysm</keyword>
  <keyword>registry</keyword>
  <keyword>CAR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</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/NCT02229370
org study id: CAR2014
nct id: NCT02229370
lead sponsor: 
has dmc: No
To prospectively collect data on ECAA we designed the Carotid Aneurysm Registry (CAR). The
      aim of this study is to collect data on ECAA and its treatment to assess the natural history
      of ECAA and the success and safety of different treatment strategies.
CAR is a prospective observational study, initiated by the Department of Vascular Surgery at
      University Medical Centre Utrecht (UMCU), The Netherlands. The study is descriptive in
      nature. The registry will be conducted according to the principles of the Declaration of
      Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013). The medical ethics
      committee of the UMCU has approved the study and all patients must give written informed
      consent before enrollment. Study enrolment is open to any patient diagnosed with an ECAA and
      ongoing.

      Enrollment criteria: Participation in the CAR is intended for all subjects diagnosed with an
      ECAA irrespective of chosen treatment. Aneurysms are defined as 150% dilatation of the normal
      vessel diameter, or any saccular aneurysm. To be included, aneurysms must be located in the
      CCA, the external carotid artery or in the extracranial part of the ICA.To be included in the
      registry, patients need to be 18 years old. There are no additional exclusion criteria.

      Intervention and follow-up:CAR does not interfere with the physician's treatment decision.
      Follow-up visits and imaging studies are scheduled as usual in their clinical practice, as
      this study does also not interfere with or influence the follow-up regimen.

      Study endpoints:The primary endpoint of the CAR is freedom from aneurysm related symptoms at
      30 days and at mid- and longterm follow-up. The secondary endpoint comprises treatment
      safety.

      Endpoint monitoring:An endpoint adjudication committee, consisting of clinical experts, is
      set up to harmonize and standardize endpoint assessment and to determine whether the
      endpoints meet described criteria. This committee will review important subjective endpoints
      reported by trial investigators. The members of this committee are blinded to the treatment
      regime.

      Data collection and monitoring: Data collected will be recorded through a web-based case
      report form (CRF). Data will be collected at baseline, at the moment of intervention, at the
      30-day (or first postoperative) visit and during the follow-up phase. Data will remain at the
      UMCU in a secure environment.

      This registry is a multicenter study. Statistical analysis: Statistical analyses will be
      performed using SPSS software.
observational model: Cohort
time perspective: Prospective
measure: aneurysms related symptoms
time frame: 5 years
description: Aneurysm related symptoms such as ipsilateral stroke, TIA or compression. Disability is assessed by the Rankin scale.
measure: number of peri- and postoperative complications.
time frame: 30 days
description: Treatment safety includes peri- and postoperative complications and registration of reinterventions performed within 30days after initial treatment. Complications include peripheral nerve dysfunction, local hematoma or infection, local pain or headache, TIA, stroke, local bleeding or aneurysm rupture and all-cause mortality.
arm group label: ECAA
description: all patients diagnosed with an extracranial carotid artery aneurysm
blood withdrawel
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: Gert Jan de Borst, MD, PhD
role: Principal Investigator
affiliation: UMC Utrecht
last name: Gert Jan de Borst, MD, PhD
phone: +31-88-7556965
email: g.j.deBorst-2@umcutrecht.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
url: http://carotidaneurysmregistry.com
description: Click here for more information about this study: Carotid Aneurysm Registry
citation: Welleweerd JC, Bots ML, Kappelle LJ, Rinkel GJ, Ruigrok YM, Baas AF, van der Worp HB, Vergouwen MD, Bleys RL, Hendrikse J, Lo TR, Moll FL, de Borst GJ. Rationale and design of the extracranial Carotid artery Aneurysm Registry (CAR). J Cardiovasc Surg (Torino). 2018 Oct;59(5):692-698. doi: 10.23736/S0021-9509.16.08637-7. Epub 2015 Feb 6.
PMID: 25658976
citation: Welleweerd JC, de Borst GJ; Carotid Aneurysm Registry Project Group. Extracranial carotid artery aneurysm: optimal treatment approach. Eur J Vasc Endovasc Surg. 2015 Mar;49(3):235-6. doi: 10.1016/j.ejvs.2014.11.007. Epub 2014 Dec 9. No abstract available.
PMID: 25500055
citation: Welleweerd JC, Nelissen BG, Koole D, de Vries JP, Moll FL, Pasterkamp G, Vink A, de Borst GJ. Histological analysis of extracranial carotid artery aneurysms. PLoS One. 2015 Jan 30;10(1):e0117915. doi: 10.1371/journal.pone.0117915. eCollection 2015.
PMID: 25635813
citation: Welleweerd JC, de Borst GJ, de Groot D, van Herwaarden JA, Lo RT, Moll FL. Bare metal stents for treatment of extracranial internal carotid artery aneurysms: long-term results. J Endovasc Ther. 2015 Feb;22(1):130-4. doi: 10.1177/1526602814566405.
PMID: 25775693
citation: Welleweerd JC, Moll FL, de Borst GJ. Technical options for the treatment of extracranial carotid aneurysms. Expert Rev Cardiovasc Ther. 2012 Jul;10(7):925-31. doi: 10.1586/erc.12.61.
PMID: 22908925
responsible party type: Principal Investigator
investigator affiliation: UMC Utrecht
investigator full name: Gert Jan de Borst
investigator title: MD PhD
mesh term: Aneurysm